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

Relative Weight

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: 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.

Delay Discounting

时间窗: 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.

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

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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.

Relative Reinforcing Efficacy of Food

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

Sizing Them Up

时间窗: 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.

Pediatric Quality of Life Inventory

时间窗: 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.

Relative Weight

时间窗: 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.

Youth Pediatric Symptom Checklist-17

时间窗: 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.

Youth Center for Epidemiological Studies Depression Scale for Children

时间窗: 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.

Caregiver Adult Patient Health Questionnaire

时间窗: 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.

Family Nutrition and Physical Activity Screening Tool

时间窗: 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.

Automated Self-Administered 24-hour Dietary Assessment Tool

时间窗: 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.

Physical activity

时间窗: 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.

Caregiver Short Form(SF)-12 Health Survey

时间窗: 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.

Intervention Feedback

时间窗: 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.

After-Scenario Questionnaire (ASQ)

时间窗: 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.

Post-Study System Usability Questionnaire (PSSUQ)

时间窗: 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.

Technology Acceptance Model (TAM)

时间窗: 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.

Product Evaluation

时间窗: 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.