Brief Title
Children's Healthy Living Community Randomized Trial
Official Title
Children's Healthy Living Program for Remote Underserved Minority Populations in the Pacific Region
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. 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.
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 sleep ; increase moderate to vigorous physical activity and decrease sedentary behavior (screen time); increase healthy eating (fruit and vegetable intake, water intake; decrease sweetened beverage intake, through community-based primary prevention environmental interventions in the Pacific region. Objective. Measure 2-8-year-old children at baseline and 24 months in selected communities to track behaviors and anthropometry that indicate healthy eating, physical activity, and BMI.
Study Type
Interventional
Primary Outcome
Change in Prevalence of Overweight and Obesity Using Body Mass Index
Secondary Outcome
Change in Sugar Sweetened Beverage Intake
Condition
Obesity
Intervention
CHL program
Study Arms / Comparison Groups
CHL program
Description: Multiple component environmentally focused intervention designed with a community engagement process.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
8371
Start Date
November 2012
Completion Date
August 2015
Primary Completion Date
August 2015
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.)
Gender
All
Ages
2 Years - 8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Rachel Novotny, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01881373
Organization ID
USDA 2011-68001-30335
Secondary IDs
2011-68001-30335
Responsible Party
Sponsor
Study Sponsor
University of Hawaii
Collaborators
University of Guam
Study Sponsor
Rachel Novotny, PhD, Principal Investigator, University of Hawaii
Verification Date
April 2020