Buen Provecho!: A Virtual Family-Based Intervention to Promote Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Count of Participants Who Consumed Vegetables With Their Dinner Meal More Than 5 Days Per Week
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Count of Participants Who Consumed Vegetables With Their Dinner Meal More Than 5 Days Per Week
时间窗: 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
时间窗: 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)
次要结局
未报告次要终点