Buen Provecho!: A Virtual Family-Based Intervention to Promote Health
Primary Purpose
Health Behavior, Diet, Healthy, Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Family-Based Healthy Plate Club
Sponsored by
About this trial
This is an interventional prevention trial for Health Behavior
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria include:
- Both Guardian and Child are clients at community clinic
- Child between the ages 6-10 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.
Sites / Locations
- HealthWorks for Northern Virginia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention
Comparison
Arm Description
12 week virtual family-based health eating program
Standard in-office counseling about diet
Outcomes
Primary Outcome Measures
NHANES food frequency questionnaire
measures food consumption and type
Healthy Home Survey
screen time estimates and types
Healthy Home Survey
physical activity questionnaire measures amount and type of physical activity
Self-Efficacy scale
guardian self-efficacy and confidence questions related to modifiable lifestyle behaviors
Secondary Outcome Measures
BMI
BMI
Full Information
NCT ID
NCT05419557
First Posted
June 10, 2022
Last Updated
February 13, 2023
Sponsor
Inova Health Care Services
1. Study Identification
Unique Protocol Identification Number
NCT05419557
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Behavior, Diet, Healthy, Childhood Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
concurrent groups
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
12 week virtual family-based health eating program
Arm Title
Comparison
Arm Type
No Intervention
Arm Description
Standard in-office counseling about diet
Intervention Type
Behavioral
Intervention Name(s)
Virtual Family-Based Healthy Plate Club
Intervention Description
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.
Primary Outcome Measure Information:
Title
NHANES food frequency questionnaire
Description
measures food consumption and type
Time Frame
3 months
Title
Healthy Home Survey
Description
screen time estimates and types
Time Frame
3 months
Title
Healthy Home Survey
Description
physical activity questionnaire measures amount and type of physical activity
Time Frame
3 months
Title
Self-Efficacy scale
Description
guardian self-efficacy and confidence questions related to modifiable lifestyle behaviors
Time Frame
3 months
Secondary Outcome Measure Information:
Title
BMI
Description
BMI
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
HealthWorks for Northern Virginia
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Buen Provecho!: A Virtual Family-Based Intervention to Promote Health
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