Clinical Trials Directory

Trials / Completed

CompletedNCT04634045

Virtual Health Focused Acceptance-Based Program for Parents and Youth

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
19 (actual)
Sponsor
University of Alabama at Birmingham · Academic / Other
Sex
All
Age
8 Years – 14 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALWeb Based TreatmentThe 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.

Timeline

Start date
2021-08-01
Primary completion
2022-02-28
Completion
2022-02-28
First posted
2020-11-18
Last updated
2022-08-31

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04634045. Inclusion in this directory is not an endorsement.