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Active, not recruitingNCT04822480Updated Apr 29, 2024

Evaluation of a Telehealth DPP With Medicare Patients at the University of Mississippi Medical Center

An observational study in PreDiabetes and Prediabetic State, sponsored by University of Mississippi Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-29.

Sponsored by University of Mississippi Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

The National Diabetes Prevention Program (DPP) is an evidence-based, 12-month lifestyle change program to prevent or delay the onset of type 2 diabetes mellitus (herein referred to as 'diabetes') among adults with prediabetes. The Department of Preventive Medicine, University of Mississippi Medical Center (UMMC), in partnership with the American Medical Association, is collaborating to develop and implement the DPP as a clinical service for UMMC patients beginning in September 2020. We aim to recruit 245 patients per year over 3 years. Because this is the first attempt to develop and implement the DPP as a clinical service at the UMMC, we are proposing to conduct a comprehensive process, outcome, impact and return on investment evaluation. An effectiveness-implementation hybrid research design will be used to (1) evaluate a multifaceted implementation strategy and the effectiveness and impact of the DPP delivered using telehealth by UMMC's Department of Preventive Medicine; (2) conduct an analysis on medical expenditures among those who participate in a DPP to measure net savings and return on investment (ROI) relative to non-participants; (3) conduct a longitudinal cohort analysis to assess incidence of diabetes and changes in body composition, biomarkers, and psycho-social behavioral constructs among those who participate in a DPP relative to those who do not.

The findings from this comprehensive research evaluation will be used to (1) improve clinical operations and implementation; (2) demonstrate the cost benefit of the DPP as a clinical service for patients with diabetes risk; and (3) provide empirical support for delivering the DPP via different modalities including telehealth to reduce risk and improve health outcomes among patients.

Read the detailed description

The purpose of this research is to: (1) Evaluate a multifaceted implementation strategy for the uptake of a remote DPP by UMMC's Department of Preventive Medicine. (2) Conduct an analysis on medical expenditures among those who participate in a DPP to measure net savings and ROI relative to non-participants. (3) Conduct a longitudinal cohort analysis to assess incidence of diabetes, body composition, biomarkers, and psycho-social behavioral constructs among those who participate in a DPP relative to those who do not. Study methods are described below according to each of three specific aims.

Aim 1: Conduct a concurrent implementation and effectiveness evaluation of the DPP in a clinical care setting for patients with prediabetes (n=245). An effectiveness-implementation hybrid type III research design will be used to conduct a non-randomized trial with 245 of patients with prediabetes over a three year recruitment period, while employing an iterative process evaluation to explore the complex processes, dynamic context and organizational influences on implementation. The RE-AIM framework will guide the implementation and effectiveness evaluation including measures of Reach, Effectiveness, Adoption, Implementation and Maintenance. Multiple data sources and data types will be used to assess barriers and facilitators that affect the RE-AIM domains, as well as fidelity, costs, patient satisfaction and physician burnout.

Aim 2: Utilize claims and encounters data to measure medical expenditures for patients with prediabetes, and determine spending differentials among DPP participants compared with non-DPP participants. Track trends in per capita medical expenditures for among a panel of case (DPP participant) and control (Non-DPP participant) subjects. To compare variations in spending, the differences in the arithmetic means, compound annual growth rates, and propensity score matching models will be implemented to compare case and control subjects. The study may also look at those with prediabetes that are later diagnosed with diabetes and individuals with prediabetes who are not later diagnosed with the condition. These estimates of spending differentials and evidence of DPP participation and engagement rates will help to further enhance the algorithm to estimate the potential cost savings and ROI if diabetes is prevented or delayed in the at-risk population who participate in the DPP.

Aim 3: Assess the longitudinal effect of the DPP on participant changes in cardiovascular disease risk including anthropometric and clinical biomarker and psychosocial health outcomes (N=245). A prospective, repeated measures, experimental cohort design will be used to determine the long-term impact of the DPP on diabetes incidence and cardiovascular disease risk among DPP patient participants.

02

Conditions studied

  • PreDiabetes
  • Prediabetic State

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Keywords

  • diabetes prevention
03

In context

Prediabetic State

999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.

This study's planned enrollment of 500 is above the median of 216 across 128 observational studies indexed under Prediabetic State.

Browse Prediabetic State studies →

Lead sponsor

University of Mississippi Medical Center is the lead sponsor of 125 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Mississippi consistently has among the highest rates of diabetes (14.3%) and prediabetes (36.5%) nationally and is the only state where every county (82 counties) are represented in the Diabetes Belt, a geographic region of the U.S. where the prevalence of diagnosed diabetes is highest. Mississippi has the fourth largest rural population (51.2%) and the highest state percent Black (37.8%) population in the U.S., and has persistently high rates of poverty (20.8%).

