Status:
COMPLETED
Children's Healthy Living Community Randomized Trial
Lead Sponsor:
University of Hawaii
Collaborating Sponsors:
University of Guam
Northern Marianas College
Conditions:
Obesity
Acanthosis Nigricans
Eligibility:
All Genders
2-8 years
Phase:
NA
Brief 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....
Detailed Description
The specific objectives of our study are as follows. Objective. Decrease the prevalence of young child overweight and obesity; and its functional outcomes (decrease acanthosis nigricans, and increase...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
9840 Patients enrolled
Trial Details
Trial ID
NCT01881373
Start Date
November 1 2012
End Date
March 1 2020
Last Update
March 4 2024
Active Locations (1)
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1
University of Hawaii
Honolulu, Hawaii, United States, 96822