Children's Healthy Living Program for Remote Underserved Minority Populations in the Pacific Region
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9,840
- 试验地点
- 2
- 主要终点
- Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex
研究概览
简要总结
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.
详细描述
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.
Objective. Measure 2-8 year old children at 78 months in the selected communities to determine the long term effect of the CHL program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.)
研究组 & 干预措施
CHL program
Multiple component environmentally focused intervention designed with a community engagement process.
干预措施: CHL program (Other)
Delayed Optimized CHL program
Comparison community that participated in community engagement process and received delayed optimized program.
干预措施: Delayed Optimized CHL program (Other)
Temporal
Communities assessed for temporal trends in anthropometry.
结局指标
主要结局
Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex
时间窗: Baseline, 78 months
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 78 months in prevalence of overweight plus obesity in selected communities. Comparison group is healthy weight \>= 5th percentile to \< 85th percentile for age and sex according to CDC 2000. Underweight (\<5th percentile) were excluded.
Change in Waist Circumference
时间窗: Baseline, 24 months
Waist circumference measured in centimeters at umbilicus.
Prevalence of Acanthosis Nigricans
时间窗: Baseline, 78 months
Scale title: Burke Acanthosis nigricans Score, minimum 0, maximum 4. Higher score is worse. Analysis was dichotomized as present (1-4) or absent (0). A 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. Scale varies from 0 to 4 with 0 as not present and 4 most severe. Analysis was done on absent (0) or present (1-4).
次要结局
- Change in Water Intake(change from baseline to 78 months.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.)
- Change in Sugar Sweetened Beverage Intake(change from baseline to 78 months)
- Change in Vegetable Intake(change from baseline to 78 months)
- Change in Mean of Moderate and Vigorous Activity Per Day in Minutes(Baseline, 24 months)
- Change in Sedentary and Light Physical Activity(Baseline, 24 months)
- Change in Hours of Sleep Per Day(change from baseline to 78 months)
- Sleep Disturbance Score(Change from baseline to 78 months, The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.)
- Change in Screen Time(change from Baseline to 78 months)
- Change in Fruit Intake(change from baseline to 78 months)
- Change in Metabolic Equivalents (METs) Per Day(Baseline, 24 months)