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Children's Healthy Living Community Randomized Trial (CHL)

Primary Purpose

Obesity, Acanthosis Nigricans, Central Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CHL program

Delayed Optimized CHL program

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Child, Food, Physical Activity, Pacific

Eligibility Criteria

2 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

University of Hawaii

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

No Intervention

Arm Label

CHL program

Delayed Optimized CHL program

Temporal

Arm Description

Multiple component environmentally focused intervention designed with a community engagement process.

Comparison community that participated in community engagement process and received delayed optimized program.

Communities assessed for temporal trends in anthropometry.

Outcomes

Primary Outcome Measures

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.

Change in Waist Circumference

Waist circumference measured in centimeters at umbilicus.

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.

Secondary Outcome Measures

Change in Sugar Sweetened Beverage Intake

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

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

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

Change in Screen Time

Hours per day spent in screen activity

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.

Change in Water Intake

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

Change in Fruit Intake

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

Change in Vegetable Intake

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

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

Change in Hours of Sleep Per Day

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

Full Information

NCT ID

NCT01881373

First Posted

June 17, 2013

Last Updated

April 21, 2020

Sponsor

University of Hawaii

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01881373

Brief Title

Children's Healthy Living Community Randomized Trial

Acronym

CHL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

November 2012 (Actual)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Hawaii

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Acanthosis Nigricans, Central Obesity

Keywords

Obesity, Child, Food, Physical Activity, Pacific

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Community randomized intervention for child obesity prevention with multiple levels and components (policy, environment, messaging, and capacity)

Masking

None (Open Label)

Allocation

Randomized

Enrollment

8371 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CHL program

Arm Type

Experimental

Arm Description

Multiple component environmentally focused intervention designed with a community engagement process.

Arm Title

Delayed Optimized CHL program

Arm Type

Other

Arm Description

Comparison community that participated in community engagement process and received delayed optimized program.

Arm Title

Temporal

Arm Type

No Intervention

Arm Description

Communities assessed for temporal trends in anthropometry.

Intervention Type

Other

Intervention Name(s)

CHL program

Intervention Description

Multiple component environmentally focused program designed with community engagement.

Intervention Type

Other

Intervention Name(s)

Delayed Optimized CHL program

Intervention Description

CHL programs with fewer component and shorter duration.

Primary Outcome Measure Information:

Title

Change in Prevalence of Overweight and Obesity Using Body Mass Index

Description

Time Frame

Baseline, 24 months

Title

Change in Waist Circumference

Description

Waist circumference measured in centimeters at umbilicus.

Time Frame

Baseline, 24 months

Title

Prevalence of Acanthosis Nigricans

Description

Time Frame

Baseline, 24 months

Secondary Outcome Measure Information:

Title

Change in Sugar Sweetened Beverage Intake

Description

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

Time Frame

Baseline, 24 months

Title

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

Description

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

Time Frame

Baseline, 24 months

Title

Change in Sedentary and Light Physical Activity

Description

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

Time Frame

Baseline, 24 months

Title

Change in Screen Time

Description

Hours per day spent in screen activity

Time Frame

2 year change

Title

Sleep Disturbance Score

Description

Time Frame

2 year change

Title

Change in Water Intake

Description

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

Time Frame

Baseline, 24 months

Title

Change in Fruit Intake

Description

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

Time Frame

Baseline, 24 months

Title

Change in Vegetable Intake

Description

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

Time Frame

Baseline, 24 months

Title

Change in Metabolic Equivalents (METs) Per Day

Description

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

Time Frame

Baseline, 24 months

Title

Change in Hours of Sleep Per Day

Description

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

Time Frame

Baseline, 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rachel Novotny, PhD

Organizational Affiliation

University of Hawaii

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Hawaii

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96822

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

http://www.chl-pacific.org

Citations:

PubMed Identifier

24043557

Citation

Fialkowski MK, DeBaryshe B, Bersamin A, Nigg C, Leon Guerrero R, Rojas G, Areta AA, Vargo A, Belyeu-Camacho T, Castro R, Luick B, Novotny R; CHL Team. A community engagement process identifies environmental priorities to prevent early childhood obesity: the Children's Healthy Living (CHL) program for remote underserved populations in the US Affiliated Pacific Islands, Hawaii and Alaska. Matern Child Health J. 2014 Dec;18(10):2261-74. doi: 10.1007/s10995-013-1353-3.

