Digital Family-Based Treatment for Childhood Obesity

(FBT 2 Trial)

Overseen By Melissa DeRosier, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: 3-C Institute for Social Development

Disqualifiers: Eating disorder, others

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

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

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

* 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?

Group I: Information-and-referral Control Experimental Treatment 1 Intervention

Caregiver-youth dyads randomized to the information-and-referral control intervention will be given written educational materials. Prior to starting the intervention trial, dyads will meet for 20 minutes with a trained researcher who will provide them with educational materials used in investigators' prior studies which teaches about the impact of eating and activity behaviors on weight. Caregivers will be asked to monitor their health by using daily paper-and-pencil diaries to record eating and activity behaviors. Youth without a medical provider will be given referrals to a primary care provider in their community.

Group II: FBT 2.0 Experimental Treatment 1 Intervention

Dyads assigned to receive FBT 2.0 will receive all eight modules over the six-month trial, completing one module every two weeks. Dyads will have free access to all completed modules for the duration of the six-month trial. Each module is expected to take approximately two to three sessions to complete, each session lasting approximately 45 minutes. At least one interventionist-led session (20-30 minutes) will occur per week, with additional sessions or coach support as needed via text exchange and/or videoconferencing supported on the website. Families will be able to engage with the software for as long as desired during the six-month trial.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting family-based treatment for paediatric obesity: A randomized controlled pilot trial. Loeb, KL., Le Grange, D., Celio Doyle, A., et al.[2020]

Family-based care for childhood obesity should not only focus on the parent-youth relationship but also consider the entire family dynamics, as these can significantly influence weight-related behaviors.

The paper emphasizes the need for family systems theory (FST) in obesity treatment, providing a clinical algorithm for healthcare providers to assess and intervene in family dynamics, which could lead to more effective obesity management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Functioning and Childhood Obesity Treatment: A Family Systems Theory-Informed Approach. Pratt, KJ., Skelton, JA.[2021]

Family-based behavioral weight loss treatment (FBT) was effective in promoting weight loss in children across different socioeconomic and racial groups, with a study involving 172 youth over 12 months.

However, Black children and those from low-income families experienced less weight loss by the 4-month mark, indicating a need for further research to optimize FBT for these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Racial and socioeconomic disparities in the efficacy of a family-based treatment programme for paediatric obesity. Davison, GM., Fowler, LA., Ramel, M., et al.[2021]

The study involved 20 children and adolescents with obesity, who were randomized to either an mHealth intervention group using the Mandolean app or a control group receiving usual care, but faced a high attrition rate of 63% in the intervention group compared to 25% in the control group.

Low engagement with the Mandolean app and perceived task burden were significant barriers to adherence, suggesting that while self-monitoring tools like the myBigO app and smartwatches were acceptable, further improvements in the usability and acceptability of the Mandolean intervention are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Apps in Pediatric Obesity Treatment: Process Outcomes From a Feasibility Study of a Multicomponent Intervention. Browne, S., Kechadi, MT., O'Donnell, S., et al.[2021]

After 12 months of family-based obesity treatment, 40% of children with severe obesity no longer met the criteria for severe obesity, indicating the efficacy of the intervention.

Children with severe obesity showed improvements in psychosocial distress similar to those with mild obesity/overweight, suggesting that the treatment not only helps with weight loss but also supports mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Children with Severe Obesity in Family-Based Obesity Treatment Compared with Other Participants: Conclusions Depend on Metrics. Hayes, JF., Fowler, LA., Balantekin, KN., et al.[2022]

The study involved 181 parent-child dyads who participated in a 16-session family-based behavioral weight loss treatment (FBT) program, which successfully led families to make healthier modifications in their home food environment.

Reducing the availability of high-energy-dense (RED) foods and electronics in the home during FBT was positively associated with improvements in child weight and related outcomes, highlighting the importance of the home environment in achieving weight loss success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home and neighbourhood built environment features in family-based treatment for childhood obesity. Hayes, JF., Balantekin, KN., Conlon, RPK., et al.[2020]

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