An interventional study of Standard Lifestyle Advice and Advice Plus Lifestyle Intervention in Diabetes Mellitus, Hyperglycemia and Obesity, sponsored by Northwestern University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-27.
Sponsored by Northwestern University · Not applicable, Interventional, and Supportive care
The purpose of this study is to compare ways of giving advice and providing support to improve diet and physical activity in adult primary care patients with elevated body mass index and dysglycemia.
This is a randomized comparative effectiveness trial to evaluate the health and economic effects of a community-based intensive lifestyle intervention for adult primary care patients with elevated body mass index and dysglycemia (either type 2 diabetes or pre-diabetes). The study will use qualitative and quantitative methods to assess reach, effectiveness, costs, adoption, implementation, and maintenance of a clinical-community partnership to offer intensive lifestyle intervention resources to eligible adult primary care patients.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's enrollment of 331 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria (any of the following):
Diseases/Conditions that could limit lifespan and/or increase risk with a lifestyle intervention:
Significant cardiovascular disease:
Lung disease:
Exclusions related to metabolism:
Exclusion for conditions or behaviors likely to affect the conduct of the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).
Behavioral: Standard Lifestyle Advice
Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.
Behavioral: Standard Lifestyle Advice · Behavioral: Advice Plus Lifestyle Intervention
Standard clinical education is offered routinely by the participant's usual primary care team. Primary care teams receive educational outreach visits and are provided with clinical recommendations for lifestyle and cardiovascular risk factor management. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months.
Also known as: Brief Lifestyle Advice
Standard clinical education offered routinely by the participant's usual primary care team. Primary care teams receive educational outreach visits for lifestyle and cardiovascular risk factor management. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team.
Also known as: Plan Ahead Lifestyle Intervention, Intensive Lifestyle Intervention
Percent Change in Body Weight
(Body weight at 12 months subtracted from baseline body weight) divided by baseline body weight. Negative numbers indicate a weight loss.
Time frame: Baseline to 12 months
Incremental Costs
The study will capture direct medical, direct non-medical, and indirect costs from individual participants. Mean changes in these costs will be compared across randomized study arms.
Time frame: 6, 12, and 24 months
Changes in Health State Utility
The study collects individual participant survey data that will include the Medical Outcomes Study Short Form-12 health-related quality of life questionnaire. Responses from the questionnaire are used to construct a validated numerical score that expresses global health-related quality of life across a range of 0 (death) to 1 (perfect health). Changes in this indicator will be evaluated.
Time frame: Baseline to 6,12, and 24 months
Percent Change in Body Weight
Time frame: Baseline to 6 and 24 months
Percent Change in Blood Total Cholesterol
Time frame: Baseline to 6, 12, and 24 months
Percent Change in A1c
Time frame: Baseline to 6, 12, and 24 months
Percent Change in Blood Pressure
Time frame: Baseline to 6, 12, and 24 months
Percent Change in Dietary Composition
Time frame: Baseline to 6, 12, and 24 months
Percent Change in Physical Activity
Time frame: Baseline to 6, 12, and 24 months
| Milestone | Standard Lifestyle Advice | Advice Plus Lifestyle Intervention |
|---|---|---|
| Started | 167 | 164 |
| Completed | 128 | 129 |
| Not completed | 39 | 35 |
(Body weight at 12 months subtracted from baseline body weight) divided by baseline body weight. Negative numbers indicate a weight loss.
| percentage of change | Standard Lifestyle Advice | Advice Plus Lifestyle Intervention |
|---|---|---|
| Percent Change in Body Weight | -0.15 ± 4.05 | -1.42 ± 4.45 |
The study will capture direct medical, direct non-medical, and indirect costs from individual participants. Mean changes in these costs will be compared across randomized study arms.
Results for this outcome have not been posted.
The study collects individual participant survey data that will include the Medical Outcomes Study Short Form-12 health-related quality of life questionnaire. Responses from the questionnaire are used to construct a validated numerical score that expresses global health-related quality of life across a range of 0 (death) to 1 (perfect health). Changes in this indicator will be evaluated.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Lifestyle Advice | 1/167 (0.6%) | 10/167 (6%) | 0/167 (0%) |
| Advice Plus Lifestyle Intervention | 0/164 (0%) | 10/164 (6.1%) | 0/164 (0%) |
| Event | Standard Lifestyle Advice | Advice Plus Lifestyle Intervention |
|---|---|---|
| Hypoglycemia (severe: admitted to hospital, emergency room, or needed assistance by other person)Endocrine disorders | 4/167 | 4/164 |
| Balloon angioplasty or Stenting of coronary arteries (Percutaneous transluminal coronary angioplastySurgical and medical procedures | 2/167 | 3/164 |
| FractureInjury, poisoning and procedural complications | 3/167 | 2/164 |
| Heart attack (myocardial infarction)Cardiac disorders | 1/167 | 1/164 |
| Congestive Heart FailureCardiac disorders | 1/167 | 1/164 |
| Stroke (transient ischemic attack, cerebral ischemia/hemorrhage, or cerebrovascular accident)Nervous system disorders | 1/167 | 1/164 |
| Cardiac Arryhythmia (atrial fibrillation or flutter)Cardiac disorders | 0/167 | 0/164 |
| Age, Categorical(Participants) | Standard Lifestyle Advice | Advice Plus Lifestyle Intervention | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 124 | 125 | 249 |
| >=65 years | 43 | 39 | 82 |
| Age, Continuous(years) | Standard Lifestyle Advice | Advice Plus Lifestyle Intervention | Total |
|---|---|---|---|
| Mean | 56.6 ± 12.2 | 57.1 ± 10.6 | 56.9 ± 11.4 |
| Sex: Female, Male(Participants) | Standard Lifestyle Advice | Advice Plus Lifestyle Intervention | Total |
|---|---|---|---|
| Female | 81 | 85 | 166 |
| Male | 86 | 79 | 165 |
| Ethnicity (NIH/OMB)(Participants) | Standard Lifestyle Advice | Advice Plus Lifestyle Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | 43 | 48 | 91 |
| Not Hispanic or Latino | 124 | 116 | 240 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Standard Lifestyle Advice | Advice Plus Lifestyle Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 9 | 6 | 15 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 54 | 50 | 104 |
| White | 63 | 62 | 125 |
| More than one race | 4 | 2 | 6 |
| Unknown or Not Reported | 37 | 44 | 81 |
| Region of Enrollment(participants) | Standard Lifestyle Advice | Advice Plus Lifestyle Intervention | Total |
|---|---|---|---|
| United States | 167 | 164 | 331 |
Plan to share: No
The record gives a start of Aug 2011, a primary completion of Sep 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2018, 1 year 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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