An interventional study of OHWL Clinic Activities (Standard of Care) and Coach Activities in Obesity, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University of Michigan · Not applicable, Interventional, and Supportive care
The purpose of the present pilot is to evaluate the outcomes of adding a patient coach to support the Optimal Health Weight and Lifestyle (OHWL) Clinic plan developed by PI Dewar, specifically to address barriers and facilitators of adherence to the plan. This will be accomplished via a coach who is not embedded in clinic care and is supported by pilot research funds. Evaluation of the coach activities, conducted by research personnel, will include compiling data from the electronic health record, a short set of patient report and performance measures, and qualitative interviews.
A patient coach added to the OHWL Clinic plan as part of the pilot will help patients who are being treated for weight loss to achieve their goals, help address barriers and facilitators of adherence to referred services such physical therapy and nutritionist appointments and various specialists and links to community services as needed. Evaluation of the coach activities will be conducted by research personnel, which will also include data compilation from the electronic health record, a short set of patient report and performance measures, and qualitative interviews. This project will provide pilot data for future funding proposals.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 19 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: OHWL Clinic Activities (Standard of Care) · Behavioral: Coach Activities
Following a directed history and physical at the initial visit, the OHWL Care provider (OCP) develops a medical and weight management plan, which includes laboratory testing (such as for Hemoglobin A1C (HbA1c), consultant referrals (e.g. sleep, heart failure clinics) and referral to nutritionists and physical therapy (PT). The OCP begins the process of establishing patient goals, which will be followed up by the coach. The OCP reviews patient progress with the goals during face-to-face visits (some by telehealth) at two, four and six months. As part of the standard initial clinic evaluation, a medical assistant evaluates grip strength (using a hand dynamometer) the timed up and go mobility test; these are repeated at the 6-month visit.
A patient coach follows patients outside of clinic to ensure adherence with referral appointments and use of recommended community services. The coach assesses the participant at baseline, 3 months, and 6 months using the Patient-Specific Functional Scale and follows up with patients via phone over 6 months. The coach utilizes S.M.A.R.T. (Specific, Measurable, Achievable, Relevant, Time-bound) goals to facilitate, for example, transportation, barriers to scheduling, etc. The coach follows up on specialist referral recommendations, physical therapy, and nutrition program, as well as social work recommendations. Barriers and facilitators to program adherence are identified and addressed.
Participants' Physical Therapy Appointments
Patients who reported being referred to physical therapy during or before the study and attended at least one physical therapy appointment during the course of the study.
Time frame: 6 months
Percentage of Participants Who Achieve Treatment Goals
Percentage of participants whose coaches reported successful completion of at least one goal for diet and physical activity based on end of study interview.
Time frame: 6 months
Percentage of Participants Who Attend Nutritional Consultation Appointments
Patients who reported attending at least one nutritional consultation appointment during the course of the study, as determined by medical record review.
Time frame: 6 months
Percentage of Participants Who Access Community Resources
Patients who reported using a community resource (such as a gym, community park, or other similar resource) at least once during the course of the study.
Time frame: 6 months
Change in PROMIS-28 Score (Patient-Reported Outcomes Measurement Information System)
PROMIS-28 questionnaire gauges health-related quality of life across seven key domains: physical function, anxiety, depression, fatigue, ability to engage in social activities, pain interference, sleep disturbance. Total scores range from 27 - 140, where a score of 27 indicates lowest quality of life and 140 indicates highest quality of life.
Time frame: Baseline, 6 months
Change in Reported Participant Pain Levels
This is assessed by PROMIS-Global Pain instrument which is a survey administered to patient by Computer adaptive testing, Scale 0-10 (where 0 is no pain and 10 is worst pain imaginable) and will track change during study period
Time frame: Baseline, 6 months
Change in NHATS (National Health and Aging Trends Study) Score
NHATS instrument scores individual's self-report of difficulty or dependency with performing activities of daily living such as self-care and mobility and restrictions in instrumental activities of daily living domains. The final survey instrument score is on a scale of 1-4, with 1 being "no difficulty" with performing activities of daily living and 4 being "a lot of difficulty" with performing activities of daily living.
Time frame: 6 months
Change in Patient Mobility
Mobility and balance is measured during clinic visits using TUG (Timed up and go). The patient is asked to rise from a seated position, walk 3 m, turn around, and return and sit in the starting point chair while timed. Patients who fail to complete the test in fewer than 12 s are considered to have elevated fall risk Measurements will be taken every six months.
