Children's Healthy Living Community Randomized Trial

Obesity Clinical Trial

— CHL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881373
• Other study ID #: USDA 2011-68001-30335
• Secondary ID: 2011-68001-30335
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: March 2020

Study information

• Verified date: June 2023
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The specific objectives of our study are as follows.

Objective. Decrease the prevalence of young child overweight and obesity; and its functional outcomes (decrease acanthosis nigricans, and increase sleep; increase moderate to vigorous physical activity and decrease sedentary behavior (screen time); increase healthy eating (fruit and vegetable intake, water intake; decrease sweetened beverage intake), through community-based primary prevention environmental interventions in the Pacific region.

Objective. Measure 2-8-year-old children at baseline and 24 months in selected communities to track behaviors and anthropometry that indicate healthy eating, physical activity, and BMI.

Objective. Measure 2-8 year old children at 78 months in the selected communities to determine the long term effect of the CHL program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9840
• Est. completion date: March 2020
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Acanthosis Nigricans
• Central Obesity
• Obesity
• Obesity, Abdominal

Intervention

Other:
• CHL program
Multiple component environmentally focused program designed with community engagement.
• Delayed Optimized CHL program
CHL programs with fewer component and shorter duration.

Locations

Country	Name	City	State
United States	University of Hawaii	Honolulu	Hawaii

Sponsors (5)

Lead Sponsor	Collaborator
University of Hawaii	American Samoa Community College, Northern Marianas College, University of Alaska Fairbanks, University of Guam

Country where clinical trial is conducted

United States, 

References & Publications (26)

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. — View 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. — View 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 — View 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. — View Citation

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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View 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/ijerph160 — View Citation

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. — View Citation

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 — View Citation

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. — View 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. — View 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 He — View Citation

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. — View 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. — View 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. — View Citation

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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, 24 months
Primary	Change in Waist Circumference	Waist circumference measured in centimeters at umbilicus.	Baseline, 78 months
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).	Baseline, 24 months
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.	Baseline, 78 months
Primary	Change in Waist Circumference	Waist circumference measured in centimeters at umbilicus.	Baseline, 24 months
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).	Baseline, 78 months
Secondary	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
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	Baseline, 24 months
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	Baseline, 24 months
Secondary	Change in Screen Time	Hours per day spent in screen activity	Change from Baseline to 24 months
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.	Change from Baseline to 24 months
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.	Change from Baseline to 24 months
Secondary	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
Secondary	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
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	Baseline, 24 months
Secondary	Change in Hours of Sleep Per Day	Sleep hours per day measure by questionnaire as reported by caregiver.	change from baseline to 24 months
Secondary	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
Secondary	Change in Screen Time	Hours per day spent in screen activity	change from Baseline to 78 months
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.	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	Change in Hours of Sleep Per Day	Sleep hours per day measure by questionnaire as reported by caregiver.	change from baseline to 78 months

External Links

•   CHL program website