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

Condition(s) studied

Investigational drug(s) / intervention(s)

FBT 2.0: 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.

Delayed-Start Control (AAP educational materials): All 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Relative Weight — Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
  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 — Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
  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 — Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
  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 — Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
  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.
• Family Nutrition and Physical Activity Screening Tool — Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
  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.
• Caregiver Generalized Anxiety Disorder-7 (GAD-7) — Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
  Caregiver: The GAD-7 is a 7-item measure of anxiety symptoms. Items are scored 0-3; total scores range 0-21, with higher scores indicating greater anxiety severity.
• Youth Screen for Child Anxiety Related Disorders (SCARED) — Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
  Youth: The 5-item SCARED is a brief screening measure for child anxiety disorders. Items are scored 0-2; total scores range 0-10, with higher scores indicating greater anxiety and scores of 3 or higher indicating possible anxiety disorder.
• Caregiver Brief Eating Disorder Examination Questionnaire (EDE-Q Brief) — Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
  Caregiver: The EDE-Q Brief is a brief self-report version of the Eating Disorder Examination Questionnaire assessing eating disorder psychopathology. Higher scores indicate greater eating disorder pathology.
• Youth Brief Eating Disorder Examination Questionnaire (Youth EDE-Q Brief) — Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
  Youth: The Youth EDE-Q Brief (Body U) is a brief youth-report version of the Youth Eating Disorder Examination Questionnaire assessing eating disorder psychopathology. Higher scores indicate greater eating disorder pathology.
• Experiences of Weight Stigma — Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
  Experiences of weight-based stigma will be assessed by self-report for caregivers and youth, with higher scores indicating more frequent experiences of weight stigma.
• Youth Experiences with Teasing and Bullying — Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
  Youth: The Experiences with Teasing and Bullying measure is a 12-item youth-report tool evaluating experiences of teasing and bullying, administered verbally for children under age 8. Higher scores indicate more frequent experiences.
• Food Insecurity (Hunger Vital Sign) — Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
  Caregiver: The Hunger Vital Sign is a validated 2-item food insecurity screener. An affirmative response to either item indicates risk of household food insecurity.
• Delay Discounting — Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
  Youth and Caregiver: The Delay Discounting Task measures the tendency to discount the value of delayed rewards. Steeper discounting rates indicate greater preference for immediate rewards.
• Relative Reinforcing Efficacy of Food — Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
  Youth and Caregiver: The relative reinforcing value of food is measured by questionnaire, with higher scores indicating greater reinforcing value of food relative to alternative activities.
• Automated Self-Administered 24-hour Dietary Assessment Tool — Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
  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.
• Physical activity — 7 days at each assessment timepoint
  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.
• Caregiver PROMIS Global Health — Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
  Caregiver: The PROMIS Global Health scale (v1.2) is a 10-item measure of overall physical and mental health-related quality of life. Items are scored on 5-point scales; raw scores are converted to T-scores, with higher scores indicating better health.
• Youth PROMIS Pediatric Global Health — Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)
  Youth: The PROMIS Pediatric Global Health 7+2 is a 9-item child-report measure of perceived physical, mental, and social health. Raw scores are converted to T-scores, with higher scores indicating better global health.
• Intervention Feedback — At completion of the 4-month intervention
  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.
• Product Evaluation — At completion of the 4-month intervention
  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.

Trial sites (1)

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