Clinical trial NCT06728800: Leveraging Interactive Digital Technology to Increase Access to Family-Based Behavioral Treatment for Childhood Obesity
Official title: Leveraging Interactive Digital Technology to Increase Access to Family-Based Behavioral Treatment for Childhood Obesity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: 3-C Institute for Social Development
Sponsor class: INDUSTRY
Collaborators: name: Washington University School of Medicine
name: University at Buffalo
First posted: 2024-12-11
Enrollment: 140
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Relative Weight
timeFrame: Baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial
measure: Youth Pediatric Symptom Checklist-17
timeFrame: Baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial
measure: Youth Center for Epidemiological Studies Depression Scale for Children
timeFrame: Baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial
measure: Caregiver Adult Patient Health Questionnaire
timeFrame: Baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial
measure: Family Nutrition and Physical Activity Screening Tool
timeFrame: Baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial
measure: Automated Self-Administered 24-hour Dietary Assessment Tool
timeFrame: Daily during 6-month trial period
measure: Physical activity
timeFrame: 7 days during 6-month trial period
measure: Sizing Them Up
timeFrame: Baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial
measure: Pediatric Quality of Life Inventory
timeFrame: Baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial
measure: Caregiver Short Form(SF)-12 Health Survey
timeFrame: Baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial
measure: Intervention Feedback
timeFrame: At study completion, average of 6 months
measure: After-Scenario Questionnaire (ASQ)
timeFrame: At study completion, average of 6 months
measure: Post-Study System Usability Questionnaire (PSSUQ)
timeFrame: At study completion, average of 6 months
measure: Technology Acceptance Model (TAM)
timeFrame: At study completion, average of 6 months
measure: Product Evaluation
timeFrame: At study completion, average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: 3C Institute
state: North Carolina
Study officials:
affiliation: 3C Institute
name: Melissa DeRosier, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Denise Wilfley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University at Buffalo
name: Leonard Epstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: