Clinical trial NCT03304249: Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention
Official title: Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2017-10-06
Enrollment: 296
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Child Body Mass Index Z-score (BMIz) at Baseline and Month 8
timeFrame: Baseline to Month 8
Secondary outcomes:
measure: Child Body Mass Index Z-score (BMIz) at Baseline and Month 20
timeFrame: Baseline to Month 20
measure: Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day
timeFrame: Baseline, Month 8, Month 20
measure: Physical Activity - % Time in Sedentary Activity
timeFrame: Baseline, Month 8, Month 20
measure: Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables
timeFrame: Baseline, Month 8, Month 20
measure: Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages
timeFrame: Baseline, Month 8, Month 20
measure: Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of "Red Foods" (Foods High in Sugar and/or Fat)
timeFrame: Baseline, Month 8, Month 20
measure: Parent Body Mass Index (BMI)
timeFrame: Baseline, Month 8, Month 20
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Ann M Davis, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forseth B, Davis AM, Bakula DM, Murray M, Dean K, Swinburne Romine RE, Fleming K. Validation of remote height and weight assessment in a rural randomized clinical trial. BMC Med Res Methodol. 2022 Jul 11;22(1):185. doi: 10.1186/s12874-022-01669-8.
citation: Davis AM, Beaver G, Dreyer Gillette M, Nelson EL, Fleming K, Swinburne Romine R, Sullivan DK, Lee R, Pettee Gabriel K, Dean K, Murray M, Faith M. iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children. Contemp Clin Trials. 2019 Mar;78:20-26. doi: 10.1016/j.cct.2019.01.001. Epub 2019 Jan 7.