Inclusion criteria

  • UMMC patient within the previous 3-years (at least one UMMC clinical visit within the previous 3-years)
  • ≥ 18 years AND
  • Clinical diagnosis for prediabetes (R73.03)

OR any of the following combinations:

  • BMI ≥25 (non-Asian) OR
  • BMI ≥23 (Asian) AND
  • HbA1c 5.7 - 6.4 percent within the past 12-months OR
  • Fasting plasma glucose 110 - 125 mg/dL within the past 12-months OR
  • 2-hour plasma glucose 140 - 199 mg/dL within the past 12-months

Exclusion criteria

Exclusion Criteria:

  • Pregnant or planning to become pregnant within the next 12 months
  • \<18 years
  • Primary or secondary diagnosis of diabetes mellitus (all codes with prefix of 250 and 249) and other conditions associated with diabetes (357.2, all codes with prefix 362, 366.41, and all codes with prefix 648).
  • End stage renal disease
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • DPP Patients

    UMMC Patients with prediabetes or risk for diabetes based on risk parameters referred to and enrolled in the DPP.

    Behavioral: Diabetes Prevention Program (DPP)

  • Non-DPP Patients

    Control matched UMMC patients with prediabetes or risk for diabetes based on risk parameters not enrolled in the DPP.

Interventions

  • BehavioralDiabetes Prevention Program (DPP)

    Individuals with prediabetes can mitigate the risks and costs of diabetes by taking preventative action, such as participation in a National Diabetes Prevention Program (DPP). The DPP began as a multisite randomized controlled trial demonstrating the effectiveness and cost-benefit of a 12-month intensive lifestyle intervention over pharmaceutical treatment for preventing or delaying diabetes among prediabetic participants. In 2010, Congress authorized the Centers for Disease Control and Prevention to lead the dissemination of the DPP as a targeted approach (high risk populations) and population-based strategy to reduce the incidence of diabetes and diabetes-related healthcare costs. The goal is to achieve modest weight loss (7%) by developing and implementing behavior change skills resulting in lifestyle modifications such as physical activity (150 minutes per week) and dietary and nutritional practices.

06

What researchers measure

Primary outcomes

  1. Type 2 diabetes mellitus diagnosis

    Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249

    Time frame: Change diabetes diagnosis from baseline to 6-months in DPP compared with non-DPP patients

  2. Type 2 diabetes mellitus diagnosis

    Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249

    Time frame: Change diabetes diagnosis from baseline to 12-months in DPP compared with non-DPP patients

  3. Type 2 diabetes mellitus diagnosis

    Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249

    Time frame: Change diabetes diagnosis from baseline to 18-months in DPP compared with non-DPP patients

  4. Type 2 diabetes mellitus diagnosis

    Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249

    Time frame: Change diabetes diagnosis from baseline to 24-months in DPP compared with non-DPP patients

  5. Type 2 diabetes mellitus diagnosis

    Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249

    Time frame: Change diabetes diagnosis from baseline to 30-months in DPP compared with non-DPP patients

  6. Type 2 diabetes mellitus diagnosis

    Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249

    Time frame: Change diabetes diagnosis from baseline to 36-months in DPP compared with non-DPP patients

  7. Hemoglobin A1c

    Lab values extracted from electronic health record

    Time frame: Change in HbA1c from baseline to 6-months in DPP compared with non-DPP patients

  8. Hemoglobin A1c

    Lab values extracted from electronic health record

    Time frame: Change in HbA1c from baseline to 12-months in DPP compared with non-DPP patients

  9. Hemoglobin A1c

    Lab values extracted from electronic health record

    Time frame: Change in HbA1c from baseline to 18-months in DPP compared with non-DPP patients

  10. Hemoglobin A1c

    Lab values extracted from electronic health record

    Time frame: Change in HbA1c from baseline to 24-months in DPP compared with non-DPP patients

  11. Hemoglobin A1c

    Lab values extracted from electronic health record

    Time frame: Change in HbA1c from baseline to 30-months in DPP compared with non-DPP patients

  12. Hemoglobin A1c

    Lab values extracted from electronic health record

    Time frame: Change in HbA1c from baseline to 36-months in DPP compared with non-DPP patients

  13. Fasting plasma glucose

    Lab values extracted from electronic health record

    Time frame: Change in fasting plasma glucose from baseline to 6-months in DPP compared with non-DPP patients

  14. Fasting plasma glucose

    Lab values extracted from electronic health record

    Time frame: Change in fasting plasma glucose from baseline to 12-months in DPP compared with non-DPP patients

  15. Fasting plasma glucose

    Lab values extracted from electronic health record

    Time frame: Change in fasting plasma glucose from baseline to 18-months in DPP compared with non-DPP patients

  16. Fasting plasma glucose

    Lab values extracted from electronic health record

    Time frame: Change in fasting plasma glucose from baseline to 24-months in DPP compared with non-DPP patients

  17. Fasting plasma glucose

    Lab values extracted from electronic health record

    Time frame: Change in fasting plasma glucose from baseline to 30-months in DPP compared with non-DPP patients

  18. Fasting plasma glucose

    Lab values extracted from electronic health record

    Time frame: Change in fasting plasma glucose from baseline to 36-months in DPP compared with non-DPP patients

  19. 2-hour plasma glucose

    Lab values extracted from electronic health record

    Time frame: Change in 2-hour plasma glucose from baseline to 6-months in DPP compared with non-DPP patients

  20. 2-hour plasma glucose

    Lab values extracted from electronic health record

    Time frame: Change in 2-hour plasma glucose from baseline to 12-months in DPP compared with non-DPP patients

