ObesityNCT06624163
Evaluation of Patient Coach Support for Older Adults With Obesity
A study testing Coach Activities in people with Obesity, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Obesity
- What is being tested?
- Coach Activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2023to 17 Mar 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) equal to or greater than 35
- Ability to walk across a room with or without an assistive device
- Willingness and ability to follow instructions
- Interest in weight management
- At least two of the following conditions: hypertension, cardiovascular conditions including heart failure, diabetes mellitus, hyperlipidemia, non-alcoholic steatohepatitis, obstructive sleep apnea, osteoarthritis
Who cannot join
- Active mental health disorder, such as major depression
- Moderate to severe cognitive impairment
- Mobility limited to bed-bound status
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan - East Ann Arbor Geriatrics Center
Ann Arbor, Michigan, 48109
About this study
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.
Read the detailed description
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.
- Conditions
- Obesity
- Being tested
- OHWL Clinic Activities (Standard of Care), Coach Activities
- Keywords
- Health Coach, Aging
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OHWL Clinic Activities (Standard of Care)Behavioural
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.
Coach ActivitiesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Participants | Experimental | Not described Receives: Behavioral: OHWL Clinic Activities (Standard of Care); Behavioral: Coach Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start8 Jun 2023
- Primary completion5 Sep 2025
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Shenbagam Dewar, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624163
- Sponsor's protocol ID
- HUM00210504
- Other IDs
- P30AG024824
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2024
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No