Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-68001-30335 | Other Grant/Funding Number | USDA/NIFA/AFRI | |
| 2018-69001-27551 | Other Grant/Funding Number | USDA/NIFA/AFRI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Guam | OTHER |
| Northern Marianas College | UNKNOWN |
| University of Alaska Fairbanks | OTHER |
| American Samoa Community College |
Not provided
Not provided
Not provided
Not provided
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 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.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHL program | Experimental | Multiple component environmentally focused intervention designed with a community engagement process. |
|
| Delayed Optimized CHL program | Other | Comparison community that participated in community engagement process and received delayed optimized program. |
|
| Temporal | No Intervention | Communities assessed for temporal trends in anthropometry. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHL program | Other | Multiple component environmentally focused program designed with community engagement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sugar Sweetened Beverage Intake | 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 Mean of Moderate and Vigorous Activity Per Day in Minutes |
Not provided
Inclusion 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
CHL Staff Community Evaluation
Child criteria • 2-10 years of age
Exclusion Criteria:
Child criteria
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Novotny, PhD | University of Hawaii | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hawaii | Honolulu | Hawaii | 96822 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24043557 | Background | 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. | |
| 24107083 |
| Label | URL |
|---|---|
| CHL program website | View source |
Not provided
Request system whereby researchers submit a proposal, if approved by CHL steering committee, data is released using secure systems
2017 to current
citi training, approval of proposal by CHL program steering committee
Eighteen selected communities were matched for size and randomized within jurisdiction to intervention or control. Nine additional communities were monitored with no randomization for temporal trends of obesity. 2-8 year old children and their households and environments were measured and evaluated in each of these communities.
communities were selected where >25% of the population was of indigenous/native descent (native to each jurisdiction), >10% of the population was under age 10 years, >1000 population size, and communities were relatively accessible
| ID | Title | Description |
|---|---|---|
| FG000 | CHL Program | Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement. |
| FG001 | Delayed Optimized CHL Program | Comparison community that participated in community engagement process and received delayed optimized program. |
| FG002 | Temporal | Communities assessed for temporal trends |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| 24 Months |
| |||||||||||||
| 78 Months |
|
2 to 8 year old children
| ID | Title | Description |
|---|---|---|
| BG000 | CHL Program | Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement. |
| BG001 | Control Community |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Children 2-8y in selected communities of the Pacific Region; the children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Posted | Mean | Standard Error | percentage of 2 to 8 yo children | Baseline, 24 months | communities | communities |
|
The children representing the communities were observed for the assessment periods only.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CHL Program | Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Novotny | University of Hawaii | 808-956-3848 | novotny@hawaii.edu |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D000052 | Acanthosis Nigricans |
| D056128 | Obesity, Abdominal |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| UNKNOWN |
Community randomized intervention for child obesity prevention with multiple levels and components (policy, environment, messaging, and capacity)
Not provided
Not provided
Not provided
Not provided
| Delayed Optimized CHL program | Other | CHL programs with fewer component and shorter duration. |
|
| 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 |
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 | number of minutes per day within bouts of 5 minutes averaged over 4 to 6 days of accelerometer usage | Baseline, 24 months |
| Change in Screen Time | Hours per day spent in screen activity | Change from Baseline to 24 months |
| Sleep Disturbance Score | 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 | 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 | 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 | 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 Metabolic Equivalents (METs) Per Day | number of minutes per day within bouts of 5 minutes averaged over 4 to 6 days of accelerometer usage | Baseline, 24 months |
| Change in Hours of Sleep Per Day | Sleep hours per day measure by questionnaire as reported by caregiver. | change from baseline to 24 months |
| Change in Sugar Sweetened Beverage Intake | 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 | Hours per day spent in screen activity | change from Baseline to 78 months |
| Sleep Disturbance Score | 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 | 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 | 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 | 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 | Sleep hours per day measure by questionnaire as reported by caregiver. | change from baseline to 78 months |
| 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. |
| 24251089 | 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. |
| 25369548 | 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. |
| 25393168 | 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. |
| 25981090 | 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. |
| 26622918 | 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. |
| 26457888 | 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. |
| 31861756 | 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. |
| 34166179 | 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. |
| 30431465 | 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. |
| 32825433 | 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. |
| 34278324 | 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. |
| 32666055 | 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. |
| 29398780 | 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. |
| 29120830 | 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. |
| 28532446 | 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. |
| 27590179 | 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. |
| 27631218 | 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. |
| 29546153 | 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. |
| 27169640 | 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. |
| 26771119 | 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. |
| 30646266 | Result | 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. |
| 31116404 | 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. |
| 30586845 | 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. |
| 33234187 | 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. |
| 41796940 | Derived | Wilkens LR, Dela Cruz R, Yamanaka AB, Hammond K, Shvetsov YB, Aflague T, Butel J, Coleman P, Fleming T, Shallcross L, Fialkowski MK, Young C, Ing C, Franck K, Esquivel M, Novotny R. Framework for Identifying Signature Foods for Health in the Children's Healthy Living Program in the United States Affiliated Pacific Region. J Nutr. 2026 May;156(5):101466. doi: 10.1016/j.tjnut.2026.101466. Epub 2026 Mar 6. |
| 39989394 | Derived | 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. |
| 35666503 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Control community that participated in community engagement process and received delayed optimized program. |
| BG002 | Temporal | Control community with limited interaction; for temporal change assessment of anthropometry. |
| BG003 | Total | Total of all reporting groups |
| community |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Participants were from communities in 5 jurisdictions which were Commonwealth of the Northern Mariana Islands, Guam, American Samoa, Alaska and Hawaii. In this table, the United States represents Alaska and United States Minor Outlying Islands represents Hawaii. | Count of Participants | Participants | Participants |
|
Multiple component environmentally focused intervention designed with a community engagement process.
