Digital Family-Based Treatment for Childhood Obesity (FBT 2 Trial)

Durham, NC

N/A

Waitlist Available

Led By Denise Wilfley, PhD

Research Sponsored by 3-C Institute for Social Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to enhance a training platform to develop a digital product called FBT 2.0. This product will include personalized programs for children and their caregivers, training for interventionists, and tools for family engagement. The goal is to create an engaging online intervention program for children and families as part of a broader platform.

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Who is the study for?

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.

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves a digital behavioral treatment rather than medication, traditional side effects are not expected. However, participants may experience stress or frustration if they find the technology challenging.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

After-Scenario Questionnaire (ASQ)

Automated Self-Administered 24-hour Dietary Assessment Tool

Caregiver Adult Patient Health Questionnaire

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Information-and-referral ControlExperimental Treatment1 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 2.0Experimental Treatment1 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.

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