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

NCT05419557 | Completed Results

• 1 other identifier: U21-12-4630
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Behavior; Diet, Healthy; Childhood Obesity

Outcome Measures

Primary Outcomes (2)

• Count of Participants Who Consumed Vegetables With Their Dinner Meal More Than 5 Days Per Week

  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)

  3 months post-study intervention

• Count of Guardians Who Reported Being Confident or Very Confident That They Could Increase the Number of Vegetables the Child Eats Each Week

  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)

  3 months post-study intervention

Study Arms (2)

Intervention

ACTIVE COMPARATOR

12 week virtual family-based health eating program

Behavioral: Virtual Family-Based Healthy Plate Club

Comparison

NO INTERVENTION

Standard in-office counseling about diet

Interventions

Virtual Family-Based Healthy Plate Club BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

HealthWorks for Northern Virginia

Leesburg, Virginia, 20176, United States

Location

MeSH Terms

Conditions

Health Behavior; Pediatric Obesity

Condition Hierarchy (Ancestors)

Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study relied on self-reported measures of behaviors, which are subject to recall bias and social desirability bias and in addition we relied on reports from guardians about their child. The study had a relatively short follow-up period limiting our understanding of the long-term sustainability of intervention. The study sample was limited to a specific cultural group, which limits the generalizability of the findings to other cultural contexts.

Results Point of Contact

• Title: Dr. Elyssa Wood
• Organization: Inova Health System

elyssa.wood@inova.org

5714728649

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: concurrent groups

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 15, 2022
• Study Start: August 17, 2022
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)