Results Reference

background

PubMed Identifier

24107083

Citation

Wilken LR, Novotny R, Fialkowski MK, Boushey CJ, Nigg C, Paulino Y, Leon Guerrero R, Bersamin A, Vargo D, Kim J, Deenik J. Children's Healthy Living (CHL) Program for remote underserved minority populations in the Pacific region: rationale and design of a community randomized trial to prevent early childhood obesity. BMC Public Health. 2013 Oct 9;13:944. doi: 10.1186/1471-2458-13-944.

Results Reference

background

PubMed Identifier

24251089

Citation

Novotny R, Fialkowski MK, Areta AA, Bersamin A, Braun K, DeBaryshe B, Deenik J, Dunn M, Hollyer J, Kim J, Leon Guerrero RT, Nigg CR, Takahashi R, Wilkens LR. University of Hawai'i Cancer Center Connection: The Pacific Way to Child Wellness: The Children's Healthy Living Program for Remote Underserved Minority Populations of the Pacific Region (CHL). Hawaii J Med Public Health. 2013 Nov;72(11):406-8. No abstract available.

Results Reference

background

PubMed Identifier

25369548

Citation

Braun KL, Nigg CR, Fialkowski MK, Butel J, Hollyer JR, Barber LR, Bersamin A, Coleman P, Teo-Martin U, Vargo AM, Novotny R. Using the ANGELO model to develop the children's healthy living program multilevel intervention to promote obesity preventing behaviors for young children in the U.S.-affiliated Pacific Region. Child Obes. 2014 Dec;10(6):474-81. doi: 10.1089/chi.2014.0102.

Results Reference

background

PubMed Identifier

25393168

Citation

Novotny R, Fialkowski MK, Li F, Paulino Y, Vargo D, Jim R, Coleman P, Bersamin A, Nigg CR, Leon Guerrero RT, Deenik J, Kim JH, Wilkens LR. Systematic Review of Prevalence of Young Child Overweight and Obesity in the United States-Affiliated Pacific Region Compared With the 48 Contiguous States: The Children's Healthy Living Program. Am J Public Health. 2015 Jan;105(1):e22-e35. doi: 10.2105/AJPH.2014.302283.

Results Reference

background

PubMed Identifier

25981090

Citation

Fialkowski MK, Delormier T, Hattori-Uchima M, Leslie JH, Greenberg J, Kim JH, Deenik JL, Dunn MA, Areta IA, Novotny R. Children's Healthy Living Program (CHL) Indigenous Workforce Training to Prevent Childhood Obesity in the Underserved U.S. Affiliated Pacific Region. J Health Care Poor Underserved. 2015 May;26(2 Suppl):83-95. doi: 10.1353/hpu.2015.0054.

Results Reference

background

PubMed Identifier

26622918

Citation

Butel J, Braun KL, Novotny R, Acosta M, Castro R, Fleming T, Powers J, Nigg CR. Assessing intervention fidelity in a multi-level, multi-component, multi-site program: the Children's Healthy Living (CHL) program. Transl Behav Med. 2015 Dec;5(4):460-9. doi: 10.1007/s13142-015-0334-z. Epub 2015 Aug 4.

Results Reference

background

PubMed Identifier

26457888

Citation

Li F, Wilkens LR, Novotny R, Fialkowski MK, Paulino YC, Nelson R, Bersamin A, Martin U, Deenik J, Boushey CJ. Anthropometric measurement standardization in the US-affiliated pacific: Report from the Children's Healthy Living Program. Am J Hum Biol. 2016 May;28(3):364-71. doi: 10.1002/ajhb.22796. Epub 2015 Oct 12.

