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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05419557
• Other study ID #: U21-12-4630
• Status: Completed
• Phase: N/A
• Start date: August 17, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Obesity
• Diet, Healthy
• Health Behavior
• Pediatric Obesity

Intervention

Behavioral:
• Virtual Family-Based Healthy Plate Club
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.

Locations

Country	Name	City	State
United States	HealthWorks for Northern Virginia	Leesburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NHANES food frequency questionnaire	measures food consumption and type	3 months
Primary	Healthy Home Survey	screen time estimates and types	3 months
Primary	Healthy Home Survey	physical activity questionnaire measures amount and type of physical activity	3 months
Primary	Self-Efficacy scale	guardian self-efficacy and confidence questions related to modifiable lifestyle behaviors	3 months
Secondary	BMI	BMI	3 months