Clinical trial NCT05419557: Buen Provecho!: A Virtual Family-Based Intervention to Promote Health
Official title: Buen Provecho!: A Virtual Family-Based Intervention to Promote Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Diet, Healthy
Childhood Obesity
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: concurrent groups
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria include:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Count of Participants Who Consumed Vegetables With Their Dinner Meal More Than 5 Days Per Week
timeFrame: 3 months post-study intervention
measure: Count of Guardians Who Reported Being Confident or Very Confident That They Could Increase the Number of Vegetables the Child Eats Each Week
timeFrame: 3 months post-study intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Leesburg
country: United States
facility: HealthWorks for Northern Virginia
state: Virginia
Study officials:
References: