Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention

Not Applicable

Completed

Conditions: Weight Loss

Interventions: Other: Newsletter
Behavioral: iAmHealthy Healthy Lifestyles Program

Registration Number: NCT03304249

Lead Sponsor: University of Kansas Medical Center

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 296

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Newsletter	Participants randomized to this group receive comparable content delivered via a newsletter.
iAmHealthy	iAmHealthy Healthy Lifestyles Program	Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.

Primary Outcome Measures

Name	Time	Method
Child Body Mass Index Z-score (BMIz) at Baseline and Month 8	Baseline to 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.

Secondary Outcome Measures

Name	Time	Method
Child Body Mass Index Z-score (BMIz) at Baseline and Month 20	Baseline to 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.
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages	Baseline, Month 8, Month 20	The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance/
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of "Red Foods" (Foods High in Sugar and/or Fat)	Baseline, Month 8, Month 20	The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.
Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day	Baseline, Month 8, Month 20	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).
Physical Activity - % Time in Sedentary Activity	Baseline, Month 8, Month 20	Measured using ActiGraph physical activity monitors. Outcome was calculated as the percentage of time time spent in sedentary activity compared to wear time.
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables	Baseline, Month 8, Month 20	The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.
Parent Body Mass Index (BMI)	Baseline, Month 8, Month 20	Parent BMI was calculated at three time points.