Children's Healthy Living Community Randomized Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Children's Healthy Living Program for Remote Underserved Minority Populations in the Pacific Region

Conditions
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Obesity, Acanthosis Nigricans, Central Obesity

Intervention / Treatment
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* Other: CHL program
* Other: Delayed Optimized CHL program


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Community randomized intervention for child obesity prevention with multiple levels and components (policy, environment, messaging, and capacity)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHL program<br>Multiple component environmentally focused intervention designed with a community engagement process. | Other: CHL program<br>* Multiple component environmentally focused program designed with community engagement.<br>|
| Other: Delayed Optimized CHL program<br>Comparison community that participated in community engagement process and received delayed optimized program. | Other: Delayed Optimized CHL program<br>* CHL programs with fewer component and shorter duration.<br>|
| No Intervention: Temporal<br>Communities assessed for temporal trends in anthropometry. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Prevalence of Overweight and Obesity Using Body Mass Index | Body mass index is weight in kg divided by height in meters squared. Overweight is > = 85th percentile to < 95th percentile BMI for age and sex according to CDC 2000. Obesity is > = 95th percentile BMI for age and sex according to CDC 2000. Change from baseline to 24 months in prevalence of overweight plus obesity in selected communities. | Baseline, 24 months | 
| Change in Waist Circumference | Waist circumference measured in centimeters at umbilicus. | Baseline, 24 months | 
| Prevalence of Acanthosis Nigricans | Screening on back of neck for Acanthosis nigricans according to Burke, J., D. Hale, H. Hazuda, and M. Stern. 1999. A quantitative scale of acanthosis nigricans. Diabetes Care. 22(10):1655-1659. Epub 1999/10/20. PubMed PMID: 10526730. | Baseline, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sugar Sweetened Beverage Intake | cups per day, determined from 2 random days of food records and weighted for weekend and weekday | Baseline, 24 months | 
| Change in Mean of Moderate and Vigorous Activity Per Day in Minutes | number of minutes per day within bouts of 5 minutes averaged over 4 to 6 days of accelerometer usage | Baseline, 24 months | 
| Change in Sedentary and Light Physical Activity | number of minutes per day within bouts of 5 minutes averaged over 4 to 6 days of accelerometer usage | Baseline, 24 months | 
| Change in Screen Time | Hours per day spent in screen activity | 2 year change | 
| Sleep Disturbance Score | lower score is less disturbance (1-9) Tayside Children's Sleep Questionnaire by McGreavey JA, Donnan PT, Pagliari HC, Sullivan FM.The Tayside children's sleep questionnaire: a simple tool to evaluate sleep problems in young children. Child Care Health Dev. 2005 Sep;31(5):539-44. | 2 year change | 
| Change in Water Intake | cups per day, determined from 2 random days of food records and weighted for weekend and weekday | Baseline, 24 months | 
| Change in Fruit Intake | cups per day, determined from 2 random days of food records and weighted for weekend and weekday | Baseline, 24 months | 
| Change in Vegetable Intake | cups per day, determined from 2 random days of food records and weighted for weekend and weekday | Baseline, 24 months | 
| Change in Metabolic Equivalents (METs) Per Day | number of minutes per day within bouts of 5 minutes averaged over 4 to 6 days of accelerometer usage | Baseline, 24 months | 
| Change in Hours of Sleep Per Day | Sleep hours per day measure by questionnaire as reported by caregiver. | Baseline, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Child, Food, Physical Activity, Pacific