Results Reference

background

PubMed Identifier

31861756

Citation

Aflague TF, Leon Guerrero RT, Delormier T, Novotny R, Wilkens LR, Boushey CJ. Examining the Influence of Cultural Immersion on Willingness to Try Fruits and Vegetables among Children in Guam: The Traditions Pilot Study. Nutrients. 2019 Dec 20;12(1):18. doi: 10.3390/nu12010018.

Results Reference

background

PubMed Identifier

26771119

Citation

Esquivel M, Nigg CR, Fialkowski MK, Braun KL, Li F, Novotny R. Head Start Wellness Policy Intervention in Hawaii: A Project of the Children's Healthy Living Program. Child Obes. 2016 Feb;12(1):26-32. doi: 10.1089/chi.2015.0071. Epub 2016 Jan 15.

Results Reference

result

PubMed Identifier

30646266

Citation

Novotny R, Davis J, Butel J, Boushey CJ, Fialkowski MK, Nigg CR, Braun KL, Leon Guerrero RT, Coleman P, Bersamin A, Areta AAR, Barber LR Jr, Belyeu-Camacho T, Greenberg J, Fleming T, Dela Cruz-Talbert E, Yamanaka A, Wilkens LR. Effect of the Children's Healthy Living Program on Young Child Overweight, Obesity, and Acanthosis Nigricans in the US-Affiliated Pacific Region: A Randomized Clinical Trial. JAMA Netw Open. 2018 Oct 5;1(6):e183896. doi: 10.1001/jamanetworkopen.2018.3896.

Results Reference

result

PubMed Identifier

31116404

Citation

Butel J, Braun KL, Nigg CR, Leon Guerrero R, Fleming T, Bersamin A, Coleman P, Novotny R. Estimating intervention dose of the multilevel multisite children's healthy living program intervention. Transl Behav Med. 2020 Oct 8;10(4):989-997. doi: 10.1093/tbm/ibz073.

Results Reference

result

PubMed Identifier

30586845

Citation

Gittelsohn J, Novotny R, Trude ACB, Butel J, Mikkelsen BE. Challenges and Lessons Learned from Multi-Level Multi-Component Interventions to Prevent and Reduce Childhood Obesity. Int J Environ Res Public Health. 2018 Dec 24;16(1):30. doi: 10.3390/ijerph16010030.

Results Reference

result

PubMed Identifier

35666503

Citation

Novotny R, Yamanaka AB, Butel J, Boushey CJ, Dela Cruz R, Aflague T, Coleman P, Shallcross L, Fleming T, Wilkens LR. Maintenance Outcomes of the Children's Healthy Living Program on Overweight, Obesity, and Acanthosis Nigricans Among Young Children in the US-Affiliated Pacific Region: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2214802. doi: 10.1001/jamanetworkopen.2022.14802.

Results Reference

derived

PubMed Identifier

28532446

Citation

Novotny R, Li F, Leon Guerrero R, Coleman P, Tufa AJ, Bersamin A, Deenik J, Wilkens LR. Dual burden of malnutrition in US Affiliated Pacific jurisdictions in the Children's Healthy Living Program. BMC Public Health. 2017 May 22;17(1):483. doi: 10.1186/s12889-017-4377-6.

Results Reference

derived

PubMed Identifier

27590179

Citation

Yamanaka A, Fialkowski MK, Wilkens L, Li F, Ettienne R, Fleming T, Power J, Deenik J, Coleman P, Leon Guerrero R, Novotny R. Quality assurance of data collection in the multi-site community randomized trial and prevalence survey of the children's healthy living program. BMC Res Notes. 2016 Sep 2;9(1):432. doi: 10.1186/s13104-016-2212-2.

Results Reference

derived

Links:

URL

http://www.chl-pacific.org

Description

CHL program website

Learn more about this trial

Children's Healthy Living Community Randomized Trial

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