Virtual Health Focused Acceptance-Based Program for Parents and Youth

Pediatric Obesity Clinical Trial

— vHAPPY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04634045
• Other study ID #: 300005967
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: August 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Executive Function
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Web Based Treatment
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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Childrens of Alabama Kaul Pediatric Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child Physical Activity Behavior	Physical Activity Questionnaire - Child. A self-administered, 7 day recall instrument developed to assess general levels of physical activity in children approximately 8-14 years of age. Provides a summary physical activity score derived from nine items, each scored on a 5 point scale.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Other	Child Eating Behavior	Children's Eating Behavior Questionnaire. A 35-item parent proxy-report measure of eating behavior producing 8 subscales: responsiveness to food, enjoyment of food, satiety responsiveness, slowness in eating, fussiness, emotional overeating, emotional undereating, desire for drinks. Items are scored on a 5-point Likert scale and the mean score of each subscale is used. Higher scores indicate more eating behaviors in a certain domain.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Other	Impact of the Food Environment	Power of Food Scale. A 15-item self-report assessment of the psychological impact of living in food-abundant environments. Items are rated on a 5-point Likert scale and summed to create a total score. Higher scores reflect greater responsiveness to the food environment.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Other	Child Psychological Flexibility - Acceptance	Acceptance Fusion Questionnaire for Youth. A 17-item self-report measure for to assess psychological inflexibility in children. Items are scored on a 5-point Likert scale and summed for a total score ranging between 0-68. Higher scores are indicative of greater psychological inflexibility.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Other	Child Psychological Flexibility - Mindfulness	Child and Adolescent Mindfulness Measure. A 10-item measure of children's awareness and acceptance of their own private events or internal experiences. Items are reverse scored on a 5-point Likert scale. Higher scores correspond to higher levels of mindfulness.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Other	Parent Psychological Flexibility	Parental Acceptance and Action Questionnaire. A 15-item measure that evaluates parents' experiential acceptance and action tendencies in the context of their relationship with their children. The Total score is used which is a sum of all items which are rated on a 7-point Likert scale. Higher scores represent a greater degree of parental experiential avoidance.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Other	Demographics	Child and caregiver characteristics such as age, sex, race/ethnicity, educational level, family income, and marital status will be assessed via caregiver report.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Other	Participant Satisfaction - Interviews	Semi-structured group interviews will assess caregiver and child experiences with the program.	3.5 months
Other	Participant Satisfaction - Surveys	Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.	3.5 months
Other	Adherence	Number of Sessions Attended	3.5 months
Other	Child Health Related Quality of Life - Self Report	Sizing Me Up©. A validated obesity-specific self-report measure, respectively, of health-related quality of life for children 5-13 years old that measure functioning in a variety of areas (e.g., emotional, physical, teasing/marginalization). The Total Score will be used as the outcome, which is a scaled score ranging from 0-100 with higher scores representing better quality of life.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Other	Child Health Related Quality of Life - Parent Report	Sizing Them Up©. A validated obesity-specific parent-report measure, respectively, of health-related quality of life for children 5-13 years old that measure functioning in a variety of areas (e.g., emotional, physical, teasing/marginalization). The Total Score will be used as the outcome, which is a scaled score ranging from 0-100 with higher scores representing better quality of life.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Primary	Acceptability - Interviews	Semi-structured group interviews will assess caregiver and child experiences with the program.	3.5 months
Primary	Acceptability - Surveys	Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.	3.5 months
Primary	Feasibility - Interviews	Semi-structured group interviews will assess caregiver and child experiences with the program.	3.5 months
Primary	Feasibility - Surveys	Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.	3.5 months
Secondary	Child Body Mass Index Z-Score	Measure child's height and weight. Enter into the Children's Hospital Of Philadelphia Body Mass Index calculator.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Secondary	Parent Body Mass Index	Measure parent's height and weight. Enter into the Centers for Disease Control adult Body Mass Index calculator.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Secondary	Parent Subjective Executive Function	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.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Secondary	Child Subjective Executive Function	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.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Secondary	Parent Behavioral Functioning - Anxiety	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.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Secondary	Parent Behavioral Functioning - Depression	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.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)
Secondary	Child Behavioral Functioning - Overall	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.	Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks)