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Completed

NCT Number: NCT06624163

Evaluation of Patient Coach Support for Older Adults With Obesity

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.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan - East Ann Arbor Geriatrics Center

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Active mental health disorder, such as major depression
  • Moderate to severe cognitive impairment
  • Mobility limited to bed-bound status

Treatment and study plan

OHWL Clinic Activities (Standard of Care)

Behavioral

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 Activities

Behavioral

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.

Primary outcomes

  1. Percentage of participants who attend physical therapy appointments

    Time frame: 6 months

    Patients who reported attending at least one physical therapy appointment during the course of the study, if referred.

  2. Percentage of participants who achieve treatment goals

    Time frame: 6 months

    Percentage of participants whose coaches reported successful achievement of established goals for diet and physical therapy based on end of study interview.

  3. Percentage of participants who attend nutritional consultation appointments

    Time frame: 6 months

    Patients who reported attending at least one nutritional consultation appointment during the course of the study.

  4. Percentage of participants who access community resources

    Time frame: 6 months

    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.

Secondary outcomes

  1. Change in PROMIS-29 Score (Patient-Reported Outcomes Measurement Information System)

    Time frame: 6 months

    PROMIS 29 questionnaire gauges health-related quality of life across seven key domains: physical function, pain interference, fatigue, sleep disturbance, physical and mental health, and social health. Each item is auto-scored and T-score is obtained for each domain and will be tracked during the study time frame

    Scores range from 0 to 100, where a score of 0 indicates lowest quality of life and 100 indicates highest quality of life.

  2. Change in reported participant pain levels

    Time frame: 6 months

    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

  3. Change in NHATS (National health and aging trends study) Score

    Time frame: 6 months

    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. Each domain has multiple questions with responses such as (Yes/No) for most; (None, little, some, Lot); (Always did it by self, together with someone else, someone always did it, it varied, not done in the last month); (everyday, most days, some days, rarely, never); (every time, most times, sometimes, rarely).

  4. Change in patient mobility

    Time frame: 6 months, 12 months

    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.

  5. Change in Life Space Assessment Score

    Time frame: 6 months

    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.

Other outcomes

  1. NUTRITION assessment by ASA24 food recall - fat

    Time frame: 6 months

    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.

  2. NUTRITION assessment by ASA24 food recall - kilocalories

    Time frame: 6 months

    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.

  3. NUTRITION assessment by ASA24 food recall - saturated fat

    Time frame: 6 months

    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.

  4. NUTRITION assessment by ASA24 food recall - sodium

    Time frame: 6 months

    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.

  5. NUTRITION assessment by ASA24 food recall - added sugar

    Time frame: 6 months

    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.

  6. NUTRITION assessment by ASA24 food recall - alcohol

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 2, 2024
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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