Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention

September 5, 2023 updated by: University of Kansas Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

296

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iAmHealthy
Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.
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.
Active Comparator: Control
Participants randomized to this group receive comparable content delivered via a newsletter.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Body Mass Index Z-score (BMIz) at Baseline and Month 8
Time Frame: 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.
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
Time Frame: 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.
Baseline to Month 20
Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day
Time Frame: 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).
Baseline, Month 8, Month 20
Physical Activity - % Time in Sedentary Activity
Time Frame: 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.
Baseline, Month 8, Month 20
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables
Time Frame: 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.
Baseline, Month 8, Month 20
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages
Time Frame: 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/
Baseline, Month 8, Month 20
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of "Red Foods" (Foods High in Sugar and/or Fat)
Time Frame: 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.
Baseline, Month 8, Month 20
Parent Body Mass Index (BMI)
Time Frame: Baseline, Month 8, Month 20
Parent BMI was calculated at three time points.
Baseline, Month 8, Month 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Ann M Davis, PhD, MPH, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2017

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

June 20, 2022

Study Registration Dates

First Submitted

September 28, 2017

First Submitted That Met QC Criteria

October 2, 2017

First Posted (Actual)

October 6, 2017

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iAmHealthy 2
  • R01NR016255-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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