  21. 2-hour plasma glucose

    Lab values extracted from electronic health record

    Time frame: Change in 2-hour plasma glucose from baseline to 18-months in DPP compared with non-DPP patients

  22. 2-hour plasma glucose

    Lab values extracted from electronic health record

    Time frame: Change in 2-hour plasma glucose from baseline to 24-months in DPP compared with non-DPP patients

  23. 2-hour plasma glucose

    Lab values extracted from electronic health record

    Time frame: Change in 2-hour plasma glucose from baseline to 30-months in DPP compared with non-DPP patients

  24. 2-hour plasma glucose

    Lab values extracted from electronic health record

    Time frame: Change in 2-hour plasma glucose from baseline to 36-months in DPP compared with non-DPP patients

  25. Medical encounters

    Extracted from electronic health record

    Time frame: Number of medical encounters between baseline and 6-months in DPP compared with non-DPP patients

  26. Medical encounters

    Extracted from electronic health record

    Time frame: Number of medical encounters between baseline and 12-months in DPP compared with non-DPP patients

  27. Medical encounters

    Extracted from electronic health record

    Time frame: Number of medical encounters between baseline and 18-months in DPP compared with non-DPP patients

  28. Medical encounters

    Extracted from electronic health record

    Time frame: Number of medical encounters between baseline and 24-months in DPP compared with non-DPP patients

  29. Medical encounters

    Extracted from electronic health record

    Time frame: Number of medical encounters between baseline and 30-months in DPP compared with non-DPP patients

  30. Medical encounters

    Extracted from electronic health record

    Time frame: Number of medical encounters between baseline and 36-months in DPP compared with non-DPP patients

  31. Medical expenditures

    Total dollar amount billed per encounter extracted from electronic health record

    Time frame: Medical expenditures from baseline to 6-months in DPP compared with non-DPP patients

  32. Medical expenditures

    Total dollar amount billed per encounter extracted from electronic health record

    Time frame: Medical expenditures from baseline to 12-months in DPP compared with non-DPP patients

  33. Medical expenditures

    Total dollar amount billed per encounter extracted from electronic health record

    Time frame: Medical expenditures from baseline to 18-months in DPP compared with non-DPP patients

  34. Medical expenditures

    Total dollar amount billed per encounter extracted from electronic health record

    Time frame: Medical expenditures from baseline to 24-months in DPP compared with non-DPP patients

  35. Medical expenditures

    Total dollar amount billed per encounter extracted from electronic health record

    Time frame: Medical expenditures from baseline to 30-months in DPP compared with non-DPP patients

  36. Medical expenditures

    Total dollar amount billed per encounter extracted from electronic health record

    Time frame: Medical expenditures from baseline to 36-months in DPP compared with non-DPP patients

Secondary outcomes

  1. Body weight

    Total body weight measured using Seca mBCA 554

    Time frame: Change in body weight from baseline to 6-months

  2. Body weight

    Total body weight measured using Seca mBCA 554

    Time frame: Change in body weight from baseline to 12-months

  3. Body weight

    Total body weight measured using Seca mBCA 554

    Time frame: Change in body weight from baseline to 24-months

  4. Body weight

    Total body weight measured using Seca mBCA 554

    Time frame: Change in body weight from baseline to 36-months

  5. Fat mass

    Total body fat mass measured using Seca mBCA 554; bioimpedance analysis

    Time frame: Change in fat mass from baseline to 6-months

  6. Fat mass

    Total body fat mass measured using Seca mBCA 554; bioimpedance analysis

    Time frame: Change in fat mass from baseline to 12-months

  7. Fat mass

    Total body fat mass measured using Seca mBCA 554; bioimpedance analysis

    Time frame: Change in fat mass from baseline to 24-months

  8. Fat mass

    Total body fat mass measured using Seca mBCA 554; bioimpedance analysis

    Time frame: Change in fat mass from baseline to 36-months

  9. Visceral fat

    Visceral fat measured using Seca mBCA 554; bioimpedance analysis

    Time frame: Change in visceral fat from baseline to 6-months

  10. Visceral fat

    Visceral fat measured using Seca mBCA 554; bioimpedance analysis

    Time frame: Change in visceral fat from baseline to 12-months

  11. Visceral fat

    Visceral fat measured using Seca mBCA 554; bioimpedance analysis

    Time frame: Change in visceral fat from baseline to 24-months

  12. Visceral fat

    Visceral fat measured using Seca mBCA 554; bioimpedance analysis

    Time frame: Change in visceral fat from baseline to 36-months

  13. Skeletal muscle mass

    Total body skeletal muscle mass measured using Seca mBCA 554; bioimpedance analysis

    Time frame: Change in skeletal muscle mass from baseline to 6-months

  14. Skeletal muscle mass

    Total body skeletal muscle mass measured using Seca mBCA 554; bioimpedance analysis

    Time frame: Change in skeletal muscle mass from baseline to 12-months

  15. Skeletal muscle mass

    Total body skeletal muscle mass measured using Seca mBCA 554; bioimpedance analysis

    Time frame: Change in skeletal muscle mass from baseline to 24-months

  16. Skeletal muscle mass

    Total body skeletal muscle mass measured using Seca mBCA 554; bioimpedance analysis

    Time frame: Change in skeletal muscle mass from baseline to 36-months

  17. Waist circumference

    Measures using Seca 203 circumference measuring tape

    Time frame: Change in waist circumference from baseline to 6-months

  18. Waist circumference

    Measures using Seca 203 circumference measuring tape

    Time frame: Change in waist circumference from baseline to 12-months

  19. Waist circumference

    Measures using Seca 203 circumference measuring tape

    Time frame: Change in waist circumference from baseline to 24-months

  20. Waist circumference

    Measures using Seca 203 circumference measuring tape

    Time frame: Change in waist circumference from baseline to 36-months

  21. Systolic blood pressure

    Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.

