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OpenTrials
Completed

NCT Number: NCT03304249

Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iAmHealthy Healthy Lifestyles Program

Behavioral

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.

Newsletter

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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/

  6. 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.

  7. Parent Body Mass Index (BMI)

    Time frame: Baseline, Month 8, Month 20

    Parent BMI was calculated at three time points.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Oct 6, 2017
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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