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

NCT06728800 | Not Yet Recruiting

• 1 other identifier: FBT 2.0 DPII
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (15)

• Relative Weight

  Youth: The participating caregiver is given the CDC guidelines for "Measuring Children's Height and Weight Accurately at Home." The FBT coach will review these guidelines with the caregiver to assure comprehension. Median body mass index (BMI) for that child's age (in months) and sex is based on norms defined by Kuczmarski and colleagues and available from the CDC. Percent overweight was chosen as the primary outcome measure given its sensitivity to change throughout the BMI range. Caregiver: Exploratory analyses will examine caregiver weight change, defined as percent change from weight at baseline, among caregivers who have obesity (BMI ≥ 30) at baseline.

  Baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial

• Youth Pediatric Symptom Checklist-17

  Youth: The Pediatric Symptom Checklist-17 is a widely used, briefer version of the PSC-35, a caregiver-completed measure of children's psychosocial functioning, where caregivers rate each symptom on a scale of 0-2, where 0 means never, 1 means sometimes, and 2 means often.

  Baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial

• Youth Center for Epidemiological Studies Depression Scale for Children

  Youth: Depression is measured in children using a 20-item Center for Epidemiological Studies Depression Scale for Children. Possible scores range from 0-60 with each item response scored as 0 = Not At All, 1 = A Little, 2 = Some, and 3 = A Lot.

  Baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial

• Caregiver Adult Patient Health Questionnaire

  Caregiver: Adults complete the 2- item Patient Health Questionnaire to measure depression. Each symptom is scored on a scale of 0-3, with 0 = Not At All, 1 = Several Days, 2 = More than half the Days, and 3 = Nearly every day.

  Baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial

• Family Nutrition and Physical Activity Screening Tool

  The Family Nutrition \& Physical Activity Screening Tool is a 20-item parent-report scale designed to assess family environments and practices that have been shown to be associated with children's risk of becoming overweight. Each item is scored on a 1-4 point scale with 4 representing the more favorable practice or policy.

  Baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial

• Automated Self-Administered 24-hour Dietary Assessment Tool

  The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool is a free, web-based tool that enables automatically coded, self-administered 24-hour diet recalls that will be completed by the participating adolescent aged 13 or older, or with the caregiver's assistance (for youth \< 13 years of age). The caregiver will also complete a 24-hour dietary recall for their own intake. Outcomes will be average daily kilocalories, fruit and vegetable servings, and percentage intake from fat.

  Daily during 6-month trial period

• Physical activity

  Objective physical activity will be assessed for youth and caregivers using accelerometers worn on the wrist during sleep and daily activities for seven days at each assessment time point. Outcomes will be minutes of moderate or vigorous activity (physical activity) and minutes of sedentary activity.

  7 days during 6-month trial period

• Sizing Them Up

  Youth: Sizing Them Up is a 22-item parent-report weight-specific quality of life measure used to assess the impact of weight on the child's health and on their day-to-day functioning. Each item is scored on a 1-4 scale, with 1 = Never, 2 = Sometimes, 3 = Often, and 4 = always, with lower scores meaning a better outcome.

  Baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial

• Pediatric Quality of Life Inventory

  Youth: The Pediatric Quality of Life Inventory is a modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18. Each item is scored on a scale from 0 - 4, with 0 = never a problem, 1 = almost never a problem, 2 = sometimes a problem, 3 = often a problem, and 4 = a lot of a problem, with lower scores being a more favorable outcome.

  Baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial

• Caregiver Short Form(SF)-12 Health Survey

  The SF-12 Health Survey is a shorter version of the SF-36 designed to assess the caregiver's functional health and well-being, and overall quality of life. Higher scores mean a better health-related quality of life, with lower scores suggesting below-average health.

  Baseline at start of trial, at 3-month timepoint, and at 6-month conclusion of trial

• Intervention Feedback

  Caregivers and youth in both conditions will provide feedback regarding their experiences during the trial period. On a 5-point scale (1=Strongly Disagree to 5=Strongly Agree), respondents will rate the degree to which their experience was: (a) useful for increasing knowledge of weight-related behaviors; (b) useful for learning self-management skills; (c) helped with changing unhealthy behaviors; (d) valuable for families and youth with obesity; (e) engaging for families; (f) innovative compared to alternatives; and (g) better than alternatives. Additionally, child and parent satisfaction with FBT will be assessed at the end of treatment using the 8-item Client Satisfaction Questionnaire. Participants will also be asked to provide written comments, listing specific concerns or problems. Follow-up interviews via telephone by trained research assistants will be conducted to clarify responses and gather additional details, as needed.

  At study completion, average of 6 months

• After-Scenario Questionnaire (ASQ)

  The After-Scenario Questionnaire (ASQ) is a 3-item measure on which adolescents will rate their satisfaction with FBT 2.0.

  At study completion, average of 6 months

• Post-Study System Usability Questionnaire (PSSUQ)

  The Post-Study System Usability Questionnaire (PSSUQ) is a 19-item survey assessing overall user satisfaction with the system and interface.

  At study completion, average of 6 months

• Technology Acceptance Model (TAM)

  Technology Acceptance Model (TAM) is a 16-item measure assessing end-user acceptance of technology in the areas of perceived usefulness, perceived ease of use, and attitudes towards using.

  At study completion, average of 6 months

• Product Evaluation

  In addition, participants will rate (5-point scale from 1=Not at all to 5=Extremely) the quality of FBT 2.0 in the following areas: (a) user friendly; (b) easy to navigate; (c) appealing graphic design; (d) easy to follow directions; (e) jargon free; (f) engaging; (g) high quality content; (h) high value content; (i) relevance to real-life; (j) login functions; (k) search functions; and (l) help functions.

  At study completion, average of 6 months

Study Arms (2)

FBT 2.0

EXPERIMENTAL

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.

Behavioral: FBT 2.0

Information-and-referral Control

OTHER

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.

Behavioral: Information-and-referral

Interventions

FBT 2.0 BEHAVIORAL

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.

FBT 2.0

Information-and-referral BEHAVIORAL

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.

Information-and-referral Control

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• 3-C Institute for Social Development: lead
• Washington University School of Medicine: collaborator
• University at Buffalo: collaborator

Study Sites (1)

3C Institute

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melissa DeRosier, PhD

  3C Institute

  PRINCIPAL INVESTIGATOR

• Denise Wilfley, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Leonard Epstein, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa DeRosier, PhD

CONTACT

984-316-0406; derosier@3cisd.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: October 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)