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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Health Behavior, Diet, Healthy, Childhood Obesity

Intervention / Treatment
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* Behavioral: Virtual Family-Based Healthy Plate Club


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: concurrent groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>12 week virtual family-based health eating program | Behavioral: Virtual Family-Based Healthy Plate Club<br>* IHPC provides produce boxes, nutrition and meal-preparation, education, and supportive counseling to address barriers related to obtaining produce and food. The intervention provides participants with a bi-weekly produce box for 12 weeks and helps families identify sustainable ways to obtain vegetables once the produce boxes end. The CHW will support families by coaching them on how to prepare these unfamiliar vegetables, give tips on finding sales at grocery stores, as well as by navigation to food assistance sites including food pantries. Parents will learn strategies to increase vegetable consumption by addressing perceived barriers - such as the child doesn't like vegetables. Curriculum will also include topics such as how to increase physical activity and reduce screen time.<br>|
| No Intervention: Comparison<br>Standard in-office counseling about diet | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NHANES food frequency questionnaire | measures food consumption and type | 3 months | 
| Healthy Home Survey | screen time estimates and types | 3 months | 
| Healthy Home Survey | physical activity questionnaire measures amount and type of physical activity | 3 months | 
| Self-Efficacy scale | guardian self-efficacy and confidence questions related to modifiable lifestyle behaviors | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | BMI | 3 months |