    Time frame: Change in systolic blood pressure from baseline to 6-months

  22. Systolic blood pressure

    Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.

    Time frame: Change in systolic blood pressure from baseline to 12-months

  23. Systolic blood pressure

    Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.

    Time frame: Change in systolic blood pressure from baseline to 24-months

  24. Systolic blood pressure

    Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.

    Time frame: Change in systolic blood pressure from baseline to 36-months

  25. Diastolic blood pressure

    Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.

    Time frame: Change in diastolic blood pressure from baseline to 6-months

  26. Diastolic blood pressure

    Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.

    Time frame: Change in diastolic blood pressure from baseline to 12-months

  27. Diastolic blood pressure

    Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.

    Time frame: Change in diastolic blood pressure from baseline to 24-months

  28. Diastolic blood pressure

    Welch Allyn blood pressure unit following the American Heart Association guidelines for adults.

    Time frame: Change in diastolic blood pressure from baseline to 36-months

  29. Resting heart rate

    Welch Allyn blood pressure unit.

    Time frame: Change in resting heart rate from baseline to 6-months

  30. Resting heart rate

    Welch Allyn blood pressure unit.

    Time frame: Change in resting heart rate from baseline to 12-months

  31. Resting heart rate

    Welch Allyn blood pressure unit.

    Time frame: Change in resting heart rate from baseline to 24-months

  32. Resting heart rate

    Welch Allyn blood pressure unit.

    Time frame: Change in resting heart rate from baseline to 36-months

  33. Total cholesterol

    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood

    Time frame: Change in total cholesterol from baseline to 6-months

  34. Total cholesterol

    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood

    Time frame: Change in total cholesterol from baseline to 12-months

  35. Total cholesterol

    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood

    Time frame: Change in total cholesterol from baseline to 24-months

  36. Total cholesterol

    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood

    Time frame: Change in total cholesterol from baseline to 36-months

  37. HDL cholesterol

    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood

    Time frame: Change in HDL cholesterol from baseline to 6-months

  38. HDL cholesterol

    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood

    Time frame: Change in HDL cholesterol from baseline to 12-months

  39. HDL cholesterol

    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood

    Time frame: Change in HDL cholesterol from baseline to 24-months

  40. HDL cholesterol

    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood

    Time frame: Change in HDL cholesterol from baseline to 36-months

  41. Triglycerides

    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood

    Time frame: Change in triglycerides from baseline to 6-months

  42. Triglycerides

    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood

    Time frame: Change in triglycerides from baseline to 12-months

  43. Triglycerides

    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood

    Time frame: Change in triglycerides from baseline to 24-months

  44. Triglycerides

    PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood

    Time frame: Change in triglycerides from baseline to 36-months

  45. Hemoglobin A1c (point of care)

    A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood

    Time frame: Change in HbA1c from baseline to 6-months

  46. Hemoglobin A1c (point of care)

    A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood

    Time frame: Change in HbA1c from baseline to 12-months

  47. Hemoglobin A1c (point of care)

    A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood

    Time frame: Change in HbA1c from baseline to 24-months

  48. Hemoglobin A1c (point of care)

    A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood

    Time frame: Change in HbA1c from baseline to 36-months

  49. Self-efficacy for weight loss and maintenance

    Weight self-efficacy lifestyle questionnaire; 20 items using a 10-point Likert scale; higher mean score indicates higher self-efficacy; Clark et al., 1991

    Time frame: Change in self-efficacy from baseline to 6-months

  50. Self-efficacy for weight loss and maintenance

    Weight self-efficacy lifestyle questionnaire; 20 items using a 10-point Likert scale; higher mean score indicates higher self-efficacy; Clark et al., 1991

    Time frame: Change in self-efficacy from baseline to 12-months

  51. Self-efficacy for weight loss and maintenance

    Weight self-efficacy lifestyle questionnaire; 20 items using a 10-point Likert scale; higher mean score indicates higher self-efficacy; Clark et al., 1991

    Time frame: Change in self-efficacy from baseline to 24-months

  52. Self-efficacy for weight loss and maintenance

    Weight self-efficacy lifestyle questionnaire; 20 items using a 10-point Likert scale; higher mean score indicates higher self-efficacy; Clark et al., 1991

    Time frame: Change in self-efficacy from baseline to 36-months

  53. Readiness to change, stage of change

    Stages of Change in Overweight and Obese People questionnaire (S-weight); 1-item with 5 distinct and mutually exclusive responses to measure stage of change; Andres et al., 2009

    Time frame: Change in stage of change from baseline to 6-months

  54. Readiness to change, stage of change

    Stages of Change in Overweight and Obese People questionnaire (S-weight); 1-item with 5 distinct and mutually exclusive responses to measure stage of change; Andres et al., 2009

