N/A
N=296
Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention
Weight Loss
Bottom Line
View on ClinicalTrials.gov: NCT03304249 ↗Enrolled (actual)
296
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Child Body Mass Index Z-score (BMIz) at Baseline and Month 8 — 1.78; 1.92; 1.78; 1.96 Z-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- iAmHealthy Healthy Lifestyles Program (Behavioral); Newsletter (Other)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Child Body Mass Index Z-score (BMIz) at Baseline and Month 8 |
1.78; 1.92; 1.78; 1.96 | — |
| SECONDARY Child Body Mass Index Z-score (BMIz) at Baseline and Month 20 |
1.78; 1.92; 1.82; 2.04 | — |
| SECONDARY Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day |
51.14; 52.95; 47.16; 49.07; 44.86; 41.37 | — |
| SECONDARY Physical Activity - % Time in Sedentary Activity |
59.14; 56.57; 61.14; 59.62; 63.89; 63.28 | — |
| SECONDARY Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables |
3.27; 2.68; 3.04; 2.45; 2.89; 2.58 | — |
| SECONDARY Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages |
1.19; 1.14; 0.75; 1.08; 0.93; 1.21 | — |
| SECONDARY Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of "Red Foods" (Foods High in Sugar and/or Fat) |
6.64; 7.40; 5.12; 6.28; 5.69; 6.89 | — |
| SECONDARY Parent Body Mass Index (BMI) |
35.83; 33.69; 35.94; 33.79; 35.23; 34.31 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03304249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.