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NOT YET RECRUITING
NCT06728800
NA

Leveraging Interactive Digital Technology to Increase Access to Family-Based Behavioral Treatment for Childhood Obesity

Sponsor: 3-C Institute for Social Development

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

6 Years - Any

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2026-10-01

Completion Date

2027-09-30

Last Updated

2026-09-28

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

FBT 2.0

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 is an evidence-based obesity intervention that takes a family-centered approach to weight management that includes training in behavioral skills for the family, such as self-monitoring, stimulus control, problem solving, pre-planning, and impulse control. Youth with obesity, along with one participating caregiver, will be introduced to the evidence- based Traffic Light Eating Plan and behavioral skill training appropriate for their developmental age, while the caregiver learns positive parenting approaches to help shape and support their child's weight change efforts in addition to their own weight management goals. The final product will consist of eight modules, each aligned with evidence-based FBT skills and competencies.

BEHAVIORAL

Delayed-Start Control (AAP educational materials)

All caregiver-youth dyads receive the FBT 2.0 intervention. At enrollment, dyads are randomized to one of three delayed-start cohorts that begin treatment after a 1-, 2-, or 3-month control period. During the control period, dyads receive a link to American Academy of Pediatrics educational materials on healthy eating, physical activity, screen time, and sleep, and complete weight measurements; no treatment components are delivered. Prior to enrollment, dyads complete a 1-week run-in during which the caregiver and youth each log daily dietary intake using an online dietary tracking survey; dyads in which both members complete diary entries on at least 5 of 7 days are enrolled.

Locations (1)

3C Institute

Durham, North Carolina, United States