Evaluation of Patient Coach Support for Older Adults With Obesity

NCT06624163 | Completed

• 2 other identifiers: HUM00210504P30AG024824
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Health Coach; Aging

Outcome Measures

Primary Outcomes (4)

• 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 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

• 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

Secondary Outcomes (5)

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

  6 months

• Change in reported participant pain levels

  6 months

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

  6 months

• Change in patient mobility

  6 months, 12 months

• Change in Life Space Assessment Score

  6 months

Other Outcomes (6)

• NUTRITION assessment by ASA24 food recall - fat

  6 months

• NUTRITION assessment by ASA24 food recall - kilocalories

  6 months

• NUTRITION assessment by ASA24 food recall - saturated fat

  6 months

Study Arms (1)

Study Participants

EXPERIMENTAL

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

Interventions

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.

Study Participants

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.

Study Participants

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Michigan - East Ann Arbor Geriatrics Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 2, 2024
• Study Start: June 8, 2023
• Primary Completion: September 5, 2025
• Study Completion: March 17, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

US (1)