CHL program: Multiple component environmentally focused program designed with community engagement.
| OG001 | Control Community | Comparison community that participated in community engagement process and will receive delayed optimized program. |
| OG002 | Temporal | Communities measured for temporal trends |
|
|
|
| Primary | Change in Waist Circumference | Waist circumference measured in centimeters at umbilicus. | Children 2-8 years in the selected Pacific communities.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Posted | Mean | Standard Error | centimeters | Baseline, 78 months | communities | communities |
|
|
|
|
| Primary | 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). | Children 2-8 in communities that were randomized to intervention or control. Acanthosis nigricans not assessed in temporal communities.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Posted | Mean | Standard Error | percentage of 2-8 yo children | Baseline, 24 months | communities | communities |
|
|
|
|
| Primary | 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. | Children 2-8y in selected communities of the Pacific Region; the children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Posted | Mean | Standard Error | percentage of 2 to 8 yo children | Baseline, 78 months | communities | communities |
|
|
|
|
| Primary | Change in Waist Circumference | Waist circumference measured in centimeters at umbilicus. | Children 2-8 years in the selected Pacific communities. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Posted | Mean | 95% Confidence Interval | centimeters | Baseline, 24 months | communities | communities |
|
|
|
|
| Secondary | Change in Sugar Sweetened Beverage Intake | cups per day, determined from 2 random days of food records and weighted for weekend and weekday | Children 2 to 8 from communities randomized to CHL program or Control. Temporal communities not assessed for sugar sweetened beverage intake.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Posted | Mean | Standard Error | cups per day | Change from baseline to 24 months | communities | communities |
|
|
|
|
| Secondary | 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 | Children 2 to 8 randomized to CHL program or Control Community. Temporal community not assessed for physical activity. | Posted | Mean | Standard Error | number of minutes per day within bouts o | Baseline, 24 months | communities | communities |
|
|
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| Secondary | 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 | Children 2 to 8 randomized to CHL program or Control Community. Temporal community not assessed for physical activity. | Posted | Mean | Standard Error | number of minutes per day within bouts o | Baseline, 24 months | communities | communities |
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| Secondary | Change in Screen Time | Hours per day spent in screen activity | Children 2 to 8 randomized to CHL program or Control Community. Temporal community not assessed for screen time.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Posted | Mean | Standard Error | hours per day | Change from Baseline to 24 months | communities | communities |
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| Secondary | Sleep Disturbance Score | 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. | Children 2 to 8y randomized to CHL program or Control Community. Temporal community not assessed for sleep disturbance.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Posted | Mean | Standard Error | units on a scale | Change from Baseline to 24 months | communities | communities |
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| Secondary | Change in Water Intake | 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. | Children 2 to 8 randomized to CHL program or Control Community. Temporal community not assessed for water intake. | Posted | Mean | Standard Error | cups per day | Change from Baseline to 24 months | communities | communities |
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| Secondary | Change in Fruit Intake | cups per day, determined from 2 random days of food records and weighted for weekend and weekday | Children 2 to 8 randomized to CHL program or Control Community. Temporal community not assessed for fruit intake. | Posted | Mean | Standard Error | cups per day | Change from baseline to 24 months | communities | communities |
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| Secondary | Change in Vegetable Intake | cups per day, determined from 2 random days of food records and weighted for weekend and weekday | Children 2 to 8y randomized to CHL program or Control Community. Temporal community not assessed for vegetable intake. | Posted | Mean | Standard Error | cups per day | Change from baseline to 24 months | communities | communities |
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| Secondary | 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 | Children 2 to 8y randomized to CHL program or Control Community. Temporal community not assessed for accelerometry. | Posted | Mean | Standard Error | number of minutes per day within bouts o | Baseline, 24 months | communities | communities |
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| Secondary | Change in Hours of Sleep Per Day | Sleep hours per day measure by questionnaire as reported by caregiver. | Children 2-8y in the selected Pacific communities. | Posted | Mean | Standard Error | hours per day | change from baseline to 24 months | communities | communities |
