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

Primary outcomes

1. Relative Weight

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

   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.

2. Youth Pediatric Symptom Checklist-17

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

   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.

3. Youth Center for Epidemiological Studies Depression Scale for Children

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

   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.

4. Caregiver Adult Patient Health Questionnaire

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

   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.

5. Family Nutrition and Physical Activity Screening Tool

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

   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.

6. Automated Self-Administered 24-hour Dietary Assessment Tool

   Time frame: Daily during 6-month trial period

   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.

7. Physical activity

   Time frame: 7 days during 6-month trial period

   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.

8. Sizing Them Up

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

   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.

9. Pediatric Quality of Life Inventory

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

   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.

10. Caregiver Short Form(SF)-12 Health Survey

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

    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.

11. Intervention Feedback

    Time frame: At study completion, average of 6 months

    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.

12. After-Scenario Questionnaire (ASQ)

    Time frame: At study completion, average of 6 months

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

13. Post-Study System Usability Questionnaire (PSSUQ)

    Time frame: At study completion, average of 6 months

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

14. Technology Acceptance Model (TAM)

    Time frame: At study completion, average of 6 months

    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.

15. Product Evaluation

    Time frame: At study completion, average of 6 months

    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.