    Time frame: Change in stage of change from baseline to 12-months

  55. Readiness to change, stage of change

    Stages of Change in Overweight and Obese People questionnaire (S-weight); 1-item with 5 distinct and mutually exclusive responses to measure stage of change; Andres et al., 2009

    Time frame: Change in stage of change from baseline to 24-months

  56. Readiness to change, stage of change

    Stages of Change in Overweight and Obese People questionnaire (S-weight); 1-item with 5 distinct and mutually exclusive responses to measure stage of change; Andres et al., 2009

    Time frame: Change in stage of change from baseline to 36-months

  57. Readiness to change, processes of change

    Processes of Change in Overweight and Obese People questionnaire (P-weight); 34 items; 5-point Likert scale from Strongly Disagree to Strongly Agree where higher mean score indicates higher use of respective process; four processes include emotional re-evaluation, weight consequences evaluation, supporting relationships, and weight management actions across 4 processes of change; Andres et al., 2011

    Time frame: Change in processes of change from baseline to 6-months

  58. Readiness to change, processes of change

    Processes of Change in Overweight and Obese People questionnaire (P-weight); 34 items; 5-point Likert scale from Strongly Disagree to Strongly Agree where higher mean score indicates higher use of respective process; four processes include emotional re-evaluation, weight consequences evaluation, supporting relationships, and weight management actions across 4 processes of change; Andres et al., 2011

    Time frame: Change in processes of change from baseline to 12-months

  59. Readiness to change, processes of change

    Processes of Change in Overweight and Obese People questionnaire (P-weight); 34 items; 5-point Likert scale from Strongly Disagree to Strongly Agree where higher mean score indicates higher use of respective process; four processes include emotional re-evaluation, weight consequences evaluation, supporting relationships, and weight management actions across 4 processes of change; Andres et al., 2011

    Time frame: Change in processes of change from baseline to 24-months

  60. Readiness to change, processes of change

    Processes of Change in Overweight and Obese People questionnaire (P-weight); 34 items; 5-point Likert scale from Strongly Disagree to Strongly Agree where higher mean score indicates higher use of respective process; four processes include emotional re-evaluation, weight consequences evaluation, supporting relationships, and weight management actions across 4 processes of change; Andres et al., 2011

    Time frame: Change in processes of change from baseline to 36-months

  61. Decisional balance

    Decisional balance inventory; 20 items using 5-point Likert scale to identify cognitive and emotional pros and cons to making intentional changes for weight loss and maintenance (Not Important At All to Extremely Important); higher mean scores for subscales (Pros; Pro-Con) would indicate higher intention; O'Connell and Velicer, 1988

    Time frame: Change in decisional balance from baseline to 6-months

  62. Decisional balance

    Decisional balance inventory; 20 items using 5-point Likert scale to identify cognitive and emotional pros and cons to making intentional changes for weight loss and maintenance (Not Important At All to Extremely Important); higher mean scores for subscales (Pros; Pro-Con) would indicate higher intention; O'Connell and Velicer, 1988

    Time frame: Change in decisional balance from baseline to 12-months

  63. Decisional balance

    Decisional balance inventory; 20 items using 5-point Likert scale to identify cognitive and emotional pros and cons to making intentional changes for weight loss and maintenance (Not Important At All to Extremely Important); higher mean scores for subscales (Pros; Pro-Con) would indicate higher intention; O'Connell and Velicer, 1988

    Time frame: Change in decisional balance from baseline to 24-months

  64. Decisional balance

    Decisional balance inventory; 20 items using 5-point Likert scale to identify cognitive and emotional pros and cons to making intentional changes for weight loss and maintenance (Not Important At All to Extremely Important); higher mean scores for subscales (Pros; Pro-Con) would indicate higher intention; O'Connell and Velicer, 1988

    Time frame: Change in decisional balance from baseline to 36-months

  65. Self-efficacy for overcoming barriers to physical activity and healthy eating

    Self-efficacy for overcoming barriers to physical activity and diet; 10 items using a 4-point Likert scale from Very Uncertain to Very Certain or Not True At All to Exactly True; higher mean score (20 to 80) indicated greater self-efficacy; Huttunen-Lenz et al., 2018

    Time frame: Change in barrier self-efficacy from baseline to 6-months

  66. Self-efficacy for overcoming barriers to physical activity and healthy eating

    Self-efficacy for overcoming barriers to physical activity and diet; 10 items using a 4-point Likert scale from Very Uncertain to Very Certain or Not True At All to Exactly True; higher mean score (20 to 80) indicated greater self-efficacy; Huttunen-Lenz et al., 2018

    Time frame: Change in barrier self-efficacy from baseline to 12-months

  67. Self-efficacy for overcoming barriers to physical activity and healthy eating

    Self-efficacy for overcoming barriers to physical activity and diet; 10 items using a 4-point Likert scale from Very Uncertain to Very Certain or Not True At All to Exactly True; higher mean score (20 to 80) indicated greater self-efficacy; Huttunen-Lenz et al., 2018

