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Completed

NCT Number: NCT06915090

FIT-COACH: Fitbit Intervention With Coordinated Health Coaching and PCP Support

In individuals with overweight/obesity, increases in physical activity (PA) can improve metabolic and cardiovascular health, independent of weight loss. However, PA levels are often low in individuals with overweight/obesity, and primary care providers (PCPs) are tasked with addressing this issue. The investigative team developed and successfully piloted integrating a Fitbit program into clinical care, where patients were referred by PCPs, and PCPs could view PA data in the Epic electronic health record. Though feasible, PCPs wanted additional support for PA management. We also acknowledge the role of pharmacotherapy (GLP-1 agonists and GIPs) in clinical care for patients with overweighr and obesity, and the added support these patients may need. The investigative team proposes a reimbursable service of a health coach to work collaboratively with PCPs, to deliver a Fitbit-supported PA program to patients with overweight/obesity who have been prescribed a weight loss medication. In Aim 1, the team will enroll PCPs to refer patients to a 12-week health coaching program. In Aim 2, the team will conduct interviews with enrolled patients/PCPs to understand their perspectives on the program, and with new sites to establish relationships for a future R01 submission.

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Key information

Conditions

GLP - 1 Behavior Body Weight Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity and Obesity-related Medical Conditions Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Chan Medical School

Worcester, Massachusetts, 01605, United States

About this study

In Aim 1, after the patient has signed consent with the study coordinator, the coordinator will schedule the patient for their baseline in-person visit, and a flowsheet for the fitness tracker will be placed in the EHR by the study clinicians. During the baseline visit, the study team will assess height and weight, waist circumference assessment, and body composition. The 3-month follow-up visit will include the same measurements as listed above. Once baseline measures are completed, patients without a Fitbit device will be provided one for the duration of the study, which they get to keep. The same option will be available for patients who already have a Fitbit but would like one provided by the study team anyway. Patients will also install the Fitbit application and MyChart application (if needed) and sync the Fitbit with their patient portal with direction from the study team. Participants will also be instructed to wear their Fitbit for a total of 12 weeks. They will be provided a suggested step count to be accomplished from the health coach once they meet for the first session

Patients will have their first meeting scheduled with the health coach (up to 60-minutes in length, remotely). Patients will then meet with the health coach up to 5 more times (remotely) for up to 30-minutes per session over the course of the 12 weeks in the study. Health coaches will schedule meetings with the patients and communicate via Mychart. All sessions will be telehealth, conducted and recorded over Zoom. Patients will participate in the study for up to 12 weeks. Patients will receive support from the study team during the study period to troubleshoot any device related issue.

In Aim 2, patients and providers will provide verbal consent and be interviewed by the study research coordinator to assess workflow acceptability, perceptions, areas for workflow modification, preferences for initial training, preferences for frequency of review of remote monitoring data, and health coach interactions. The study team will interview patients during and at the completion of their 12 weeks to understand their perceptions on the program and supports needed, such as activity goals, feedback etc. Interviews will be 30-minutes in length, audio recorded only.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI ≥27-45
  • Prescribed a GLP-1/GIP within the past 6 months
  • Currently taking GLP/GIP
  • Age 18 years of age and older
  • Patient of UMass Medical Group Primary Care Clinic
  • Speaks and reads English

Exclusion criteria

  • BMI <27 or ≥45
  • Not currently taking GLP-1/GIP
  • Under 18 years of age
  • Prescribed GLP-1/GIP for less than 6 months
  • Not a patient of UMass Medical Group Primary Care Clinic
  • Does not speak English

Treatment and study plan

Health Coach/Fitbit

Behavioral

Health coach visits (up to 6) will be conducted virtually and include:

Session 1:

  • Assessment, wellness vision,
  • Habits and goals (Stretching, strength training, cardiovascular PA/walking, Diet)
  • Motivation, resources, and guidelines
  • Online program orientation
  • Set first week's goals

Sessions 2-5:

-Goal review, successes and challenges, new goal setting (i.e. Increase steps by 1,000/day if consistently meeting goal)

Session 6

-Review of progress, maintenance plan, final assessment

Primary outcomes

  1. Feasibility of enrollment

    Time frame: 6-months

    The number of enrolled patients in the study.

Secondary outcomes

  1. Engagement with intervention

    Time frame: 3-months

    The proportion of scheduled visits the patient completes with the health coach over the 3-month study.

  2. Average steps per day

    Time frame: Baseline, 3-months

    The average steps per day over the course of 1-week.

  3. Short-Form 12 Question Health-related Quality of Life

    Time frame: Baseline, 3-months

    12-item self-report survey assessing quality of life. Scores range from 0-100 with a higher score indicating more positive health-related quality of life.

  4. Numeric Pain Rating Scale (NPRS)

    Time frame: Baseline, 3-months

    6-questions regarding pain in body parts and doing activities of daily living using a Likert Scale from 0 to 10. Scores range from 0 (minimum) to 50 (maximum) with higher scores indicating greater levels of pain.

  5. Muscle Strengthening Activities

    Time frame: Baseline, 3-months

    The Muscle-Strengthening Exercise Questionnaire (MSEQ) is a 4-item questionnaire assessing the weekly frequency, session duration and intensity, types of MSE (e.g., weight machines, bodyweight exercise) and muscle groups targeted. Scores range from 0 (minimum) to 7 (maximum), with higher scores indicating higher frequency of muscle strengthening activities.

  6. Short-form Dietary Recall

    Time frame: Baseline, 3-months

    A short-form 15-item Food Frequency Questionnaire (FFQ) is a dietary assessment tool designed to estimate an individual's usual intake of specific food groups over a given period. The scores range from 15 (minimum) to 75 (maximum), with higher scores indicating consumption of a healthier diet.

  7. Self-Report Physical Activity (IPAQ-SF)

    Time frame: Baseline, 3-months

    The Physical Activity Questionnaire - Short Form (PAQ-SF) is a brief, self-reported questionnaire designed to assess an individual's physical activity levels over a specified period, typically the past 7 days. It is a condensed version of longer physical activity questionnaires, making it practical for use in research, clinical settings, and population health surveys. The minimum score is 0 (no minutes per week), and there is no maximum. Higher scores indicate higher levels of physical activity.

  8. Exercise Self Efficacy

    Time frame: Baseline, 3-months

    A 24-item tool assessing barriers that get in the way of physical activity on a Likert scale of 1 to 5. The scores range from 24 (minimum) to 168 (maximum) with a higher score indicating greater exercise self-efficacy.

  9. Eating Self-Efficacy Brief Scale

    Time frame: Baseline, 3-months

    Designed to assess an individual's confidence in their ability to control eating behaviors across different situations. It is rooted in self-efficacy theory, which emphasizes the role of belief in one's capability to perform specific behaviors. Consists of 7 items using a Likert scale of 1 to 5 for responses. The total score range is 10 (minimum) to 70 (maximum), with a higher score indicating greater eating self-efficacy.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Acronym: FIT-COACH

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2025
Registry last updated
Dec 18, 2025

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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