Fitbit-Supported Health Coaching for Obesity

(FIT-COACH Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

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)

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how using a Fitbit and working with a health coach can help people with obesity increase their physical activity. The goal is to determine if this support can improve health, even without weight loss. Participants will engage in a 12-week program that includes virtual sessions with a health coach and activity tracking with a Fitbit. It suits those who have been taking a specific weight-loss medication (GLP-1/GIP) for at least three months and are patients at UMass Medical Group Primary Care Clinic. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance obesity management strategies.

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 prior data suggests that this health coaching program with Fitbit is safe for individuals with overweight/obesity?

Research shows that using Fitbit can lead to positive health changes. Participants in these studies have increased their physical activity, taking more steps and engaging in more moderate-to-vigorous exercise. They also lost weight, which benefits those who are overweight or have obesity.

Combining Fitbit with health coaching appears promising as well. Studies have explored how this combination can aid weight and heart health, yielding encouraging results. This approach supports healthier lifestyle habits, crucial for long-term health.

Overall, using a Fitbit with health coaching is well-received. Research has not reported any major safety issues, and participants seem to manage the program well, making it a safe option to consider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fitbit-supported health coaching for obesity is unique because it combines wearable technology with personalized health coaching. Traditional treatments often rely on medication or surgery, but this approach focuses on behavior change and real-time feedback. The use of a Fitbit allows patients to track their activity levels and progress, while the health coach provides tailored guidance and motivation through virtual sessions. Researchers are excited about this treatment because it empowers individuals to take control of their health in a more interactive and engaging way, potentially leading to sustainable lifestyle changes.

What evidence suggests that this Fitbit-supported health coaching program is effective for obesity?

Research has shown that using a Fitbit can help people become more active, with an average increase of about 950 steps per day. This boost in activity can improve overall health. In this trial, participants in the GLP-1/Coaching Arm will receive a Fitbit and health coaching, which has proven effective for managing weight. One study found that participants lost an average of 2.15 kg, indicating that this method can assist with weight loss goals. Even without weight loss, increased activity can benefit metabolism and heart health. This combination of technology and personal coaching appears promising for those facing challenges with being overweight or obese. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7589007/

Fitbit-Based Interventions for Healthy Lifestyle Outcomes

For Fitbit-based interventions, we found a statistically significant increase in daily step count (mean difference [MD] 950.54, 95% CI 475.89-1425.18; P<.001) ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06915090

FIT-COACH: Fitbit Intervention With Coordinated Health ...

In individuals with overweight/obesity, increases in physical activity (PA) can improve metabolic and cardiovascular health, independent of weight loss.

3.

jmir.org

jmir.org/2023/1/e42432/

Effectiveness of Combined Health Coaching and Self ...

Using combined intervention significantly improved weight loss by 2.15 kg (95% CI −3.17 kg to −1.12 kg; P<.001; I2=60.3%), waist circumference ...

4.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0232221

Outcomes in a digital weight management intervention with ...

Six hundred eighty-three participants reported 29,051 weights. At 12 months, mean percent changes in body weight were -7.2% and -7.6% for ...

5.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05938-7

Social Mobile Approaches to Reducing Weight (SMART) 2.0

Adults in the intervention showed a weight loss equal to 3.6%, contrasted against those in the control group who lost 0.6% [29].

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06915090

FIT-COACH: Fitbit Intervention With Coordinated Health ...

In individuals with overweight/obesity, increases in physical activity (PA) can improve metabolic and cardiovascular health, independent of weight loss.

7.

nature.com

nature.com/articles/s41598-024-60811-2

Using explainable machine learning and fitbit data to ...

The wearables' convenience for health monitoring offers potential for early obesity intervention and promoting healthier behaviors, especially ...

8.

fitbit.google

fitbit.google/enterprise/proof-it-works/

Proof It Works – Fitbit Enterprise

Researchers at the University of California San Francisco conducted a non-randomized trial of overweight or obese adults at risk for type 2 diabetes.