Childhood Obesity, Diet, Healthy, Health Behavior
Conditions
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.
Interventions
BEHAVIORALVirtual 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.
Sponsors
Inova Health Care Services
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
concurrent groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants Who Consumed Vegetables With Their Dinner Meal More Than 5 Days Per Week | 3 months post-study intervention | 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) |
| Count of Guardians Who Reported Being Confident or Very Confident That They Could Increase the Number of Vegetables the Child Eats Each Week | 3 months post-study intervention | 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) |
Countries
United States
Participant flow
Recruitment details
Recruitment Occurred between 08/18/2022 and 10/10/2022
Pre-assignment details
None. All participants enrolled were assigned to a group.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| Comparison Standard in-office counseling about diet, physical activity and screen time | 20 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 4 |
Baseline characteristics
| Characteristic | Intervention | Comparison | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 20 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 14 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 15 Participants | 26 Participants |
| Region of Enrollment United States | 22 Participants | 20 Participants | 42 Participants |
| Sex: Female, Male Female | 22 Participants | 20 Participants | 42 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 16 |
| other Total, other adverse events | 0 / 11 | 0 / 16 |
| serious Total, serious adverse events | 0 / 11 | 0 / 16 |
Outcome results
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)
Time frame: 3 months post-study intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Count of Guardians Who Reported Being Confident or Very Confident That They Could Increase the Number of Vegetables the Child Eats Each Week | 7 Participants |
| Comparison | Count of Guardians Who Reported Being Confident or Very Confident That They Could Increase the Number of Vegetables the Child Eats Each Week | 5 Participants |
p-value: 0.01595% CI: [1.55, 64.25]Regression, Logistic
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)
Time frame: 3 months post-study intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Count of Participants Who Consumed Vegetables With Their Dinner Meal More Than 5 Days Per Week | 9 Participants |
| Comparison | Count of Participants Who Consumed Vegetables With Their Dinner Meal More Than 5 Days Per Week | 5 Participants |
p-value: 0.0295% CI: [1.3, 54.6]Regression, Logistic