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| Primary | 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). | Children 2-8 in communities that were randomized to intervention or control. Acanthosis nigricans not assessed in temporal communities.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Posted | Mean | Standard Error | percentage of 2-8 yo children | Baseline, 78 months | communities | communities |
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| Secondary | Change in Sugar Sweetened Beverage Intake | cups per day, determined from 2 random days of food records and weighted for weekend and weekday | Children 2 to 8 from communities randomized to CHL program or Control. Temporal communities not assessed for sugar sweetened beverage intake.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Posted | Mean | Standard Error | cups per day | change from baseline to 78 months | communities | communities |
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| Secondary | Change in Screen Time | Hours per day spent in screen activity | Children 2 to 8 randomized to CHL program or Control Community. Temporal community not assessed for screen time.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Posted | Mean | Standard Error | hours per day | change from Baseline to 78 months | communities | communities |
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| Secondary | Sleep Disturbance Score | 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. | Children 2 to 8y randomized to CHL program or Control Community. Temporal community not assessed for sleep disturbance. | Posted | Mean | Standard Error | units on a scale | 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. | communities | communities |
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| Secondary | Change in Water Intake | cups per day, determined from 2 random days of food records and weighted for weekend and weekday | Children 2 to 8 randomized to CHL program or Control Community. Temporal community not assessed for water intake.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Posted | Mean | Standard Error | cups per day | 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. | communities | communities |
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| Secondary | Change in Fruit Intake | cups per day, determined from 2 random days of food records and weighted for weekend and weekday | Children 2 to 8 randomized to CHL program or Control Community. Temporal community not assessed for fruit intake. | Posted | Mean | Standard Error | cups per day | change from baseline to 78 months | communities | communities |
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| Secondary | Change in Vegetable Intake | cups per day, determined from 2 random days of food records and weighted for weekend and weekday | Children 2 to 8y randomized to CHL program or Control Community. Temporal community not assessed for vegetable intake. | Posted | Mean | Standard Error | cups per day | change from baseline to 78 months | communities | communities |
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| Secondary | Change in Hours of Sleep Per Day | Sleep hours per day measure by questionnaire as reported by caregiver. | Children 2-8y in the selected Pacific communities.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Posted | Mean | Standard Error | hours per day | change from baseline to 78 months | communities | communities |
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| 0 |
| 3,359 |
| 0 |
| 3,359 |
| 0 |
| 3,359 |
| EG001 | Delayed Optimized CHL Program | Control community that participated in community engagement process and received delayed optimized program. | 0 | 3,265 | 0 | 3,265 | 0 | 3,265 |
| EG002 | Temporal | Communities assessed for temporal trends. | 0 | 3,216 | 0 | 3,216 | 0 | 3,216 |
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008548 | Melanosis |
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001519 | Behavior |
| Intervention vs temporal comparing 78 months to baseline. | Regression, Linear | The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | 0.49 | Mean Difference (Final Values) | 4.35 | 2-Sided | 95 | -8.5 | 17.24 | Superiority | Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities. |
| Superiority |
The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. |
| Intervention vs. Temporal communities. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Regression, Logistic | The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | 0.33 | The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Mean Difference (Final Values) | -3.43 | 2-Sided | 95 | -10.36 | 3.50 | Superiority | The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. |
| Superiority |
The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. |
| The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Regression, Linear | The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | 0.13 | The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Mean Difference (Final Values) | -0.65 | 2-Sided | 95 | -1.79 | 0.49 | Superiority | The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. |
Hierarchical |
The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. |
| Superiority |
The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. |
Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. |
Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. |
Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. |
| Intervention vs temporal.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Regression, Linear | The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | 0.51 | The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. | Mean Difference (Final Values) | 0.18 | 2-Sided | Superiority | Hierarchical model.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time. |