Fitbit-Supported Health Coaching for Obesity

(FIT-COACH Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Massachusetts, Worcester

Must be taking: GLP-1/GIP

Disqualifiers: Type 2 diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you continue taking a GLP-1/GIP medication for at least 3 months.

What data supports the effectiveness of the treatment Health Coach/Fitbit for obesity?

Research shows that health coaching, especially when participants engage in multiple sessions, can lead to modest weight loss and improvements in physical activity and metabolic health. Programs that include health coaching have been effective in helping people lose weight and maintain healthier lifestyles. ^{1 2 3 4 5}

Is Fitbit-supported health coaching safe for humans?

The available research on health coaching, including programs using technology like telemedicine and telephone, suggests that these interventions are generally safe for humans. They have been used in various settings and populations without reported safety concerns. ^{1 3 5 6 7}

How does the Fitbit-supported health coaching treatment for obesity differ from other treatments?

This treatment is unique because it combines personalized health coaching with the use of Fitbit activity trackers, which provide real-time feedback and motivation to increase physical activity. Unlike traditional methods, it leverages technology to enhance accessibility and engagement, making it a cost-effective and innovative approach to managing obesity. ^{1 8 9 10 11}

What is the purpose of this trial?

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. 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 for weight loss for a minimum of 3 months. 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.

Eligibility Criteria

This trial is for individuals with overweight/obesity who have been prescribed weight loss medication for at least 3 months. It aims to help them increase physical activity through a program that includes a Fitbit device and support from health coaches, in coordination with primary care providers.

Inclusion Criteria

I have been prescribed a GLP-1/GIP medication in the last 3 months.

BMI ≥27-40

Patient of UMass Medical Group Primary Care Clinic

Exclusion Criteria

Not a patient of UMass Medical Group Primary Care Clinic

I am not taking any GLP-1/GIP medication.

I have been taking GLP-1/GIP medication for under 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including height, weight, and waist circumference measurements. Optional body composition analysis is conducted.

1 day

1 visit (in-person)

Treatment

Participants receive a Fitbit device and engage in a 12-week health coaching program with up to 6 virtual sessions.

12 weeks

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including interviews to assess program perceptions.

4 weeks

1 visit (in-person), interviews (virtual)

Treatment Details

Interventions

• Health Coach/Fitbit

Trial Overview The FIT-COACH trial tests whether a Fitbit-supported physical activity program, combined with health coaching and PCP oversight, can improve metabolic and cardiovascular health in patients with obesity-related conditions like diabetes.

Participant Groups

Group I: GLP-1/Coaching Arm Experimental Treatment 1 Intervention

Patients enrolled in this arm will complete assessments at baseline and 3-months, and receive a 12-week health coaching intervention (up to 6 virtual sessions with health coach) in addition to a Fitbit wearable device.

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Findings from Research

Health coaching delivered through videoconferencing (VC) resulted in significantly greater weight loss (8.23 kg) and increased physical activity (steps/day) compared to in-person coaching and a control group over a 12-week period, indicating its efficacy for adults with high BMI.

The VC group also showed a significant decrease in insulin resistance (HOMA-IR), suggesting that this method of health coaching can lead to improved metabolic health, while no significant changes were observed in glucose or HbA1c levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine-Based Health Coaching Is Effective for Inducing Weight Loss and Improving Metabolic Markers. Johnson, KE., Alencar, MK., Coakley, KE., et al.[2023]

In a study of 225 participants in a telephonic health coaching program, those who engaged in at least 6 coaching sessions experienced a significant average weight loss of -3.5%, compared to a modest overall weight change of -2.1% for the group.

Despite the focus on weight management, the study found no significant changes in healthcare utilization or costs associated with program engagement, suggesting that while coaching can aid weight loss, it may not impact healthcare visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating an insurer-based health coaching program: Impact of program engagement on healthcare utilization and weight loss. Reid, N., Bennett, W., Coughlin, J., et al.[2020]

Participants in the Get Healthy Information and Coaching Service (GHS) maintained significant improvements in weight, waist circumference, and BMI six months after completing a 6-month coaching program, indicating the program's effectiveness in promoting long-term lifestyle changes.

