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.
must be youth between the ages of 6 and 17
must have a body mass index (BMI) percentile greater than or equal to the 85th 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.
the participating caregiver must have a body mass index (BMI) of 25 or greater
co-morbid disorders that contraindicate weight loss (e.g., eating disorder).
caregiver has a medical or psychiatric condition in which weight loss is contraindicated (e.g., pregnancy)
youth is unable to provide assent
Sequential
FBT 2.0
BehavioralFBT 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.
Delayed-Start Control (AAP educational materials)
BehavioralAll 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.
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.
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.
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.
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.
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3-C Institute for Social Development
Lead sponsor
Washington University School of Medicine
Collaborator
University at Buffalo
Collaborator
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