Children's Healthy Living Community Randomized Trial

NCT01881373 | Completed Results

• 3 other identifiers: USDA 2011-68001-303352011-68001-303352018-69001-27551
• Study Type: interventional
• Target: 9,840
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Acanthosis Nigricans; Central Obesity

Keywords

Obesity; Child; Food; Physical Activity; Pacific

Outcome Measures

Primary Outcomes (6)

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

  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

  Waist circumference measured in centimeters at umbilicus.

  Baseline, 78 months

• Prevalence of Acanthosis Nigricans

  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

  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

• Change in Waist Circumference

  Waist circumference measured in centimeters at umbilicus.

  Baseline, 24 months

• Prevalence of Acanthosis Nigricans

  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 Outcomes (17)

• Change in Sugar Sweetened Beverage Intake

  Change from baseline to 24 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 Screen Time

  Change from Baseline to 24 months

• Sleep Disturbance Score

  Change from Baseline to 24 months

Study Arms (3)

CHL program

EXPERIMENTAL

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

Other: CHL program

Delayed Optimized CHL program

OTHER

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

Other: Delayed Optimized CHL program

Temporal

NO INTERVENTION

Communities assessed for temporal trends in anthropometry.

Interventions

CHL program OTHER

Multiple component environmentally focused program designed with community engagement.

CHL program

Delayed Optimized CHL program OTHER

CHL programs with fewer component and shorter duration.

Delayed Optimized CHL program

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Hawaii: lead
• University of Guam: collaborator
• Northern Marianas College: collaborator
• University of Alaska Fairbanks: collaborator
• American Samoa Community College: collaborator

Study Sites (1)

University of Hawaii

Honolulu, Hawaii, 96822, United States

Location

Related Publications (28)

• 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.

  PMID: 24043557 BACKGROUND

• 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.

  PMID: 24107083 BACKGROUND

• 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.

  PMID: 24251089 BACKGROUND

• 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.

  PMID: 25369548 BACKGROUND

• 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.

  PMID: 25393168 BACKGROUND

• 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.

  PMID: 25981090 BACKGROUND

• 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.

  PMID: 26622918 BACKGROUND

• 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.

  PMID: 26457888 BACKGROUND

• 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.

  PMID: 31861756 BACKGROUND

• Yamanaka AB, Davis JD, Wilkens LR, Hurwitz EL, Fialkowski MK, Deenik J, Leon Guerrero RT, Novotny R. Determination of Child Waist Circumference Cut Points for Metabolic Risk Based on Acanthosis Nigricans, the Children's Healthy Living Program. Prev Chronic Dis. 2021 Jun 24;18:E64. doi: 10.5888/pcd18.210021.

  PMID: 34166179 BACKGROUND

• Butel J, Braun KL. The Role of Collective Efficacy in Reducing Health Disparities: A Systematic Review. Fam Community Health. 2019 Jan/Mar;42(1):8-19. doi: 10.1097/FCH.0000000000000206.

  PMID: 30431465 BACKGROUND

• Leon Guerrero RT, Barber LR, Aflague TF, Paulino YC, Hattori-Uchima MP, Acosta M, Wilkens LR, Novotny R. Prevalence and Predictors of Overweight and Obesity among Young Children in the Children's Healthy Living Study on Guam. Nutrients. 2020 Aug 20;12(9):2527. doi: 10.3390/nu12092527.

  PMID: 32825433 BACKGROUND

• Novotny R, Earle ME, Jung YO, Julian GJ, Hill E, Leon Guerrero RT, Coleman P, Deenik J, Boushey C, Wilkens LR. University of Hawai'i Cancer Center Connection: Pacific Tracker (PacTrac) Version 3.1 Diet and Physical Activity Assessment Tool for the Pacific Region. Hawaii J Health Soc Welf. 2021 Jul;80(7):165-168.

  PMID: 34278324 BACKGROUND

• Greenberg JA, Luick B, Alfred JM, Barber LR Jr, Bersamin A, Coleman P, Esquivel M, Fleming T, Leon Guerrero RT, Hollyer J, Johnson EL, Novotny R, deBlair Remengesau S, Yamanaka A. The Affordability of a Thrifty Food Plan-based Market Basket in the United States-affiliated Pacific Region. Hawaii J Health Soc Welf. 2020 Jul 1;79(7):217-223.