    Time frame: Change in barrier self-efficacy from baseline to 24-months

  68. Self-efficacy for overcoming barriers to physical activity and healthy eating

    Self-efficacy for overcoming barriers to physical activity and diet; 10 items using a 4-point Likert scale from Very Uncertain to Very Certain or Not True At All to Exactly True; higher mean score (20 to 80) indicated greater self-efficacy; Huttunen-Lenz et al., 2018

    Time frame: Change in barrier self-efficacy from baseline to 36-months

  69. Self-regulation of eating behaviors

    Self-regulation of Eating Behavior Questionnaire; 5 items using a 5-point Likert scale; mean score \<2.8, 2.8 - 3.6, \>3.6 correspond to low, medium and high self-regulation, respectively; Kliemann et al., 2016

    Time frame: Change in self-regulation of eating behaviors from baseline to 6-months

  70. Self-regulation of eating behaviors

    Self-regulation of Eating Behavior Questionnaire; 5 items using a 5-point Likert scale; mean score \<2.8, 2.8 - 3.6, \>3.6 correspond to low, medium and high self-regulation, respectively; Kliemann et al., 2016

    Time frame: Change in self-regulation of eating behaviors from baseline to 12-months

  71. Self-regulation of eating behaviors

    Self-regulation of Eating Behavior Questionnaire; 5 items using a 5-point Likert scale; mean score \<2.8, 2.8 - 3.6, \>3.6 correspond to low, medium and high self-regulation, respectively; Kliemann et al., 2016

    Time frame: Change in self-regulation of eating behaviors from baseline to 24-months

  72. Self-regulation of eating behaviors

    Self-regulation of Eating Behavior Questionnaire; 5 items using a 5-point Likert scale; mean score \<2.8, 2.8 - 3.6, \>3.6 correspond to low, medium and high self-regulation, respectively; Kliemann et al., 2016

    Time frame: Change in self-regulation of eating behaviors from baseline to 36-months

  73. Self-regulation of physical activity - goals

    Exercise goal-setting scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002

    Time frame: Change in self-regulation of physical activity goals from baseline to 6-months

  74. Self-regulation of physical activity - goals

    Exercise goal-setting scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002

    Time frame: Change in self-regulation of physical activity goals from baseline to 12-months

  75. Self-regulation of physical activity - goals

    Exercise goal-setting scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002

    Time frame: Change in self-regulation of physical activity goals from baseline to 24-months

  76. Self-regulation of physical activity - goals

    Exercise goal-setting scale; 10 items using 5-point Likert scale from Does Not Exercise goal-setting scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002

    Time frame: Change in self-regulation of physical activity goals from baseline to 36-months

  77. Self-regulation of physical activity - planning

    Exercise planning and scheduling scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002

    Time frame: Change in self-regulation of physical activity planning from baseline to 6-months

  78. Self-regulation of physical activity - planning

    Exercise planning and scheduling scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002

    Time frame: Change in self-regulation of physical activity planning from baseline to 12-months

  79. Self-regulation of physical activity - planning

    Exercise planning and scheduling scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002

    Time frame: Change in self-regulation of physical activity planning from baseline to 24-months

  80. Self-regulation of physical activity - planning

    Exercise planning and scheduling scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002

    Time frame: Change in self-regulation of physical activity planning from baseline to 36-months

  81. Social support from friends - eating

    Friend social support for healthy eating scale; 10 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987

    Time frame: Change in social support from baseline to 6-months

  82. Social support from friends - eating

    Friend social support for healthy eating scale; 10 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987

    Time frame: Change in social support from baseline to 12-months

  83. Social support from friends - eating

    Friend social support for healthy eating scale; 10 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987

    Time frame: Change in social support from baseline to 24-months

  84. Social support from friends - eating

    Friend social support for healthy eating scale; 10 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987

    Time frame: Change in social support from baseline to 36-months

  85. Social support from family - eating

    Family social support for healthy eating scale; 13 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987

    Time frame: Change in social support from baseline to 6-months

  86. Social support from family - eating

    Family social support for healthy eating scale; 13 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987

    Time frame: Change in social support from baseline to 12-months

  87. Social support from family - eating

    Family social support for healthy eating scale; 13 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987

    Time frame: Change in social support from baseline to 24-months

  88. Social support from family - eating

    Family social support for healthy eating scale; 13 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987

    Time frame: Change in social support from baseline to 36-months

  89. Social support from friend - physical activity

    Friend social support for physical activity scale; 9-items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987

    Time frame: Change in social support from baseline to 6-months

  90. Social support from friend - physical activity

    Friend social support for physical activity scale; 9-items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987

    Time frame: Change in social support from baseline to 12-months

  91. Social support from friend - physical activity

    Friend social support for physical activity scale; 9-items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987

    Time frame: Change in social support from baseline to 24-months

  92. Social support from friend - physical activity

    Friend social support for physical activity scale; 9-items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987

    Time frame: Change in social support from baseline to 36-months

  93. Social support from family - physical activity

    Family social support for physical activity scale; 15 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987

    Time frame: Change in social support from baseline to 6-months

  94. Social support from family - physical activity

    Family social support for physical activity scale; 15 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987

    Time frame: Change in social support from baseline to 12-months

  95. Social support from family - physical activity

    Family social support for physical activity scale; 15 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987

