Virtual Health Focused Acceptance-Based Program for Parents and Youth (vHAPPY)

Targeting Self-Regulation in Family-Based Behavioral Treatment for Obesity and Cardiovascular Disease Prevention

The main purpose of vHAPPY is to pilot test a new type of virtual family-based healthy lifestyle program for children aged 8-14 with obesity and their caregivers. vHAPPY aims to (1) Transition a previously developed acceptance-based behavioral treatment to web-based platform, utilizing qualitative and quantitative program evaluation data from past participants. (2) Determine the feasibility, acceptability, and preliminary outcomes of the adapted web-based treatment. (3) Evaluate whether the adapted web-based treatment (self-guided treatment + brief coaching) is similar to the traditional treatment (interventionist-guided treatment) in terms of feasibility, acceptability, and preliminary outcomes utilizing a non-randomized sequential arm design.

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity; Executive Function
• Intervention / Treatment: Behavioral: Web Based Treatment

Detailed Description

Caregiver and child pairs will complete a 14 week virtual, self-guided healthy lifestyle program including education on health and wellness topics such as food groups, physical activity and stress management. Special skill builders for managing the thoughts, feelings and emotions associated with changing health behaviors will also be included. Pairs will have biweekly 15 minute coaching sessions to check in on progress in the past week, set goals and problem solve. Optional group sessions will be offered for peer support. In order to assess progress, pairs will also complete assessment visits before and after the program. These visits include one virtual assessment via Zoom and one in-person assessment at the University of Alabama at Birmingham. Caregivers and children will complete questionnaires and measures such has height, weight, blood pressure and a finger prick.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Children who:

1. have a BMI ≥ 85th percentile;
2. are 8 and 14 years old at the beginning of treatment;
3. can read, write, and speak English, along with their caregiver;
4. plan to stay living in the local area during the study period;
5. have a consenting caregiver who can commit to all study procedures.

Exclusion Criteria:

Children who:

1. have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight, physical activity level or executive function;
2. are currently participating in a formal weight management program beyond usual medical care or have a caregiver participating in a formal weight management program.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Web-Based Treatment; A web-based treatment for pediatric overweight or obesity will be piloted with 10 caregiver and child pairs. Assessments will take place pre (0 months), post intervention (3.5 months) and at six months post-intervention (9.5 months) to evaluate patient outcomes, acceptability and feasibility.

