Digital Family-Based Treatment for Childhood Obesity

(FBT 2 Trial)

MD
Overseen ByMelissa DeRosier, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: 3-C Institute for Social Development
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 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.12345

Why 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?

MD

Melissa DeRosier, PhD

Principal Investigator

3C Institute

LE

Leonard Epstein, PhD

Principal Investigator

University at Buffalo

DW

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

* must be youth between the ages of 6 and 18
* must have a body mass index (BMI) percentile greater than or equal to the 95th BMI percentile for age and sex

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of participants' health and behaviors before starting the intervention

1 week
1 visit (in-person)

Treatment

Participants receive the FBT 2.0 intervention, completing one module every two weeks over a six-month period

24 weeks
Weekly sessions (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 and 6 months

6 months
3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • FBT 2.0
Trial Overview FBT 2.0, an 'all-in-one' digital product designed to help manage childhood obesity through interactive online tools for kids and parents, is being tested against standard information-and-referral services.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Information-and-referral ControlExperimental Treatment1 Intervention
Group II: FBT 2.0Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

3-C Institute for Social Development

Lead Sponsor

Trials
15
Recruited
2,300+

Washington University School of Medicine

Collaborator

Trials
2,027
Recruited
2,353,000+

University at Buffalo

Collaborator

Trials
139
Recruited
105,000+

Published Research Related to This Trial

Family-based behavioral treatment (FBBT) for childhood obesity was well-accepted in a clinical setting in the UK, with 82% of participating families completing the 12-session program.
Children in the program experienced an average BMI reduction of 8.4%, which was maintained at a 3-month follow-up, alongside improvements in self-esteem and mood, indicating the treatment's efficacy without negative psychological effects.
Family-based behavioural treatment of obesity: acceptability and effectiveness in the UK.Edwards, C., Nicholls, D., Croker, H., et al.[2016]
In a 6-month family-based treatment program for childhood obesity, both parents and children experienced significant weight loss, indicating that family involvement is crucial for effective weight management.
The study found that a parent's initial weight loss positively influenced their child's subsequent weight loss, and vice versa, highlighting the mutual influence between parent and child in achieving weight loss goals.
Evaluation of dyadic changes of parent-child weight loss patterns during a family-based behavioral treatment for obesity.Kang Sim, DE., Strong, DR., Manzano, MA., et al.[2022]
The pilot study involving 77 adolescents showed that family-based treatment for pediatric obesity (FBT-PO) effectively stabilized weight in participants, while those receiving nutrition education counseling (NEC) experienced weight gain.
Although FBT-PO did not significantly reduce body mass index z-scores, it demonstrated potential in preventing further weight gain, highlighting the importance of parental involvement in treating pediatric obesity.
Adapting family-based treatment for paediatric obesity: A randomized controlled pilot trial.Loeb, KL., Le Grange, D., Celio Doyle, A., et al.[2020]

Citations

Family-Based Interventions for Pediatric ObesityStudies have indicated that family-based treatment (FBT) is a cost-effective and successful option for achieving significant weight changes in both children ...
Study Details | NCT06728800 | Leveraging Interactive ...FBT 2.0 is a translation of Family-Based Behavioral Treatment (FBT) into an e-health intervention product for families with a child/adolescent with obesity. FBT ...
Parenting Training Plus Behavioral Treatment for Children ...The findings suggest that FBT reduces weight status in children with overweight or obesity but that additional intensive PT does not further improve outcomes.
Implementing family-based behavioral treatment in the ...It is hypothesized that the FBT intervention will be associated with better changes in relative weight for children, parents, and siblings than usual care. The ...
Evidence Base Update on Behavioral Treatments for ...This review provides an update to a previous Evidence Base Update addressing behavioral treatments for overweight and obesity in children and adolescents.
Digital Family-Based Treatment for Childhood ObesityThe FBT 2 medical study, being run by 3-C Institute for Social Development, needs participants to evaluate whether FBT 2.0 will have tolerable side effects ...
A randomized controlled trial examining general parenting ...This clinical trial tests the effect of parenting training on childhood obesity. Results will inform the development of more effective treatments.
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