Evaluation of Patient Coach Support for Older Adults With Obesity

Not Applicable

Active, not recruiting

• Conditions: Obesity
• Interventions: Behavioral: OHWL Clinic Activities (Standard of Care); Behavioral: Coach Activities

• Registration Number: NCT06624163
• Lead Sponsor: University of Michigan

Brief 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. 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.

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.

Study Timeline

• Study Start: 2023-06-08
• Study First Submitted: 2024-09-26
• Study First Submitted QC: 2024-09-30
• Study First Posted: 2024-10-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-09
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Participants	Coach Activities	-
Study Participants	OHWL Clinic Activities (Standard of Care)	-

Primary Outcome Measures

Name	Time	Method
Percentage of participants who attend physical therapy appointments	6 months	Patients who reported attending at least one physical therapy appointment during the course of the study, if referred.
Percentage of participants who achieve treatment goals	6 months	Percentage of participants whose coaches reported successful achievement of established goals for diet and physical therapy based on end of study interview.
Percentage of participants who attend nutritional consultation appointments	6 months	Patients who reported attending at least one nutritional consultation appointment during the course of the study.
Percentage of participants who access community resources	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 Outcome Measures

Name	Time	Method
Change in reported participant pain levels	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
Change in PROMIS-29 Score (Patient-Reported Outcomes Measurement Information System)	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.
Change in NHATS (National health and aging trends study) Score	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).
Change in patient mobility	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.
Change in Life Space Assessment Score	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.

Trial Locations

Locations (1)

University of Michigan - East Ann Arbor Geriatrics Center; 🇺🇸 Ann Arbor, Michigan, United States