search
Back to results

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

Primary Purpose

Pediatric Obesity, Executive Function

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web Based Treatment
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring Pediatric Obesity, Executive Function, Behavioral Intervention, Acceptance Based

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Web-Based Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Child Body Mass Index Z-Score
Measure child's height and weight. Enter into the Children's Hospital Of Philadelphia Body Mass Index calculator.
Parent Body Mass Index
Measure parent's height and weight. Enter into the Centers for Disease Control adult Body Mass Index calculator.
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.
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.
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.
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.
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.

Full Information

First Posted
November 3, 2020
Last Updated
August 30, 2022
Sponsor
University of Alabama at Birmingham
Collaborators
Childrens of Alabama Kaul Pediatric Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT04634045
Brief Title
Virtual Health Focused Acceptance-Based Program for Parents and Youth
Acronym
vHAPPY
Official Title
Targeting Self-Regulation in Family-Based Behavioral Treatment for Obesity and Cardiovascular Disease Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Childrens of Alabama Kaul Pediatric Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Executive Function
Keywords
Pediatric Obesity, Executive Function, Behavioral Intervention, Acceptance Based

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Web-Based Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Web Based Treatment
Other Intervention Name(s)
Acceptance-Based Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability - Interviews
Description
Semi-structured group interviews will assess caregiver and child experiences with the program.
Time Frame
3.5 months
Title
Acceptability - Surveys
Description
Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.
Time Frame
3.5 months
Title
Feasibility - Interviews
Description
Semi-structured group interviews will assess caregiver and child experiences with the program.
Time Frame
3.5 months
Title
Feasibility - Surveys
Description
Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.
Time Frame
3.5 months
Secondary Outcome Measure Information:
Title
Child Body Mass Index Z-Score
Description
Measure child's height and weight. Enter into the Children's Hospital Of Philadelphia Body Mass Index calculator.
Time Frame
Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Title
Parent Body Mass Index
Description
Measure parent's height and weight. Enter into the Centers for Disease Control adult Body Mass Index calculator.
Time Frame
Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Title
Parent Subjective Executive Function
Description
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.
Time Frame
Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Title
Child Subjective Executive Function
Description
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.
Time Frame
Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Title
Parent Behavioral Functioning - Anxiety
Description
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.
Time Frame
Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Title
Parent Behavioral Functioning - Depression
Description
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.
Time Frame
Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Title
Child Behavioral Functioning - Overall
Description
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.
Time Frame
Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Other Pre-specified Outcome Measures:
Title
Child Physical Activity Behavior
Description
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.
Time Frame
Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Title
Child Eating Behavior
Description
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.
Time Frame
Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Title
Impact of the Food Environment
Description
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.
Time Frame
Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Title
Child Psychological Flexibility - Acceptance
Description
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.
Time Frame
Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Title
Child Psychological Flexibility - Mindfulness
Description
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.
Time Frame
Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Title
Parent Psychological Flexibility
Description
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.
Time Frame
Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Title
Demographics
Description
Child and caregiver characteristics such as age, sex, race/ethnicity, educational level, family income, and marital status will be assessed via caregiver report.
Time Frame
Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Title
Participant Satisfaction - Interviews
Description
Semi-structured group interviews will assess caregiver and child experiences with the program.
Time Frame
3.5 months
Title
Participant Satisfaction - Surveys
Description
Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.
Time Frame
3.5 months
Title
Adherence
Description
Number of Sessions Attended
Time Frame
3.5 months
Title
Child Health Related Quality of Life - Self Report
Description
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.
Time Frame
Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Title
Child Health Related Quality of Life - Parent Report
Description
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.
Time Frame
Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children who: have a BMI ≥ 85th percentile; are 8 and 14 years old at the beginning of treatment; can read, write, and speak English, along with their caregiver; plan to stay living in the local area during the study period; have a consenting caregiver who can commit to all study procedures. Exclusion Criteria: Children who: have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight, physical activity level or executive function; are currently participating in a formal weight management program beyond usual medical care or have a caregiver participating in a formal weight management program.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marissa A Gowey, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Due to the small sample size and risk of confidentiality loss, there is no plan to share IPD.
Links:
URL
http://www.reachlabresearch.com
Description
Dr. Marissa Gowey's Research of Eating and Activity for Child Health (REACH) Lab focuses on identifying modifiable factors that are associated with response to treatment for obesity.

Learn more about this trial

Virtual Health Focused Acceptance-Based Program for Parents and Youth

We'll reach out to this number within 24 hrs