  PMID: 32666055 BACKGROUND

• Yonemori KM, Ennis T, Novotny R, Fialkowski MK, Ettienne R, Wilkens LR, Leon Guerrero RT, Bersamin A, Coleman P, Li F, Boushey CJ. Collecting wrappers, labels, and packages to enhance accuracy of food records among children 2-8 years in the Pacific region: Children's Healthy Living Program (CHL). J Food Compost Anal. 2017 Dec;64(Pt 1):112-118. doi: 10.1016/j.jfca.2017.04.012. Epub 2017 Apr 23.

  PMID: 29398780 BACKGROUND

• Paulino YC, Ettienne R, Novotny R, Wilkens LR, Shomour M, Sigrah C, Remengesau SD, Johnson EL, Alfred JM, Gilmatam DF. Areca (betel) nut chewing practices of adults and health behaviors of their children in the Freely Associated States, Micronesia: Findings from the Children's Healthy Living (CHL) Program. Cancer Epidemiol. 2017 Oct;50(Pt B):234-240. doi: 10.1016/j.canep.2017.07.009.

  PMID: 29120830 BACKGROUND

• 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.

  PMID: 28532446 BACKGROUND

• 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.

  PMID: 27590179 BACKGROUND

• Novotny R, Li F, Fialkowski MK, Bersamin A, Tufa A, Deenik J, Coleman P, Guerrero RL, Wilkens LR; Children's Healthy Living (CHL) Program. Prevalence of obesity and acanthosis nigricans among young children in the children's healthy living program in the United States Affiliated Pacific. Medicine (Baltimore). 2016 Sep;95(37):e4711. doi: 10.1097/MD.0000000000004711.

  PMID: 27631218 BACKGROUND

• Fialkowski MK, Yamanaka A, Wilkens LR, Braun KL, Butel J, Ettienne R, McGlone K, Remengesau S, Power JM, Johnson E, Gilmatam D, Fleming T, Acosta M, Belyeu-Camacho T, Shomour M, Sigrah C, Nigg C, Novotny R. Recruitment Strategies and Lessons Learned from the Children's Healthy Living Program Prevalence Survey. AIMS Public Health. 2016 Mar 21;3(1):140-157. doi: 10.3934/publichealth.2016.1.140. eCollection 2016.

  PMID: 29546153 BACKGROUND

• Esquivel MK, Nigg CR, Fialkowski MK, Braun KL, Li F, Novotny R. Influence of Teachers' Personal Health Behaviors on Operationalizing Obesity Prevention Policy in Head Start Preschools: A Project of the Children's Healthy Living Program (CHL). J Nutr Educ Behav. 2016 May;48(5):318-325.e1. doi: 10.1016/j.jneb.2016.02.007.

  PMID: 27169640 BACKGROUND

• 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.

  PMID: 26771119 BACKGROUND

• 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.

  PMID: 30646266 RESULT

• 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.

  PMID: 31116404 RESULT

• 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.

  PMID: 30586845 RESULT

• Korn AR, Butel J, Davis J, Yamanaka AB, Coleman P, Wilkens LR, Economos CD, Novotny R. Role of social ecological model level on young Pacific children's sugar-sweetened beverage and water intakes: Children's Healthy Living intervention. Public Health Nutr. 2021 Jun;24(8):2318-2323. doi: 10.1017/S1368980020004796. Epub 2020 Nov 25.

  PMID: 33234187 RESULT

• Dumuid D, Yamanaka AB, Chong KH, Okely AD, Wilkens LR, Shvetsov YB, Lozano CP, Novotny R. Diet, Activity and Sleep Clusters Associated With Obesity Markers of Children in the US-Affiliated Pacific. Acta Paediatr. 2025 Jul;114(7):1642-1652. doi: 10.1111/apa.70012. Epub 2025 Feb 24.

  PMID: 39989394 DERIVED

• 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.

  PMID: 35666503 DERIVED

Related Links

• CHL program website

MeSH Terms

Conditions

Obesity; Acanthosis Nigricans; Obesity, Abdominal; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Results Point of Contact

• Title: Rachel Novotny
• Organization: University of Hawaii

novotny@hawaii.edu

808-956-3848

Study Officials

• Rachel Novotny, PhD

  University of Hawaii

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 19, 2013
• Study Start: November 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: March 1, 2020
• Last Updated: March 4, 2024
• Results First Posted: May 1, 2020

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2017 to current
• Access Criteria: citi training, approval of proposal by CHL program steering committee

Locations

US (1)