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Completed

NCT Number: NCT01881373

Children's Healthy Living Community Randomized Trial

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.

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Key information

Conditions

Obesity Acanthosis Nigricans Behavior Body Weight Central Obesity Hyperpigmentation Melanosis Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pigmentation Disorders Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hawaii

Honolulu, Hawaii, 96822, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

CHL program

Other

Multiple component environmentally focused program designed with community engagement.

Delayed Optimized CHL program

Other

CHL programs with fewer component and shorter duration.

Primary outcomes

  1. Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex

    Time frame: Baseline, 24 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 24 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.

  2. Change in Waist Circumference

    Time frame: Baseline, 78 months

    Waist circumference measured in centimeters at umbilicus.

  3. Prevalence of Acanthosis Nigricans

    Time frame: Baseline, 24 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).

  4. Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex

    Time frame: 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.

  5. Change in Waist Circumference

    Time frame: Baseline, 24 months

    Waist circumference measured in centimeters at umbilicus.

  6. Prevalence of Acanthosis Nigricans

    Time frame: 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 outcomes

  1. Change in Sugar Sweetened Beverage Intake

    Time frame: Change from baseline to 24 months

    cups per day, determined from 2 random days of food records and weighted for weekend and weekday

  2. Change in Mean of Moderate and Vigorous Activity Per Day in Minutes

    Time frame: Baseline, 24 months

    number of minutes per day within bouts of 5 minutes averaged over 4 to 6 days of accelerometer usage

  3. Change in Sedentary and Light Physical Activity

    Time frame: Baseline, 24 months

    number of minutes per day within bouts of 5 minutes averaged over 4 to 6 days of accelerometer usage

  4. Change in Screen Time

    Time frame: Change from Baseline to 24 months

    Hours per day spent in screen activity

  5. Sleep Disturbance Score

    Time frame: Change from Baseline to 24 months

    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.

  6. Change in Water Intake

    Time frame: Change from Baseline to 24 months

    cups per day, determined from 2 random days of food records and weighted for weekend and weekday. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.

  7. Change in Fruit Intake

    Time frame: Change from baseline to 24 months

    cups per day, determined from 2 random days of food records and weighted for weekend and weekday

  8. Change in Vegetable Intake

    Time frame: Change from baseline to 24 months

    cups per day, determined from 2 random days of food records and weighted for weekend and weekday

  9. Change in Metabolic Equivalents (METs) Per Day

    Time frame: Baseline, 24 months

    number of minutes per day within bouts of 5 minutes averaged over 4 to 6 days of accelerometer usage

  10. Change in Hours of Sleep Per Day

    Time frame: change from baseline to 24 months

    Sleep hours per day measure by questionnaire as reported by caregiver.

  11. Change in Sugar Sweetened Beverage Intake

    Time frame: change from baseline to 78 months

    cups per day, determined from 2 random days of food records and weighted for weekend and weekday

  12. Change in Screen Time

    Time frame: change from Baseline to 78 months

    Hours per day spent in screen activity

  13. Sleep Disturbance Score

    Time frame: 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.

  14. Change in Water Intake

    Time frame: 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

  15. Change in Fruit Intake

    Time frame: change from baseline to 78 months

    cups per day, determined from 2 random days of food records and weighted for weekend and weekday

  16. Change in Vegetable Intake

    Time frame: change from baseline to 78 months

    cups per day, determined from 2 random days of food records and weighted for weekend and weekday

  17. Change in Hours of Sleep Per Day

    Time frame: change from baseline to 78 months

    Sleep hours per day measure by questionnaire as reported by caregiver.

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

  • American Samoa Community College
  • Northern Marianas College
  • University of Alaska Fairbanks
  • University of Guam

Registry information

Official study title

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

Acronym: CHL

Important dates

Study start
2012
Primary completion
2015
Study completion
2020
First posted
Jun 19, 2013
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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