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Children's Healthy Living Program (CHL)

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ClinicalTrials.gov Identifier: NCT01881373
Recruitment Status : Unknown
Verified June 2013 by University of Hawaii.
Recruitment status was:  Recruiting
First Posted : June 19, 2013
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
University of Hawaii

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.


Condition or disease Intervention/treatment Phase
Obesity Other: CHL program Phase 4

Detailed Description:

The specific objectives of our study are as follows.

Objective. Decrease the prevalence of young child overweight and obesity by 5%; and its functional outcomes (decrease acanthosis nigricans by 5%, and increase sleep by 15 min/day); increase moderate to vigorous physical activity by 10 min/day and decrease sedentary behavior (screen time) by 10 min/day; increase healthy eating (fruit and vegetable intake by 1 serving/day, water intake by ½ cup/day; decrease sweetened beverage intake by ½ cup/day, through community-based primary prevention environmental interventions in PLGA regions.

Objective. Measure 2-8-year-old children at baseline, 12 months and 24 months in selected communities to track behaviors and anthropometry that indicate healthy eating, physical activity, and BMI.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Children's Healthy Living Program for Remote Underserved Minority Populations in the Pacific Region
Study Start Date : April 2011
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: CHL program
Multiple component environmentally focused intervention designed with a community engagement process.
Other: CHL program
Multiple component environmentally focused program designed with community engagement.

No Intervention: Comparison community
Comparison community that participated in community engagement process and will receive delayed optimized program.



Primary Outcome Measures :
  1. Change in prevalence of overweight and obesity using body mass index [ Time Frame: Baseline, 12 months, 24 months ]
    Standardized staff using standard equipment to measure weight and height. Body mass index is weight in kg divided by height in meters squared.

  2. Change in waist circumference [ Time Frame: Baseline, 12 months, 24 months ]
    Standardized staff using standard tape measures measuring waist at the umbilicus.


Secondary Outcome Measures :
  1. Change in key dietary intakes [ Time Frame: Baseline, 24 months ]
    Sugar sweetened beverages (in units of cups), fruits and vegetables (in units of cups), water (units in cups) as measured by two days of food records.

  2. Change in physical activity and sedentary behavior [ Time Frame: Baseline, 24 months ]
    Minutes of moderate and vigorous activity per day and minutes of sedentary activity as measured by 2 days of physical activity logs

  3. Change in level of physical activity [ Time Frame: Baseline, 24 months ]
    Counts of activity level based on accelerometers worn on the wrist.



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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Community criteria

Four (4) 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…)
  • Two other communities in each jurisdiction were selected for temporal assessment of an abbreviated set of measures
  • Child criteria • 2-8 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881373


Locations
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United States, Hawaii
University of Hawaii Recruiting
Honolulu, Hawaii, United States, 96822
Contact: Rachel Novotny, PhD    808-956-3848    novotny@hawaii.edu   
Contact: Lynne R Wilkens, DrPH    808-564-5848    wilkens@hawaii.edu   
Principal Investigator: Rachel Novotny, PhD         
Sponsors and Collaborators
University of Hawaii
Investigators
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Principal Investigator: Rachel Novotny, PhD University of Hawaii

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT01881373     History of Changes
Other Study ID Numbers: USDA 2011-68001-30335
CRIS no. 0224871 ( Other Grant/Funding Number: USDA )
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013
Keywords provided by University of Hawaii:
Obesity
Child
Food
Physical Activity
Pacific
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms