Virtual Health Focused Acceptance-Based Program for Parents and Youth

NCT04634045 | Completed

• 1 other identifier: 300005967
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity; Executive Function

Keywords

Pediatric Obesity; Executive Function; Behavioral Intervention; Acceptance Based

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Child Body Mass Index Z-Score

  Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)

• Parent Body Mass Index

  Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)

• Parent Subjective Executive Function

  Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)

• Child Subjective Executive Function

  Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)

• Parent Behavioral Functioning - Anxiety

  Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)

Other Outcomes (12)

• Child Physical Activity Behavior

  Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)

• Child Eating Behavior

  Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)

• Impact of the Food Environment

  Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)

Study Arms (1)

Web-Based Treatment

EXPERIMENTAL

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

Interventions

Web Based Treatment BEHAVIORAL

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.

Also known as: Acceptance-Based Treatment

Web-Based Treatment

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Childrens of Alabama Kaul Pediatric Research Institute: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35209, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marissa A Gowey, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 18, 2020
• Study Start: August 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)