    Time frame: Change in social support from baseline to 24-months

  96. Social support from family - physical activity

    Family social support for physical activity scale; 15 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987

    Time frame: Change in social support from baseline to 36-months

  97. Outcome expectancies

    Outcome expectancies of behavior change; 25 items using 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicating greater outcome expectancy; Huttunen-Lenz et al., 2018

    Time frame: Change in outcome expectancies from baseline to 6-months

  98. Outcome expectancies

    Outcome expectancies of behavior change; 25 items using 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicating greater outcome expectancy; Huttunen-Lenz et al., 2018

    Time frame: Change in outcome expectancies from baseline to 12-months

  99. Outcome expectancies

    Outcome expectancies of behavior change; 25 items using 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicating greater outcome expectancy; Huttunen-Lenz et al., 2018

    Time frame: Change in outcome expectancies from baseline to 24-months

  100. Outcome expectancies

    Outcome expectancies of behavior change; 25 items using 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicating greater outcome expectancy; Huttunen-Lenz et al., 2018

    Time frame: Change in outcome expectancies from baseline to 36-months

  101. Coping self-efficacy

    Coping self-efficacy scale; 14 items using a 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicates greater self-efficacy for coping; Huttunen-Lenz et al., 2018

    Time frame: Change in coping self-efficacy from baseline to 6-months

  102. Coping self-efficacy

    Coping self-efficacy scale; 14 items using a 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicates greater self-efficacy for coping; Huttunen-Lenz et al., 2018

    Time frame: Change in coping self-efficacy from baseline to 12-months

  103. Coping self-efficacy

    Coping self-efficacy scale; 14 items using a 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicates greater self-efficacy for coping; Huttunen-Lenz et al., 2018

    Time frame: Change in coping self-efficacy from baseline to 24-months

  104. Coping self-efficacy

    Coping self-efficacy scale; 14 items using a 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicates greater self-efficacy for coping; Huttunen-Lenz et al., 2018

    Time frame: Change in coping self-efficacy from baseline to 36-months

Other outcomes

  1. Eligible DPP patients (reach)

    Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record

    Time frame: Baseline to 3-months

  2. Eligible DPP patients (reach)

    Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record

    Time frame: Baseline to 6-months

  3. Eligible DPP patients (reach)

    Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record

    Time frame: Baseline to 9-months

  4. Eligible DPP patients (reach)

    Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record

    Time frame: Baseline to 12-months

  5. Eligible DPP patients (reach)

    Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record

    Time frame: Baseline to 15-months

  6. Eligible DPP patients (reach)

    Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record

    Time frame: Baseline to 18-months

  7. Eligible DPP patients (reach)

    Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record

    Time frame: Baseline to 21-months

  8. Eligible DPP patients (reach)

    Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record

    Time frame: Baseline to 24-months

  9. Eligible DPP patients (reach)

    Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record

    Time frame: Baseline to 27-months

  10. Eligible DPP patients (reach)

    Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record

    Time frame: Baseline to 30-months

  11. Eligible DPP patients (reach)

    Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record

    Time frame: Baseline to 33-months

  12. Patients eligible for DPP (reach)

    Total number of patients in the ambulatory setting eligible for DPP; electronic health record

    Time frame: Baseline to 36-months

  13. Patients referred to DPP (reach)

    Total number of patients in the ambulatory setting referred to DPP; electronic health record

    Time frame: Baseline to 3-months

  14. Patients referred to DPP (reach)

    Total number of patients in the ambulatory setting referred to DPP; electronic health record

    Time frame: Baseline to 6-months

  15. Patients referred to DPP (reach)

    Total number of patients in the ambulatory setting referred to DPP; electronic health record

    Time frame: Baseline to 9-months

  16. Patients referred to DPP (reach)

    Total number of patients in the ambulatory setting referred to DPP; electronic health record

    Time frame: Baseline to 12-months

  17. Patients referred to DPP (reach)

    Total number of patients in the ambulatory setting referred to DPP; electronic health record

    Time frame: Baseline to 15-months

  18. Patients referred to DPP (reach)

    Total number of patients in the ambulatory setting referred to DPP; electronic health record

    Time frame: Baseline to 18-months

  19. Patients referred to DPP (reach)

    Total number of patients in the ambulatory setting referred to DPP; electronic health record

    Time frame: Baseline to 21-months

  20. Patients referred to DPP (reach)

    Total number of patients in the ambulatory setting referred to DPP; electronic health record

    Time frame: Baseline to 24-months

  21. Patients referred to DPP (reach)

    Total number of patients in the ambulatory setting referred to DPP; electronic health record

    Time frame: Baseline to 27-months

  22. Patients referred to DPP (reach)

    Total number of patients in the ambulatory setting referred to DPP; electronic health record

    Time frame: Baseline to 30-months

  23. Patients referred to DPP (reach)

    Total number of patients in the ambulatory setting referred to DPP; electronic health record

    Time frame: Baseline to 33-months

  24. Patients referred to DPP (reach)

    Total number of patients in the ambulatory setting referred to DPP; electronic health record

