Virtual Health Focused Acceptance-Based Program for Parents and Youth

Not Applicable

Completed

• Conditions: Executive Function; Pediatric Obesity
• Interventions: Behavioral: Web Based Treatment

• Registration Number: NCT04634045
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-11
• Study First Posted: 2020-11-18
• Study Start: 2021-08-01
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Web-Based Treatment	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Child Subjective Executive Function	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)	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 - Depression	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)	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	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)	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.
Parent Body Mass Index	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)	Measure parent's height and weight. Enter into the Centers for Disease Control adult Body Mass Index calculator.
Parent Behavioral Functioning - Anxiety	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)	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.
Child Body Mass Index Z-Score	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)	Measure child's height and weight. Enter into the Children's Hospital Of Philadelphia Body Mass Index calculator.
Parent Subjective Executive Function	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States