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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: OHWL Clinic Activities (Standard of Care); Behavioral: Coach Activities

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan - East Ann Arbor Geriatrics Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study Participants

Behavioral: OHWL Clinic Activities (Standard of Care); 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.; Behavioral: Coach Activities; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants who attend physical therapy appointments	Patients who reported attending at least one physical therapy appointment during the course of the study, if referred.	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.	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.	6 months
Percentage of participants who achieve treatment goals	Percentage of participants whose coaches reported successful achievement of established goals for diet and physical therapy based on end of study interview.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PROMIS-29 Score (Patient-Reported Outcomes Measurement Information System)	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.	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	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. 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).	6 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.	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.	6 months, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2023
• Primary Completion (Actual): September 5, 2025
• Study Completion (Actual): March 17, 2026

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Aging; Health Coach
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: HUM00210504; P30AG024824 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No