Leveraging Interactive Digital Technology to Increase Access to Family-Based Behavioral Treatment for Childhood Obesity (FBT 2)

3-C Institute

Status: Not yet enrolling

Conditions: Childhood Obesity

Treatments: Behavioral: FBT 2.0; Behavioral: Information-and-referral

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06728800

FBT 2.0 DPII

Details and patient eligibility

About

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.

Full description

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. For the Pilot test , investigators will randomly assign half of the enrolled dyads (by age group i.e., 6 to 12, > 12) to FBT 2.0 and half to the information-and-referral control condition. 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.

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.

The same set of outcome measures will be collected for children and caregivers in both conditions at each of three timepoints: (1) prior to starting the trial (baseline); (2) at 3 months into the trial; and (3) at 6 months (after completing their last module). For all participants randomized to FBT 2.0, software usage data will be collected throughout the six-month trial and product evaluations will be collected at post- intervention.

Enrollment: 140 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: Accepts Healthy Volunteers

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
• must have one caregiver participate, who is at least 18 years of age and lives with the child at least 50% of the time.

Exclusion criteria

• co-morbid disorders that contraindicate weight loss (e.g., eating disorder).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

FBT 2.0

Experimental group

Description:

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.

Treatment:

Behavioral: FBT 2.0

Information-and-referral Control

Other group

Description:

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.

Treatment:

Behavioral: Information-and-referral