Children's Healthy Living Community Randomized Trial

Not Applicable

Completed

Conditions: Obesity
Acanthosis Nigricans
Central Obesity

Interventions: Other: CHL program
Other: Delayed Optimized CHL program

Registration Number: NCT01881373

Lead Sponsor: 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.

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.

Objective. Measure 2-8 year old children at 78 months in the selected communities to determine the long term effect of the CHL program.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 9840

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.)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHL program	CHL program	Multiple component environmentally focused intervention designed with a community engagement process.
Delayed Optimized CHL program	Delayed Optimized CHL program	Comparison community that participated in community engagement process and received delayed optimized program.

Primary Outcome Measures

Name	Time	Method
Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex	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	Baseline, 24 months	Waist circumference measured in centimeters at umbilicus.
Prevalence of Acanthosis Nigricans	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).

Secondary Outcome Measures

Name	Time	Method
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.	cups per day, determined from 2 random days of food records and weighted for weekend and weekday
Change in Sugar Sweetened Beverage Intake	change from baseline to 78 months	cups per day, determined from 2 random days of food records and weighted for weekend and weekday
Change in Vegetable Intake	change from baseline to 78 months	cups per day, determined from 2 random days of food records and weighted for weekend and weekday
Change in Mean of Moderate and Vigorous Activity Per Day in Minutes	Baseline, 24 months	number of minutes per day within bouts of 5 minutes averaged over 4 to 6 days of accelerometer usage
Change in Sedentary and Light Physical Activity	Baseline, 24 months	number of minutes per day within bouts of 5 minutes averaged over 4 to 6 days of accelerometer usage
Change in Hours of Sleep Per Day	change from baseline to 78 months	Sleep hours per day measure by questionnaire as reported by caregiver.
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.	Tayside sleep scale; minimum is 1, maximum is 9, where higher is worse. lower score is less disturbance (range is 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.
Change in Screen Time	change from Baseline to 78 months	Hours per day spent in screen activity
Change in Fruit Intake	change from baseline to 78 months	cups per day, determined from 2 random days of food records and weighted for weekend and weekday
Change in Metabolic Equivalents (METs) Per Day	Baseline, 24 months	number of minutes per day within bouts of 5 minutes averaged over 4 to 6 days of accelerometer usage