While improvements in fruit and vegetable consumption were sustained, the increase in physical activity levels observed at the end of the program did not persist at the 12-month follow-up, suggesting a need for ongoing support in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Australia's Get Healthy Information and Coaching Service: maintenance of self-reported anthropometric and behavioural changes after program completion. O'Hara, BJ., Phongsavan, P., Eakin, EG., et al.[2021]

The comprehensive lifestyle health coaching (LHC) program has been successfully implemented in various settings, including large employers and healthcare facilities, using technology to deliver services primarily via telephone and the Internet.

Outcomes from published studies and clinical trials demonstrate that the LHC program effectively modifies multiple health risk factors in both healthy individuals and those with chronic diseases, showcasing its clinical effectiveness and integration with traditional medical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of Lifestyle Health Coaching: Case Study of an Evidence-Based Program. Gordon, NF., Salmon, RD., Wright, BS., et al.[2020]

In a study involving 763 overweight participants using a mobile phone-based health coaching service for 4 months, participants lost an average of 3.23% of their total body weight, with 28.6% achieving a clinically significant weight loss of 5% or more.

Among participants with high blood pressure, nearly half (49.1%) improved their blood pressure by an entire hypertensive stage after 4 months of coaching, indicating that digital health coaching can effectively support both weight loss and blood pressure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Phone-Based Health Coaching Intervention for Weight Loss and Blood Pressure Reduction in a National Payer Population: A Retrospective Study. Mao, AY., Chen, C., Magana, C., et al.[2019]

The Healthy Weight Coaching (HWC) program is a comprehensive 12-month internet-based intervention for obesity management that combines Acceptance and Commitment Therapy with personalized coaching, targeting diet, physical activity, psychological factors, and sleep.

With 1189 participants enrolled, the program emphasizes ongoing support through weekly weight logs and 26 scheduled online discussions with coaches, aiming to provide effective long-term weight management solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a web-based real-life weight management program: Study design, methods, and participants' baseline characteristics. Suojanen, LU., Ahola, AJ., Kupila, S., et al.[2022]

Participants in the SBWL+TECH group, who used a wearable physical activity monitor, increased their moderate-to-vigorous physical activity by 132.9 minutes per week, which was three times greater than the SBWL group, although this difference was not statistically significant.

Both groups experienced modest weight loss, with the SBWL+TECH group losing 10.0% of their body weight compared to 7.8% in the SBWL group, indicating that technology-assisted monitoring may help enhance physical activity levels in severely obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity enhancement to a behavioral weight loss program for severely obese individuals: A preliminary investigation. Unick, JL., O'Leary, KC., Bond, DS., et al.[2022]

Fitbit activity trackers show acceptable accuracy for step counting about half the time, often underestimating steps in controlled settings and overestimating in free-living environments, particularly when used by adults without mobility limitations.

The devices are generally unreliable for measuring energy expenditure and may inaccurately estimate time spent in higher-intensity activities and distance during faster walking, suggesting caution in their use for health research and decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of Fitbit Devices: Systematic Review and Narrative Syntheses of Quantitative Data. Feehan, LM., Geldman, J., Sayre, EC., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Telemedicine-Based Health Coaching Is Effective for Inducing Weight Loss and Improving Metabolic Markers. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluating an insurer-based health coaching program: Impact of program engagement on healthcare utilization and weight loss. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Dialing in: effect of telephonic wellness coaching on weight loss. [2015]

4. India pubmed.ncbi.nlm.nih.gov

Factors associated with attrition and success in a worksite wellness telephonic health coaching program. [2014]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of Australia's Get Healthy Information and Coaching Service: maintenance of self-reported anthropometric and behavioural changes after program completion. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of Lifestyle Health Coaching: Case Study of an Evidence-Based Program. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Employee weight management through health coaching. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

A Mobile Phone-Based Health Coaching Intervention for Weight Loss and Blood Pressure Reduction in a National Payer Population: A Retrospective Study. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of a web-based real-life weight management program: Study design, methods, and participants' baseline characteristics. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Physical activity enhancement to a behavioral weight loss program for severely obese individuals: A preliminary investigation. [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

Accuracy of Fitbit Devices: Systematic Review and Narrative Syntheses of Quantitative Data. [2020]