    Time frame: Baseline to 36-months

  25. Patients enrolled in DPP (reach)

    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record

    Time frame: Baseline to 3-months

  26. Patients enrolled in DPP (reach)

    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record

    Time frame: Baseline to 6-months

  27. Patients enrolled in DPP (reach)

    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record

    Time frame: Baseline to 9-months

  28. Patients enrolled in DPP (reach)

    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record

    Time frame: Baseline to 12-months

  29. Patients enrolled in DPP (reach)

    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record

    Time frame: Baseline to 15-months

  30. Patients enrolled in DPP (reach)

    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record

    Time frame: Baseline to 18-months

  31. Patients enrolled in DPP (reach)

    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record

    Time frame: Baseline to 21-months

  32. Patients enrolled in DPP (reach)

    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record

    Time frame: Baseline to 24-months

  33. Patients enrolled in DPP (reach)

    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record

    Time frame: Baseline to 27-months

  34. Patients enrolled in DPP (reach)

    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record

    Time frame: Baseline to 30-months

  35. Patients enrolled in DPP (reach)

    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record

    Time frame: Baseline to 33-months

  36. Patients enrolled in DPP (reach)

    Total number of patients in the ambulatory setting enrolled in DPP; electronic health record

    Time frame: Baseline to 36-months

  37. Referring clinical sites (adoption)

    Total number of clinical sites referring patients to the DPP, electronic health record

    Time frame: Baseline to 3-months

  38. Referring clinical sites (adoption)

    Total number of clinical sites referring patients to the DPP, electronic health record

    Time frame: Baseline to 6-months

  39. Referring clinical sites (adoption)

    Total number of clinical sites referring patients to the DPP, electronic health record

    Time frame: Baseline to 9-months

  40. Referring clinical sites (adoption)

    Total number of clinical sites referring patients to the DPP, electronic health record

    Time frame: Baseline to 12-months

  41. Referring clinical sites (adoption)

    Total number of clinical sites referring patients to the DPP, electronic health record

    Time frame: Baseline to 15-months

  42. Referring clinical sites (adoption)

    Total number of clinical sites referring patients to the DPP, electronic health record

    Time frame: Baseline to 18-months

  43. Referring clinical sites (adoption)

    Total number of clinical sites referring patients to the DPP, electronic health record

    Time frame: Baseline to 21-months

  44. Referring clinical sites (adoption)

    Total number of clinical sites referring patients to the DPP, electronic health record

    Time frame: Baseline to 24-months

  45. Referring clinical sites (adoption)

    Total number of clinical sites referring patients to the DPP, electronic health record

    Time frame: Baseline to 27-months

  46. Referring clinical sites (adoption)

    Total number of clinical sites referring patients to the DPP, electronic health record

    Time frame: Baseline to 30-months

  47. Referring clinical sites (adoption)

    Total number of clinical sites referring patients to the DPP, electronic health record

    Time frame: Baseline to 33-months

  48. Referring clinical sites (adoption)

    Total number of clinical sites referring patients to the DPP, electronic health record

    Time frame: Baseline to 36-months

  49. Referring providers (adoption)

    Total number of providers referring patients to the DPP; electronic health record

    Time frame: Baseline to 3-months

  50. Referring providers (adoption)

    Total number of providers referring patients to the DPP; electronic health record

    Time frame: Baseline to 6-months

  51. Referring providers (adoption)

    Total number of providers referring patients to the DPP; electronic health record

    Time frame: Baseline to 9-months

  52. Referring providers (adoption)

    Total number of providers referring patients to the DPP; electronic health record

    Time frame: Baseline to 12-months

  53. Referring providers (adoption)

    Total number of providers referring patients to the DPP; electronic health record

    Time frame: Baseline to 15-months

  54. Referring providers (adoption)

    Total number of providers referring patients to the DPP; electronic health record

    Time frame: Baseline to 18-months

  55. Referring providers (adoption)

    Total number of providers referring patients to the DPP; electronic health record

    Time frame: Baseline to 21-months

  56. Referring providers (adoption)

    Total number of providers referring patients to the DPP; electronic health record

    Time frame: Baseline to 24-months

  57. Referring providers (adoption)

    Total number of providers referring patients to the DPP; electronic health record

    Time frame: Baseline to 27-months

  58. Referring providers (adoption)

    Total number of providers referring patients to the DPP; electronic health record

    Time frame: Baseline to 30-months

  59. Referring providers (adoption)

    Total number of providers referring patients to the DPP; electronic health record

    Time frame: Baseline to 33-months

  60. Referring providers (adoption)

    Total number of providers referring patients to the DPP; electronic health record

    Time frame: Baseline to 36-months

  61. Implementation

    Qualitative assessment of implementation processes

    Time frame: Continuous processual evaluation

07

Study locations

1 site
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04822480
Lead sponsor
University of Mississippi Medical Center
Collaborators
American Medical Association, Mississippi State Department of Health
Responsible party
Abigail Gamble (Assistant Professor of Preventive Medicine and Population Health Science, University of Mississippi Medical Center) — Principal investigator
First posted
Mar 30, 2021
Start date
Feb 1, 2020
Primary completion
Dec 31, 2023
Completion
Dec 31, 2024 (estimated)
Last update
Apr 29, 2024

Study contacts

Abigail Gamble, PhD, MS
principal investigator · University of Mississippi Medical Center
Tamkeen Khan, PhD
principal investigator · American Medical Association

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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