Buen Provecho!: A Virtual Family-Based Intervention to Promote Health

Not Applicable

Completed

Conditions: Diet, Healthy
Childhood Obesity
Health Behavior

Interventions: Behavioral: Virtual Family-Based Healthy Plate Club

Registration Number: NCT05419557

Lead Sponsor: Inova Health Care Services

Brief Summary: The purpose of this pilot study is to compare the effectiveness of an expanded virtual educational program at modifying knowledge, self-efficacy, and behaviors when compared to traditional in-office counseling for guardians of children who are obese or overweight.

Detailed Description: Rationale: Obesity rates are significantly higher among Hispanic youth in the United States, disproportionately putting these children at an increased risk for obesity-related diseases such as hypertension, dyslipidemia, and impaired glucose tolerance. While virtual programming offers an innovative option for pediatric weight management, limited data exists on the efficacy of virtual interventions for this population and their guardians (parents / caregivers).

Objectives: The purpose of this pilot study is to compare the effectiveness of an expanded virtual educational program (expanded -Inova Healthy Plate Club, x-IHPC) at modifying knowledge, self-efficacy, and behaviors when compared to traditional in-office counseling for guardians of children who are obese or overweight.

Study Design: In order to test the effectiveness of the x-IHPC intervention, outcomes from participants in this pilot study will be compared with outcomes from a comparison group of similar participants who receive standard nutrition counseling during their regularly scheduled check-ups. The team will enroll 25 children in the x-IHPC intervention and the same number in the comparison group (n=50). Both groups will receive standard in-office counseling, but the intervention group will also receive the x-IHPC.

Study Methodology: The comparison group receives standard, in-office counseling at visits 1, 3-months and 6-months. The intervention group receives standard in-office counseling at the same intervals, and also participates in a 12-week x-IHPC developed by a dietician curriculum specialist. In addition, a key pillar of this study is identifying and training Community Health Workers (CHWs) to be Spanish-speaking facilitators of the x-IHPC and utilizing community engagement strategies. Training these CHWs and including them in designing the x-IHPC curriculum, will ensure that the programming is culturally appropriate; includes local features that relate directly to the community's needs; and enables study facilitators to respond effectively to the questions and learning needs of the parents and children involved in the program.

Statistical Methodology:

To examine the research question, a longitudinal analysis using generalized estimating equations (GEE) will be conducted to assess if mean differences exist on dietary measures, screen time, sleep quality, physical activity and guardian self-efficacy and confidence between the intervention and comparison groups while accounting for the correlation among the repeated measurements and controlling for covariates.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 42

Inclusion Criteria

Inclusion criteria include:

Child is clients at community clinic
Child between the ages 6-12 years
Child has a BMI percentage greater than 85%
Primary parent or guardian is > 18 years of age
Family identifies as Hispanic and Spanish is one of the primary languages spoken in the home
Children will be living with the primary guardian or parent for the duration of the program
Access to the internet
Parent or guardian is willing to commit to engaging in the 12 week program

Exclusion Criteria

Family plans to change location within the year
During initial screening for the study, the study PI determines that the intervention may exacerbate existing medical conditions of the child or the family.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Virtual Family-Based Healthy Plate Club	12 week virtual family-based health eating program

Primary Outcome Measures

Name	Time	Method
Count of Participants Who Consumed Vegetables With Their Dinner Meal More Than 5 Days Per Week	3 months post-study intervention	Days per week child ate vegetables with dinner meal, post intervention Measured with a food frequency questionnaire, question: "Think about all the foods your child ate at your dinner/supper meal and snacks in the past week. On how many days did your child eat vegetables for the dinner meal?" Answer options: 1, Never \\| 2, 1-3 days \\| 3, 1-2 days \\| 4, 3-4 days \\| 5, 5-6 days \\| 6, Every day (Higher score indicates increased vegetable consumption)
Count of Guardians Who Reported Being Confident or Very Confident That They Could Increase the Number of Vegetables the Child Eats Each Week	3 months post-study intervention	Guardians who reported being Confident or Very Confident that they could increase the number of vegetables the child eats each week As measured by guardian self-efficacy and confidence questions related to modifiable lifestyle behaviors on a likert scale Question: How confident do you feel that you can increase the number of vegetables your child eats each week? Likert Scale: 1, Not confident = It is impossible for me to do this \\| 2, Somewhat confident = Maybe I can do this \\| 3, Confident = I think I can do this \\| 4, Very confident = I can absolutely do this (Higher score indicates better outcome than lower score on Likert scale)

Secondary Outcome Measures