Time frame: Baseline, 6 months, 12 months
Change in Life Space Assessment Score
Life-space mobility is a measure of resilience to physical decline and social isolation in older adults. They are nine 'yes/no' questions regarding a person's movements across nine life-space zones in the preceding 3 days. The total score ranges from 0 to 9, where 0 means most restricted life-space and 9 is least restricted life-space.
Time frame: Baseline, 6 months
NUTRITION Assessment by ASA24 Food Recall - Fat
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls. Participants are asked to report everything they ate or drank over the last 24-hours by using an online tool. Data collected on enrollment and 3 months and at 6 months. Intake of grams fat will be tracked to see changes over the study period.
Time frame: 6 months
NUTRITION Assessment by ASA24 Food Recall - Kilocalories
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls. Participants are asked to report everything they ate or drank over the last 24-hours by using an online tool. Data collected on enrollment and 3 months and at 6 months. Intake of total kilocalories will be tracked to see changes over the study period.
Time frame: 6 months
NUTRITION Assessment by ASA24 Food Recall - Saturated Fat
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls. Participants are asked to report everything they ate or drank over the last 24-hours by using an online tool. Data collected on enrollment and 3 months and at 6 months. Intake of grams saturated fat will be tracked to see changes over the study period.
Time frame: 6 months
NUTRITION Assessment by ASA24 Food Recall - Sodium
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls. Participants are asked to report everything they ate or drank over the last 24-hours by using an online tool. Data collected on enrollment and 3 months and at 6 months. Intake of milligrams sodium will be tracked to see changes over the study period.
Time frame: 6 months
NUTRITION Assessment by ASA24 Food Recall - Added Sugar
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls. Participants are asked to report everything they ate or drank over the last 24-hours by using an online tool. Data collected on enrollment and 3 months and at 6 months. Intake of grams of added sugar will be tracked to see changes over the study period.
Time frame: 6 months
NUTRITION Assessment by ASA24 Food Recall - Alcohol
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls. Participants are asked to report everything they ate or drank over the last 24-hours by using an online tool. Data collected on enrollment and 3 months and at 6 months. Intake of grams of alcohol will be tracked to see changes over the study period.
Time frame: 6 months
HbA1c Values
HbA1c values reflects glycemic control. Lower values reflect greater glycemic control
Time frame: Baseline, 6 months, 12 months
Total Cholesterol
Total cholesterol at baseline, 6 months, and 12 months
Time frame: Baseline, 6 months, and 12 months
Triglycerides
Triglycerides at baseline, 6 months, and 12 months
Time frame: Baseline, 6 months, and 12 months
LDL Values
LDL values at baseline, 6 months, and 12 months
Time frame: Baseline, 6 months, and 12 months
HDL Levels
HDL levels at baseline, 6 months, and 12 months
Time frame: Baseline, 6 months, and 12 months
| Milestone | Study Participants |
|---|---|
| Started | 19 |
| Attended at least one coach appointment | 19 |
| Completed | 17 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Lost to follow-up | 1 |
Patients who reported being referred to physical therapy during or before the study and attended at least one physical therapy appointment during the course of the study.
| Participants | Study Participants |
|---|---|
| Participants referred to Physical Therapy | 6 |
| Participants who attended at least one Physical Therapy appointment | 2 |
Percentage of participants whose coaches reported successful completion of at least one goal for diet and physical activity based on end of study interview.
| Participants | Study Participants |
|---|---|
| Percentage of Participants Who Achieve Treatment Goals | 18 |
Patients who reported attending at least one nutritional consultation appointment during the course of the study, as determined by medical record review.
| Participants | Study Participants |
|---|---|
| Percentage of Participants Who Attend Nutritional Consultation Appointments | 17 |
Patients who reported using a community resource (such as a gym, community park, or other similar resource) at least once during the course of the study.
| Participants | Study Participants |
|---|---|
| Percentage of Participants Who Access Community Resources | 10 |
PROMIS-28 questionnaire gauges health-related quality of life across seven key domains: physical function, anxiety, depression, fatigue, ability to engage in social activities, pain interference, sleep disturbance. Total scores range from 27 - 140, where a score of 27 indicates lowest quality of life and 140 indicates highest quality of life.
