Clinical trial NCT04634045: Virtual Health Focused Acceptance-Based Program for Parents and Youth
Official title: Targeting Self-Regulation in Family-Based Behavioral Treatment for Obesity and Cardiovascular Disease Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Executive Function
Keywords: Pediatric Obesity
Executive Function
Behavioral Intervention
Acceptance Based
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Childrens of Alabama Kaul Pediatric Research Institute
First posted: 2020-11-18
Enrollment: 19
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability - Interviews
timeFrame: 3.5 months
measure: Acceptability - Surveys
timeFrame: 3.5 months
measure: Feasibility - Interviews
timeFrame: 3.5 months
measure: Feasibility - Surveys
timeFrame: 3.5 months
Secondary outcomes:
measure: Child Body Mass Index Z-Score
timeFrame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
measure: Parent Body Mass Index
timeFrame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
measure: Parent Subjective Executive Function
timeFrame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
measure: Child Subjective Executive Function
timeFrame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
measure: Parent Behavioral Functioning - Anxiety
timeFrame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
measure: Parent Behavioral Functioning - Depression
timeFrame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
measure: Child Behavioral Functioning - Overall
timeFrame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Other outcomes:
measure: Child Physical Activity Behavior
timeFrame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
measure: Child Eating Behavior
timeFrame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
measure: Impact of the Food Environment
timeFrame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
measure: Child Psychological Flexibility - Acceptance
timeFrame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
measure: Child Psychological Flexibility - Mindfulness
timeFrame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
measure: Parent Psychological Flexibility
timeFrame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
measure: Demographics
timeFrame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
measure: Participant Satisfaction - Interviews
timeFrame: 3.5 months
measure: Participant Satisfaction - Surveys
timeFrame: 3.5 months
measure: Adherence
timeFrame: 3.5 months
measure: Child Health Related Quality of Life - Self Report
timeFrame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
measure: Child Health Related Quality of Life - Parent Report
timeFrame: Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Marissa A Gowey, PhD
role: PRINCIPAL_INVESTIGATOR
References: