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

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.12345

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.14678

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
See 2 more

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.
See 4 more

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?
1Treatment groups
Experimental Treatment
Group I: GLP-1/Coaching ArmExperimental Treatment1 Intervention

Find a Clinic Near You

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.
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.
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.
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]

Citations

Fitbit-Based Interventions for Healthy Lifestyle OutcomesFor 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) ...
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.
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 ...
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 ...
Social Mobile Approaches to Reducing Weight (SMART) 2.0Adults in the intervention showed a weight loss equal to 3.6%, contrasted against those in the control group who lost 0.6% [29].
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.
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 ...
Proof It Works – Fitbit EnterpriseResearchers at the University of California San Francisco conducted a non-randomized trial of overweight or obese adults at risk for type 2 diabetes.
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