Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
9840 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-11-30
Study Completion Date
2020-03-31
Brief Summary
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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.
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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Detailed Description
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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.
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.
Conditions
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Obesity
Acanthosis Nigricans
Central Obesity
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Community randomized intervention for child obesity prevention with multiple levels and components (policy, environment, messaging, and capacity)
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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CHL program
Multiple component environmentally focused intervention designed with a community engagement process.
Group Type
EXPERIMENTAL
CHL program
Intervention Type
OTHER
Multiple component environmentally focused program designed with community engagement.
Delayed Optimized CHL program
Comparison community that participated in community engagement process and received delayed optimized program.
Group Type
OTHER
Delayed Optimized CHL program
Intervention Type
OTHER
CHL programs with fewer component and shorter duration.
Temporal
Communities assessed for temporal trends in anthropometry.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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CHL program
Multiple component environmentally focused program designed with community engagement.
Intervention Type
OTHER
Delayed Optimized CHL program
CHL programs with fewer component and shorter duration.
Intervention Type
OTHER
Eligibility Criteria
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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
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.)
* 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.)
Minimum Eligible Age
2 Years
Maximum Eligible Age
8 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Guam
OTHER
Sponsor Role
collaborator
Northern Marianas College
UNKNOWN
Sponsor Role
collaborator
University of Alaska Fairbanks
OTHER
Sponsor Role
collaborator
American Samoa Community College
UNKNOWN
Sponsor Role
collaborator
University of Hawaii
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Rachel Novotny, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Hawaii
Locations
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University of Hawaii
Honolulu, Hawaii, United States
Site Status
Countries
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United States
References
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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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
DERIVED
Related Links
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http://www.chl-pacific.org
CHL program website
Other Identifiers
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2011-68001-30335
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2018-69001-27551
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
USDA 2011-68001-30335
Identifier Type: -
Identifier Source: org_study_id
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