| score on a scale | Study Participants |
|---|---|
| Baseline | 103.9 ± 21.2 |
| 6 months | 116.3 ± 13.8 |
This is assessed by PROMIS-Global Pain instrument which is a survey administered to patient by Computer adaptive testing, Scale 0-10 (where 0 is no pain and 10 is worst pain imaginable) and will track change during study period
| score on a scale | Study Participants |
|---|---|
| Baseline | 4.1 ± 2.2 |
| 6 Months | 3.2 ± 2.0 |
NHATS instrument scores individual's self-report of difficulty or dependency with performing activities of daily living such as self-care and mobility and restrictions in instrumental activities of daily living domains. The final survey instrument score is on a scale of 1-4, with 1 being "no difficulty" with performing activities of daily living and 4 being "a lot of difficulty" with performing activities of daily living.
| score on a scale | Study Participants |
|---|---|
| Baseline | 1.3164 ± 0.36695 |
| 6 months | 1.0485 ± 0.07652 |
Mobility and balance is measured during clinic visits using TUG (Timed up and go). The patient is asked to rise from a seated position, walk 3 m, turn around, and return and sit in the starting point chair while timed. Patients who fail to complete the test in fewer than 12 s are considered to have elevated fall risk Measurements will be taken every six months.
| seconds | Study Participants |
|---|---|
| Baseline | 18.9 ± 9.1 |
| 6 months | 14.6 ± 4.9 |
| 12 months | 47.5 ± 7.8 |
Life-space mobility is a measure of resilience to physical decline and social isolation in older adults. They are nine 'yes/no' questions regarding a person's movements across nine life-space zones in the preceding 3 days. The total score ranges from 0 to 9, where 0 means most restricted life-space and 9 is least restricted life-space.
| score on a scale | Study Participants |
|---|---|
| Baseline | 7 ± 1.6 |
| 6 months | 3 ± 1.45 |
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls. Participants are asked to report everything they ate or drank over the last 24-hours by using an online tool. Data collected on enrollment and 3 months and at 6 months. Intake of grams fat will be tracked to see changes over the study period.
Results for this outcome have not been posted.
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls. Participants are asked to report everything they ate or drank over the last 24-hours by using an online tool. Data collected on enrollment and 3 months and at 6 months. Intake of total kilocalories will be tracked to see changes over the study period.
Results for this outcome have not been posted.
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls. Participants are asked to report everything they ate or drank over the last 24-hours by using an online tool. Data collected on enrollment and 3 months and at 6 months. Intake of grams saturated fat will be tracked to see changes over the study period.
Results for this outcome have not been posted.
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls. Participants are asked to report everything they ate or drank over the last 24-hours by using an online tool. Data collected on enrollment and 3 months and at 6 months. Intake of milligrams sodium will be tracked to see changes over the study period.
Results for this outcome have not been posted.
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls. Participants are asked to report everything they ate or drank over the last 24-hours by using an online tool. Data collected on enrollment and 3 months and at 6 months. Intake of grams of added sugar will be tracked to see changes over the study period.
Results for this outcome have not been posted.
The Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls. Participants are asked to report everything they ate or drank over the last 24-hours by using an online tool. Data collected on enrollment and 3 months and at 6 months. Intake of grams of alcohol will be tracked to see changes over the study period.
Results for this outcome have not been posted.
HbA1c values reflects glycemic control. Lower values reflect greater glycemic control
Results for this outcome have not been posted.
Total cholesterol at baseline, 6 months, and 12 months
Results for this outcome have not been posted.
Triglycerides at baseline, 6 months, and 12 months
Results for this outcome have not been posted.
LDL values at baseline, 6 months, and 12 months
Results for this outcome have not been posted.
HDL levels at baseline, 6 months, and 12 months
Results for this outcome have not been posted.
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Participants | 0/19 (0%) | 1/19 (5.3%) | 8/19 (42.1%) |
| Event | Study Participants |
|---|---|
| Shoulder injury due to fallInjury, poisoning and procedural complications | 1/19 |
| Event | Study Participants |
|---|---|
| ConstipationGastrointestinal disorders | 5/19 |
| Acid RefluxGastrointestinal disorders | 2/19 |
| Nausea/VomitingGastrointestinal disorders | 1/19 |
| IndigestionGastrointestinal disorders | 1/19 |
| Hair LossSkin and subcutaneous tissue disorders | 1/19 |
| Age, Continuous(years) | Study Participants |
|---|---|
| Mean | 74.67 ± 5.686 |
| Sex: Female, Male(Participants) | Study Participants |
|---|---|
| Female | 15 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Study Participants |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 17 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 14 |
| More than one race | 1 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | Study Participants |
|---|---|
| United States | 19 |
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