Behavioral: Web Based Treatment; The literature regarding the efficacy of web-based platforms for behavioral weight management interventions in pediatric populations continues to grow. Considering the continued increase in technology and internet use among youth, web-based interventions have the potential to serve as a more cost-effective and personalized approach to pediatric behavioral weight management. Extant research supports this consideration. More research that compares web-based vs. traditional delivery of acceptance-based pediatric behavioral weight management interventions is necessary to understand the utility of this platform as well as which aspects are most effective.; Other Names: Acceptance-Based Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability - Interviews	Semi-structured group interviews will assess caregiver and child experiences with the program.	3.5 months
Acceptability - Surveys	Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.	3.5 months
Feasibility - Interviews	Semi-structured group interviews will assess caregiver and child experiences with the program.	3.5 months
Feasibility - Surveys	Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.	3.5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Body Mass Index Z-Score	Measure child's height and weight. Enter into the Children's Hospital Of Philadelphia Body Mass Index calculator.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Parent Body Mass Index	Measure parent's height and weight. Enter into the Centers for Disease Control adult Body Mass Index calculator.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Parent Subjective Executive Function	Behavior Rating Inventory of Executive Function (BRIEF) - Adult. Subjective EF will be measured using the Behavioral Rating Inventory of Executive Function. The Global Severity Index will be used which is interpreted using T-scores. Higher t-scores indicate better function.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Child Subjective Executive Function	Behavior Rating Inventory of Executive Function (BRIEF) screener and BRIEF 2 (parent-report). Subjective EF will be measured using the Behavioral Rating Inventory of Executive Function. The Global Severity Index will be used which is interpreted using T-scores. Higher t-scores indicate better function.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Parent Behavioral Functioning - Anxiety	Generalized Anxiety Disorder 7. Self-report questionnaire that will be used to measure parent anxiety symptoms over the past 2 weeks. Responses are coded 0-3. 0 = Not at all and 3 = Nearly every day. Total scores range from 0-21 and are ranked from minimal anxiety to severe anxiety.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Parent Behavioral Functioning - Depression	Patient Health Questionnaire 8. Self-report questionnaire that will be used to measure parent depressive symptoms over the past 2 weeks. Eight items, each of which is scored 0-3, providing a 0-24 severity score.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Child Behavioral Functioning - Overall	Pediatric Symptom Checklist -17. A parent-proxy report screener of child risk for internalizing (depression), externalizing (oppositional defiant disorder), and attention problems (ADHD). Each item is rated as never, sometimes or often present and scored 0,1 and 2 respectively. Total score is calculated by adding together the score for each item. Three subscale scores (attention, externalizing and internalizing) are calculated by adding the score for appropriately categorized items.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Physical Activity Behavior	Physical Activity Questionnaire - Child. A self-administered, 7 day recall instrument developed to assess general levels of physical activity in children approximately 8-14 years of age. Provides a summary physical activity score derived from nine items, each scored on a 5 point scale.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Child Eating Behavior	Children's Eating Behavior Questionnaire. A 35-item parent proxy-report measure of eating behavior producing 8 subscales: responsiveness to food, enjoyment of food, satiety responsiveness, slowness in eating, fussiness, emotional overeating, emotional undereating, desire for drinks. Items are scored on a 5-point Likert scale and the mean score of each subscale is used. Higher scores indicate more eating behaviors in a certain domain.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Impact of the Food Environment	Power of Food Scale. A 15-item self-report assessment of the psychological impact of living in food-abundant environments. Items are rated on a 5-point Likert scale and summed to create a total score. Higher scores reflect greater responsiveness to the food environment.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Child Psychological Flexibility - Acceptance	Acceptance Fusion Questionnaire for Youth. A 17-item self-report measure for to assess psychological inflexibility in children. Items are scored on a 5-point Likert scale and summed for a total score ranging between 0-68. Higher scores are indicative of greater psychological inflexibility.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Child Psychological Flexibility - Mindfulness	Child and Adolescent Mindfulness Measure. A 10-item measure of children's awareness and acceptance of their own private events or internal experiences. Items are reverse scored on a 5-point Likert scale. Higher scores correspond to higher levels of mindfulness.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Parent Psychological Flexibility	Parental Acceptance and Action Questionnaire. A 15-item measure that evaluates parents' experiential acceptance and action tendencies in the context of their relationship with their children. The Total score is used which is a sum of all items which are rated on a 7-point Likert scale. Higher scores represent a greater degree of parental experiential avoidance.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Demographics	Child and caregiver characteristics such as age, sex, race/ethnicity, educational level, family income, and marital status will be assessed via caregiver report.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Participant Satisfaction - Interviews	Semi-structured group interviews will assess caregiver and child experiences with the program.	3.5 months
Participant Satisfaction - Surveys	Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.	3.5 months
Adherence	Number of Sessions Attended	3.5 months
Child Health Related Quality of Life - Self Report	Sizing Me Up©. A validated obesity-specific self-report measure, respectively, of health-related quality of life for children 5-13 years old that measure functioning in a variety of areas (e.g., emotional, physical, teasing/marginalization). The Total Score will be used as the outcome, which is a scaled score ranging from 0-100 with higher scores representing better quality of life.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Child Health Related Quality of Life - Parent Report	Sizing Them Up©. A validated obesity-specific parent-report measure, respectively, of health-related quality of life for children 5-13 years old that measure functioning in a variety of areas (e.g., emotional, physical, teasing/marginalization). The Total Score will be used as the outcome, which is a scaled score ranging from 0-100 with higher scores representing better quality of life.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Childrens of Alabama Kaul Pediatric Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Behavioral Intervention; Executive Function; Pediatric Obesity; Acceptance Based
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 300005967

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the small sample size and risk of confidentiality loss, there is no plan to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No