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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- Change in waist circumference [ Time Frame: Baseline, 12 months, 24 months ]Standardized staff using standard tape measures measuring waist at the umbilicus.
- 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.
- 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
- Change in level of physical activity [ Time Frame: Baseline, 24 months ]Counts of activity level based on accelerometers worn on the wrist.
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
|United States, Hawaii|
|University of Hawaii||Recruiting|
|Honolulu, Hawaii, United States, 96822|
|Contact: Rachel Novotny, PhD 808-956-3848 firstname.lastname@example.org|
|Contact: Lynne R Wilkens, DrPH 808-564-5848 email@example.com|
|Principal Investigator: Rachel Novotny, PhD|
|Principal Investigator:||Rachel Novotny, PhD||University of Hawaii|