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

140 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the treatment FBT 2.0 for childhood obesity?

Family-based treatment (FBT) for childhood obesity has been shown to help families make healthier choices at home and in their neighborhoods, and it is effective in promoting weight loss in children, especially when parents also lose weight. ^{1 2 3 4 5}

Is the Digital Family-Based Treatment for Childhood Obesity safe for children?

The research articles do not provide specific safety data for the Digital Family-Based Treatment for Childhood Obesity, but they focus on its effectiveness and acceptability in treating childhood obesity. ^{1 2 3 6 7}

How is the FBT 2.0 treatment for childhood obesity different from other treatments?

FBT 2.0 is unique because it combines family-based behavioral strategies with digital tools to help families make healthier choices at home and in their neighborhoods, focusing on both nutrition and physical activity. This approach emphasizes the role of the family environment and uses mobile health apps to support behavior change, which is different from traditional treatments that may not involve digital components or focus on the family unit. ^{1 2 4 8 9}

What is the purpose of this trial?

The primary goal of this SBIR Direct to Phase II is to expand upon the existing training platform to create an "all-in-one" digital product, FBT 2.0, that offers an integrated suite of intervention components, including (a) dynamic, personalized, self-paced program for children and parent/caregivers; (b) e-training and ongoing support for interventionists; and (c) family engagement and monitoring tools for interventionists. Investigators will create a comprehensive, e-learning digital intervention with engaging, interactive, and personalized online tools for youth and their parents/caregivers that are integrated into the broader interventionist platform.

Research Team

Denise E. Wilfley, PhD

Principal Investigator

Washington University School of Medicine

Leonard Epstein, PhD

Principal Investigator

University at Buffalo

Melissa DeRosier, PhD

Principal Investigator

3C Institute

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Home and neighbourhood built environment features in family-based treatment for childhood obesity. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Family-based behavioural treatment of obesity: acceptability and effectiveness in the UK. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Racial and socioeconomic disparities in the efficacy of a family-based treatment programme for paediatric obesity. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of dyadic changes of parent-child weight loss patterns during a family-based behavioral treatment for obesity. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Family Functioning and Childhood Obesity Treatment: A Family Systems Theory-Informed Approach. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Children with Severe Obesity in Family-Based Obesity Treatment Compared with Other Participants: Conclusions Depend on Metrics. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Assessment of Parents' Preferences for Incentives to Promote Engagement in Family-Based Childhood Obesity Treatment. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Mobile Health Apps in Pediatric Obesity Treatment: Process Outcomes From a Feasibility Study of a Multicomponent Intervention. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Adapting family-based treatment for paediatric obesity: A randomized controlled pilot trial. [2020]