An interventional study of Virtual Family-Based Healthy Plate Club in Health Behavior, Diet, Healthy and Childhood Obesity, sponsored by Inova Health Care Services. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Inova Health Care Services · Not applicable, Interventional, and Prevention
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.
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.
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's enrollment of 42 is below the median of 103 across 862 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Inova Health Care Services is the lead sponsor of 84 studies on the registry; 20 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
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Inclusion Criteria:
Inclusion criteria include:
Exclusion Criteria:
12 week virtual family-based health eating program
Behavioral: Virtual Family-Based Healthy Plate Club
Standard in-office counseling about diet
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.
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)
Time frame: 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)
Time frame: 3 months post-study intervention
Recruitment Occurred between 08/18/2022 and 10/10/2022
| Milestone | Intervention | Comparison |
|---|---|---|
| Started | 22 | 20 |
| Completed | 11 | 16 |
| Not completed | 11 | 4 |
| Withdrew: Lost to follow-up | 11 | 4 |
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)
| Participants | Intervention | Comparison |
|---|---|---|
| Count of Participants Who Consumed Vegetables With Their Dinner Meal More Than 5 Days Per Week | 9 | 5 |
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)
| Participants | Intervention | Comparison |
|---|---|---|
| Count of Guardians Who Reported Being Confident or Very Confident That They Could Increase the Number of Vegetables the Child Eats Each Week | 7 | 5 |
Collected over Adverse Events were monitored over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Comparison | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Age, Categorical(Participants) | Intervention | Comparison | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 22 | 20 | 42 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Intervention | Comparison | Total |
|---|---|---|---|
| Female | 22 | 20 | 42 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Intervention | Comparison | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 14 | 24 |
| Not Hispanic or Latino | 1 | 2 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention | Comparison | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 11 | 15 | 26 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Intervention | Comparison | Total |
|---|---|---|---|
| United States | 22 | 20 | 42 |
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