Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention

Study Overview
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Brief Summary
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The purpose of this study is to learn if providing a family-based group program using mobile health technology (iAmHealthy Healthy Lifestyles Program) is effective at improving child weight, nutrition, and physical activity.

Detailed Description
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This is a cluster-randomized study that will test the iAmHealthy Healthy Lifestyles Program versus a standard approach to weight loss in kids current in 2nd thru 4th grade. The iAmHealthy Healthy Lifestyles Program utilizes mobile tools to deliver the weight loss program to kids and families in rural settings. This study will include kids from schools in rural cities/counties, and their parents, and they will be randomly assigned to a group by their school. The iAmHealthy Healthy Lifestyles Program is a rurally tailored telemedicine intervention. It delivers behavioral, nutritional, and physical activity topics for kids and their families. The total length of the intervention will be about 8 months, which coincides with the length of a typical school year.

Official Title
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Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention

Conditions
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Weight Loss

Intervention / Treatment
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* Behavioral: iAmHealthy Healthy Lifestyles Program
* Other: Newsletter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Family lives in a rural area (city and/or county population less than 20,000) Child Body Mass Index (BMI) >85th and <99th percentile Child in 2nd thru 4th grade Child and Parent speak English Family is available at times intervention is offered Exclusion Criteria: Child has physical limitation or receives an injury which significantly limits physical mobility Child has significant medical issue Child and Parents have significant developmental delay or cognitive impairment Child has a sibling who has already enrolled in the program Family moves to a non-participating school

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iAmHealthy<br>Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program. | Behavioral: iAmHealthy Healthy Lifestyles Program<br>* iAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions.<br>|
| Active Comparator: Control<br>Participants randomized to this group receive comparable content delivered via a newsletter. | Other: Newsletter<br>* Weight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Body Mass Index Z-score (BMIz) at Baseline and Month 8 | Body mass index z-score (BMIz) is the age and sex standardized body mass index for children. To calculate BMIz, the equation BMIz = [(BMI/M)^L - 1] ÷ (L × S) is used where M is the median, L is the power transformation to achieve normality, and S is the coefficient of variation. A z-score of 0 represents the historical population norm. A higher BMIz is indicative of higher fat mass. | Baseline to Month 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Body Mass Index Z-score (BMIz) at Baseline and Month 20 | Body mass index z-score (BMIz) is the age and sex standardized body mass index for children. To calculate BMIz, the equation BMIz = [(BMI/M)^L - 1] ÷ (L × S) is used where M is the median, L is the power transformation to achieve normality, and S is the coefficient of variation. A z-score of 0 represents the historical population norm. A higher BMIz is indicative of higher fat mass. | Baseline to Month 20 | 
| Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day | Measured using ActiGraph physical activity monitors. Outcome will be calculated as the average (across valid wear days) time spent per day in moderate to vigorous physical activity (MVPA). | Baseline, Month 8, Month 20 | 
| Physical Activity - % Time in Sedentary Activity | Measured using ActiGraph physical activity monitors. Outcome was calculated as the percentage of time time spent in sedentary activity compared to wear time. | Baseline, Month 8, Month 20 | 
| Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables | The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance. | Baseline, Month 8, Month 20 | 
| Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages | The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance/ | Baseline, Month 8, Month 20 | 
| Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Red Foods (Foods High in Sugar and/or Fat) | The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance. | Baseline, Month 8, Month 20 | 
| Parent Body Mass Index (BMI) | Parent BMI was calculated at three time points. | Baseline, Month 8, Month 20 |