Digital Family-Based Treatment for Childhood Obesity
(FBT 2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new digital program called FBT 2.0 (Family-Based Treatment), designed to help children with obesity and their caregivers manage weight more effectively. The goal is to determine if this online program can better support families with engaging and personalized tools compared to standard educational materials alone. Families will participate in the program for six months, completing modules and receiving guidance from trained interventionists. Children diagnosed with obesity (BMI at or above the 95th percentile) and who have a caregiver willing to participate are good candidates for this study. As an unphased trial, this study offers families the opportunity to access innovative support tools that could enhance their weight management journey.
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications.
What prior data suggests that this digital intervention is safe for children and families?
Research has shown that family-based treatment (FBT), the foundation of FBT 2.0, is generally safe and effective for children with obesity. Although specific data on side effects for FBT 2.0 is not yet available, traditional FBT has enabled families to manage weight without major issues.
FBT 2.0 adapts this proven method into a digital format. As an online program focused on changing behaviors and lifestyles, it is unlikely to cause serious side effects. It primarily includes educational lessons and support sessions, which families manage well. Studies have shown that similar programs are safe for both children and their caregivers.12345Why are researchers excited about this trial?
Researchers are excited about the Digital Family-Based Treatment (FBT 2.0) for childhood obesity because it leverages technology to engage families in a comprehensive approach. Unlike traditional options that often involve in-person sessions or basic educational materials, FBT 2.0 offers a fully digital platform that allows families to access interactive modules from home. Each family receives personalized support through weekly interventionist-led sessions and additional coaching via text or video, making it more flexible and accessible. This digital format not only empowers families to work on healthy habits at their own pace but also ensures consistent guidance and support throughout the six-month program.
What evidence suggests that FBT 2.0 is effective for childhood obesity?
Studies have shown that Family-Based Treatment (FBT) helps children and teens with obesity achieve significant weight changes. Research indicates that FBT involves the whole family in the treatment process to assist children with overweight or obesity. In this trial, participants will receive either FBT 2.0, a digital version of this treatment, or an information-and-referral control intervention. FBT 2.0 is designed as an easy-to-use, interactive program for families to manage weight effectively. Previous findings suggest that this approach is not only cost-effective but also supports better weight management compared to usual care. The digital format of FBT 2.0 provides personalized, engaging, and supportive help that families can conveniently access from home.12467
Who Is on the Research Team?
Melissa DeRosier, PhD
Principal Investigator
3C Institute
Leonard Epstein, PhD
Principal Investigator
University at Buffalo
Denise E. Wilfley, PhD
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for children and their parents/caregivers dealing with childhood obesity. Participants should be willing to engage with a digital platform that includes self-paced programs, support tools, and monitoring by interventionists.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Initial assessment of participants' health and behaviors before starting the intervention
Treatment
Participants receive the FBT 2.0 intervention, completing one module every two weeks over a six-month period
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 3 and 6 months
What Are the Treatments Tested in This Trial?
Interventions
- FBT 2.0
Find a Clinic Near You
Who Is Running the Clinical Trial?
3-C Institute for Social Development
Lead Sponsor
Washington University School of Medicine
Collaborator
University at Buffalo
Collaborator