N/A N=4,329 Randomized Prevention

Children's Healthy Living Community Randomized Trial

Obesity · Acanthosis Nigricans · Central Obesity

Bottom Line

View on ClinicalTrials.gov: NCT01881373 ↗

Enrolled (actual)

4,329

Serious AEs

0.0%

Results posted

May 2020

Primary outcome: Primary: Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex — -2.8; 1.4; -0.40 percentage of 2 to 8 yo children — p=0.02

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CHL program (Other); Delayed Optimized CHL program (Other)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: University of Hawaii
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex	-5.28; 7.32; -0.19	0.003 sig
PRIMARY Change in Waist Circumference	-0.12; 0.59; 0.54	0.02 sig
PRIMARY Prevalence of Acanthosis Nigricans	-4.1; -0.5	<0.01 sig
PRIMARY Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex	-5.28; 7.32; -0.19	0.003 sig
PRIMARY Change in Waist Circumference	-0.12; 0.59; 0.54	0.02 sig
PRIMARY Prevalence of Acanthosis Nigricans	-4.1; -0.5	<0.01 sig
SECONDARY Change in Sugar Sweetened Beverage Intake	-0.05; -0.14	0.44
SECONDARY Change in Mean of Moderate and Vigorous Activity Per Day in Minutes	-1.35; -0.18	0.68
SECONDARY Change in Sedentary and Light Physical Activity	1.78; -1.64	0.55
SECONDARY Change in Screen Time	0.006; 0.10	0.81
SECONDARY Sleep Disturbance Score	1.83; 1.46	0.68
SECONDARY Change in Water Intake	0.02; 0	0.69
SECONDARY Change in Fruit Intake	0.02; -0.19	0.11
SECONDARY Change in Vegetable Intake	0; -0.06	0.40
SECONDARY Change in Metabolic Equivalents (METs) Per Day	-0.29; -0.24	0.71
SECONDARY Change in Hours of Sleep Per Day	0.2; 0; 0.01	0.37
SECONDARY Change in Sugar Sweetened Beverage Intake	-0.05; -0.14	0.44
SECONDARY Change in Screen Time	0.006; 0.10	0.81
SECONDARY Sleep Disturbance Score	1.83; 1.46	0.68
SECONDARY Change in Water Intake	0.02; 0	0.69
SECONDARY Change in Fruit Intake	0.02; -0.19	0.11
SECONDARY Change in Vegetable Intake	0; -0.06	0.40
SECONDARY Change in Hours of Sleep Per Day	0.2; 0; 0.01	0.37

Summary

The goal is to build social/cultural, political/economic, and physical/built environments that will promote active play and intake of healthy food to prevent young child obesity in the Pacific Region. Our methods will support local culture in order to achieve this goal in these remote, underserved native populations. CHL will engage the community, and focus on capacity building and sustainable environmental change. The focus of the CHL community-based program is to promote healthy eating and to increase physical activity. In order to demonstrate effectiveness, the investigators will recruit and measure children in six communities selected in each of our jurisdictions in the Pacific. These represent intervention communities, comparison communities, and temporal communities.

Eligibility Criteria

Inclusion Criteria

Community criteria

Four (4) to six (6) communities in each of five (5) jurisdictions (Alaska, American Samoa, Commonwealth of Northern Mariana Islands, Guam & Hawai'i) chosen for community randomized program based on:

2000 U.S. Census criteria
>1000 people
>25% Native population,
>10% under 5y
CHL Staff Community Evaluation
Sufficient Head Start/preschool, kindergarten
Children live & go to school in area
Separation between communities to allow testing
Access for CHL
Sufficient community cohesiveness
Sufficient settings for program (community centers, parks, stores…)
Child criteria • 2-10 years of age

Exclusion Criteria

Child criteria
Known orthopedic, psychological or neurologic impairments that prevent physical activity
Presence or history of any metabolic or chronic health problems known to affect intermediary metabolism (e.g. untreated thyroid disease, cancer, hepatic disease, renal disease, diabetes, cardiovascular disease, hypertension)
Irregular use of prescription or over-the-counter medications known to affect appetite, food intake or intermediary metabolism (e.g. appetite suppressants, lithium, antidepressants, etc.)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01881373). 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.