Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention
Primary Purpose
Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iAmHealthy Healthy Lifestyles Program
Newsletter
Sponsored by
About this trial
This is an interventional prevention trial for Weight Loss
Eligibility 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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
iAmHealthy
Control
Arm Description
Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.
Participants randomized to this group receive comparable content delivered via a newsletter.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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.
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/
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.
Parent Body Mass Index (BMI)
Parent BMI was calculated at three time points.
Full Information
NCT ID
NCT03304249
First Posted
September 28, 2017
Last Updated
September 5, 2023
Sponsor
University of Kansas Medical Center
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT03304249
Brief Title
Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention
Official Title
Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 13, 2017 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
June 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
296 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iAmHealthy
Arm Type
Experimental
Arm Description
Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants randomized to this group receive comparable content delivered via a newsletter.
Intervention Type
Behavioral
Intervention Name(s)
iAmHealthy Healthy Lifestyles Program
Intervention Description
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
Other
Intervention Name(s)
Newsletter
Intervention Description
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 Measure Information:
Title
Child Body Mass Index Z-score (BMIz) at Baseline and Month 8
Description
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.
Time Frame
Baseline to Month 8
Secondary Outcome Measure Information:
Title
Child Body Mass Index Z-score (BMIz) at Baseline and Month 20
Description
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.
Time Frame
Baseline to Month 20
Title
Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day
Description
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).
Time Frame
Baseline, Month 8, Month 20
Title
Physical Activity - % Time in Sedentary Activity
Description
Measured using ActiGraph physical activity monitors. Outcome was calculated as the percentage of time time spent in sedentary activity compared to wear time.
Time Frame
Baseline, Month 8, Month 20
Title
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables
Description
The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.
Time Frame
Baseline, Month 8, Month 20
Title
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages
Description
The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance/
Time Frame
Baseline, Month 8, Month 20
Title
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of "Red Foods" (Foods High in Sugar and/or Fat)
Description
The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.
Time Frame
Baseline, Month 8, Month 20
Title
Parent Body Mass Index (BMI)
Description
Parent BMI was calculated at three time points.
Time Frame
Baseline, Month 8, Month 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann M Davis, PhD, MPH
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35818033
Citation
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.
Results Reference
derived
PubMed Identifier
30630108
Citation
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.
Results Reference
derived
Learn more about this trial
Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention
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