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Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention

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ClinicalTrials.gov Identifier: NCT03304249
Recruitment Status : Recruiting
First Posted : October 6, 2017
Last Update Posted : January 31, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Weight Loss Behavioral: iAmHealthy Healthy Lifestyles Program Other: Newsletter Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention
Actual Study Start Date : October 13, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in Child Body Mass Index z Score (BMIz) [ Time Frame: Change from Baseline to Month 8 ]

Secondary Outcome Measures :
  1. Change in Child Body Mass Index z Score (BMIz) [ Time Frame: Change from Baseline to Month 20 ]
  2. Physical activity - average time [ 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 [ Time Frame: Baseline, Month 8, Month 20 ]
    Measured using ActiGraph physical activity monitors. Outcome will be calculated as the percentage of time time spent per day in MVPA.

  4. Photo-assisted 24 hour food recall (24hr FR) [ 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. Parent Body Mass Index (BMI) [ Time Frame: Baseline, Month 8, Month 20 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304249


Contacts
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Contact: Kelsey Dean, RD 913-588-3775 kdean@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Ann M Davis, PhD, MPH, ABPP University of Kansas Medical Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03304249     History of Changes
Other Study ID Numbers: iAmHealthy 2
R01NR016255-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 6, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pediatric Obesity
Weight Loss
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes