Children's Healthy Living Community Randomized Trial (CHL)

June 19, 2023 updated by: University of Hawaii

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9840

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96822
        • University of Hawaii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Delayed Optimized CHL program
Comparison community that participated in community engagement process and received delayed optimized program.
Other: Delayed Optimized CHL program
CHL programs with fewer component and shorter duration.
No Intervention: Temporal
Communities assessed for temporal trends in anthropometry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Waist Circumference
Time Frame: Baseline, 24 months
Waist circumference measured in centimeters at umbilicus.
Baseline, 24 months
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.
Baseline, 24 months
Change in Waist Circumference
Time Frame: Baseline, 78 months
Waist circumference measured in centimeters at umbilicus.
Baseline, 78 months
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).
Baseline, 24 months
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.
Baseline, 78 months
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).
Baseline, 78 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 24 months
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
Baseline, 24 months
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
Baseline, 24 months
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
Change from baseline to 24 months
Change in Screen Time
Time Frame: Change from Baseline to 24 months
Hours per day spent in screen activity
Change from Baseline to 24 months
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.
Change from Baseline to 24 months
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.
Change from Baseline to 24 months
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
Change from baseline to 24 months
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
Change from baseline to 24 months
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.
change from baseline to 24 months
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
change from baseline to 78 months
Change in Screen Time
Time Frame: change from Baseline to 78 months
Hours per day spent in screen activity
change from Baseline to 78 months
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.
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 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
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 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
change from baseline to 78 months
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
change from baseline to 78 months
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.
change from baseline to 78 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hawaii

Collaborators

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

Investigators

  • Principal Investigator: Rachel Novotny, PhD, University of Hawaii

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 18, 2013

First Posted (Estimated)

June 19, 2013

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USDA 2011-68001-30335
  • 2011-68001-30335 (Other Grant/Funding Number: USDA/NIFA/AFRI)
  • 2018-69001-27551 (Other Grant/Funding Number: USDA/NIFA/AFRI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Request system whereby researchers submit a proposal, if approved by CHL steering committee, data is released using secure systems

IPD Sharing Time Frame

2017 to current

IPD Sharing Access Criteria

citi training, approval of proposal by CHL program steering committee

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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