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

Study acronym: FBT 2
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later Apr 30, 2026 → Jul 31, 2027
Primary endpoints added 15 → 20 primary endpoints
Enrollment reduced 53% 140 → 66 participants
See other at-risk trials from 3-C Institute for Social Development

Record History

  1. Primary endpoint(s) modified Enrollment reduced: 140 → 66 participants · Start date moved earlier from Jan 4, 2027 to Oct 1, 2026 · Interventions modified · 2 more Show 5 more changesShow less
    • Enrollment reduced: 140 → 66 participants
    • Start date moved earlier from Jan 4, 2027 to Oct 1, 2026
    • Interventions modified
    • Eligibility criteria expanded, about 64 words
    • Study description expanded, about 22 words
  2. Primary completion pushed from Apr 30, 2026 to Jul 31, 2027 Start date: Oct 1, 2025 to Jan 4, 2027 · Completion pushed from Apr 30, 2026 to Sep 30, 2027v3 Show 2 more changesShow less
    • Start date: Oct 1, 2025 to Jan 4, 2027
    • Completion pushed from Apr 30, 2026 to Sep 30, 2027
  3. Start date: Aug 1, 2025 to Oct 1, 2025 Primary and study completion dates: Jun 30, 2026 to Apr 30, 2026v2 Show 1 more changeShow less
    • Primary and study completion dates: Jun 30, 2026 to Apr 30, 2026
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06728800
Lead Sponsor 3-C Institute for Social Development
Collaborators: Washington University School of Medicine, University at Buffalo
Conditions Childhood Obesity
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov