Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention

NCT ID: NCT03304249

Last Updated: 2023-09-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-13

Study Completion Date

2022-06-20

Brief Summary

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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

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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.

Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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iAmHealthy

Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.

Group Type EXPERIMENTAL

iAmHealthy Healthy Lifestyles Program

Intervention Type 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.

Control

Participants randomized to this group receive comparable content delivered via a newsletter.

Group Type ACTIVE_COMPARATOR

Newsletter

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ann M Davis, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

References

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Lancaster B, Goldenberg E, Trofimoff AS, Dai Y, Forseth B, Romine RS, Fleming K, Davis A. Mental health outcomes of a pediatric-focused obesity randomized control trial in rural communities. Health Psychol. 2025 May 29:10.1037/hea0001518. doi: 10.1037/hea0001518. Online ahead of print.

Reference Type DERIVED
PMID: 40440117 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35818033 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30630108 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01NR016255-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

iAmHealthy 2

Identifier Type: -

Identifier Source: org_study_id

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