Children’s Healthy Living Community Randomized Trial

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 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

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