Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention

Weight Loss Clinical Trial

Official title:

Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304249
• Other study ID #: iAmHealthy 2
• Secondary ID: R01NR016255-01A1
• Status: Completed
• Phase: N/A
• Start date: October 13, 2017
• Est. completion date: June 20, 2022

Study information

• Verified date: September 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: June 20, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Obesity
• Weight Loss

Intervention

Behavioral:
• iAmHealthy Healthy Lifestyles Program
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.

Other:
• Newsletter
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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Parent Body Mass Index (BMI)	Parent BMI was calculated at three time points.	Baseline, Month 8, Month 20