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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | 12 week virtual family-based health eating program |
|
| Comparison | No Intervention | Standard in-office counseling about diet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Inclusion criteria include:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthWorks for Northern Virginia | Leesburg | Virginia | 20176 | United States |
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None. All participants enrolled were assigned to a group.
Recruitment Occurred between 08/18/2022 and 10/10/2022
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | 12 week virtual family-based health eating program 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. |
| FG001 | Comparison | Standard in-office counseling about diet |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | 12 week virtual family-based health eating program 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Count of Participants | Participants | 3 months post-study intervention |
|
Adverse Events were monitored over 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | 12 week virtual family-based health eating program 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elyssa Wood | Inova Health System | 5714728649 | elyssa.wood@inova.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2022 | Feb 13, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 31, 2022 | Feb 7, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 |
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concurrent groups
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|
| BG001 | Comparison | Standard in-office counseling about diet, physical activity and screen time |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 12 Withdrew from the study, 3 lost to Follow-Up | Count of Participants | Participants |
|
| Race (NIH/OMB) | 12 Withdrew, 3 Lost to Follow-Up | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Comparison | Standard in-office counseling about diet, physical activity and screen time |
|
|
|
| Primary | 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) | Posted | Count of Participants | Participants | 3 months post-study intervention |
|
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Comparison | Standard in-office counseling about diet | 0 | 16 | 0 | 16 | 0 | 16 |
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| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|