Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention
2 other identifiers
interventional
296
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2017
CompletedFirst Posted
Study publicly available on registry
October 6, 2017
CompletedStudy Start
First participant enrolled
October 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2022
CompletedResults Posted
Study results publicly available
September 13, 2023
CompletedSeptember 13, 2023
September 1, 2023
4.1 years
September 28, 2017
March 14, 2023
September 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline to Month 8
Secondary Outcomes (7)
Child Body Mass Index Z-score (BMIz) at Baseline and Month 20
Baseline to Month 20
Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day
Baseline, Month 8, Month 20
Physical Activity - % Time in Sedentary Activity
Baseline, Month 8, Month 20
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables
Baseline, Month 8, Month 20
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages
Baseline, Month 8, Month 20
- +2 more secondary outcomes
Study Arms (2)
iAmHealthy
EXPERIMENTALParticipants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.
Control
ACTIVE COMPARATORParticipants randomized to this group receive comparable content delivered via a newsletter.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Related Publications (3)
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 Dec;44(12):1095-1104. doi: 10.1037/hea0001518. Epub 2025 May 29.
PMID: 40440117DERIVEDForseth 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.
PMID: 35818033DERIVEDDavis 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.
PMID: 30630108DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Megan Olalde
- Organization
- University of Kansas Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Ann M Davis, PhD, MPH
University of Kansas Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2017
First Posted
October 6, 2017
Study Start
October 13, 2017
Primary Completion
November 30, 2021
Study Completion
June 20, 2022
Last Updated
September 13, 2023
Results First Posted
September 13, 2023
Record last verified: 2023-09