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

Browse trials for

• Pediatric Obesity 1,115

Study arms

• Experimental
  FBT 2.0

  Dyads assigned to receive FBT 2.0 will receive all eight modules over the 4-month treatment period, completing approximately one module every two weeks. Dyads will have free access to all completed modules for the duration of the treatment period 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 trial.

  Behavioral: FBT 2.0

• Other
  Delayed-Start Control

  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.

  Behavioral: Delayed-Start Control (AAP educational materials)

Interventions

• BehavioralFBT 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.

• BehavioralDelayed-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.

Primary outcomes

1. 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.

   Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)

2. 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.

   Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)

3. 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.

   Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)

4. 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.

   Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)

5. 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.

   Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)

6. Caregiver Generalized Anxiety Disorder-7 (GAD-7)

   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.

   Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)

7. Youth Screen for Child Anxiety Related Disorders (SCARED)

   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.

   Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)

8. Caregiver Brief Eating Disorder Examination Questionnaire (EDE-Q Brief)

   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.

   Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)

9. Youth Brief Eating Disorder Examination Questionnaire (Youth EDE-Q Brief)

   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.

   Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)

10. Experiences of Weight Stigma

    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.

    Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)

11. Youth Experiences with Teasing and Bullying

    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.

    Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)

12. Food Insecurity (Hunger Vital Sign)

    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.

    Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)

13. Delay Discounting

    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.

    Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)

14. Relative Reinforcing Efficacy of Food

    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.

    Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)

15. 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.

    Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)

16. 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.

    Time frame: 7 days at each assessment timepoint

17. Caregiver PROMIS Global Health

    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.

    Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)

18. Youth PROMIS Pediatric Global Health

    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.

    Time frame: Baseline, post-control (1 to 3 months depending on Cohort), post-treatment (4 months), and 2-month follow-up (6 months)

19. 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.

    Time frame: At completion of the 4-month intervention

20. 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.

    Time frame: At completion of the 4-month intervention

Individual participant data

Plan to share: Yes — Data generated by this project will be made available upon request after the publication of the main findings from each aim. Investigators will require parties requesting data access to submit a detailed description of their plans for the data with their personal identification, institutional affiliation, a CV, estimated duration of the proposed research, source of financial support, and a conflict-of-interest statement. The MPIs will decide whether sharing of the data is appropriate or if other information and/or additional safeguards are needed. Once the request is approved, data transfer and use agreements will be developed if necessary, and the requesting investigator must obtain approval from their institution's IRB or request to rely on the IRB of record. Appropriate de- identification techniques required by both HIPAA and the Common Rule will allow for sharing of data that does not compromise participant confidentiality.