Targeting Self-Regulation in Family-Based Behavioral Treatment for Obesity and Cardiovascular Disease Prevention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- Feasibility - Interviews
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Feasibility - Interviews
Time Frame: 3.5 months
Semi-structured group interviews will assess caregiver and child experiences with the program.
Feasibility - Surveys
Time Frame: 3.5 months
Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.
Acceptability - Interviews
Time Frame: 3.5 months
Semi-structured group interviews will assess caregiver and child experiences with the program.
Acceptability - Surveys
Time Frame: 3.5 months
Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.
Secondary Outcomes
- Child Subjective Executive Function(Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks))
- Parent Behavioral Functioning - Depression(Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks))
- Child Behavioral Functioning - Overall(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 Behavioral Functioning - Anxiety(Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks))
- Child Body Mass Index Z-Score(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))
Investigators
Marissa Gowey
Assistant Professor
University of Alabama at Birmingham