ObesityCHLNCT01881373

Children's Healthy Living Community Randomized Trial

A study testing CHL program and Delayed Optimized CHL program in people with Obesity and Acanthosis Nigricans, run by University of Hawaii at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 2 to 8 yearsHealthy volunteers can take part
Conditions the study is for: Obesity, Acanthosis Nigricans, Central Obesity
What is being tested?: CHL program and Delayed Optimized CHL program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9,840 participants
Where: 1 siteUnited States
Study dates: Nov 2012to Mar 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 8 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Show all 14Show fewer

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

Who cannot join

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.)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Hawaii
Honolulu, Hawaii, 96822

Other trials in United States

About this study

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

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.

Read the detailed description

The specific objectives of our study are as follows.

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

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

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: Obesity, Acanthosis Nigricans, Central Obesity
Being tested: CHL program, Delayed Optimized CHL program
Keywords: Obesity, Child, Food, Physical Activity, Pacific
Medical subject headings: Obesity, Acanthosis Nigricans, Obesity, Abdominal, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01881373
Study group	Role	What they receive
CHL program	Experimental	Multiple component environmentally focused intervention designed with a community engagement process. Receives: Other: CHL program
Delayed Optimized CHL program	Other	Comparison community that participated in community engagement process and received delayed optimized program. Receives: Other: Delayed Optimized CHL program
Temporal	No intervention	Communities assessed for temporal trends in anthropometry.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 24 months
Change in Waist Circumference
Waist circumference measured in centimeters at umbilicus.
Measured: 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).
Measured: 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.
Measured: Baseline, 78 months
Change in Waist Circumference
Waist circumference measured in centimeters at umbilicus.
Measured: 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).
Measured: Baseline, 78 months

Secondary outcomes (17)

Change in Sugar Sweetened Beverage Intake
cups per day, determined from 2 random days of food records and weighted for weekend and weekday
Measured: Change from baseline to 24 months
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
Measured: 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
Measured: Baseline, 24 months
Change in Screen Time
Hours per day spent in screen activity
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 24 months
Change in Hours of Sleep Per Day
Sleep hours per day measure by questionnaire as reported by caregiver.
Measured: 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
Measured: change from baseline to 78 months
Change in Screen Time
Hours per day spent in screen activity
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: change from baseline to 78 months
Change in Hours of Sleep Per Day
Sleep hours per day measure by questionnaire as reported by caregiver.
Measured: change from baseline to 78 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Mar 2020

First posted19 Jun 2013 (estimated)
Study startNov 2012
Primary completionAug 2015
Study completionMar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (29)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Community randomized intervention for child obesity prevention with multiple levels and components (policy, environment, messaging, and capacity)
Masking: None (open label)
Enrolment: 9,840 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01881373
Sponsor's protocol ID: USDA 2011-68001-30335
Other IDs: 2011-68001-30335, 2018-69001-27551, 2018
Acronym: CHL
Status last verified: Jun 2023
First submitted: 17 Jun 2013
Last updated: 4 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Request system whereby researchers submit a proposal, if approved by CHL steering committee, data is released using secure systems

Publications

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.
PubMed 24043557
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.
PubMed 24107083
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.
PubMed 24251089
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.
PubMed 25369548
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.
PubMed 25393168
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.
PubMed 25981090
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.
PubMed 26622918
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.
PubMed 26457888
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.
PubMed 31861756
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.
PubMed 34166179
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.
PubMed 30431465
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.
PubMed 32825433
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.
PubMed 34278324
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.
PubMed 32666055
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.
PubMed 29398780

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Children's Healthy Living Program for Remote Underserved Minority Populations in the Pacific Region
ClinicalTrials.gov ID: NCT01881373
Acronym / sponsor ID: CHL / USDA 2011-68001-30335
Conditions: Obesity, Acanthosis Nigricans, Central Obesity
Keywords: Obesity, Child, Food, Physical Activity, Pacific
Study type: Interventional
Recruitment status: Completed
Enrolment: 9,840 participants (actual)
Lead sponsor: University of HawaiiUniversity, hospital or other
Collaborators: University of Guam, Northern Marianas College, University of Alaska Fairbanks, American Samoa Community College
Study start: Nov 2012 (actual)
Primary completion: Aug 2015 (actual)
Study completion: Mar 2020 (actual)
First posted: 19 Jun 2013 (estimated)
Results: Posted 1 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The specific objectives of our study are as follows.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Community randomized intervention for child obesity prevention with multiple levels and components (policy, environment, messaging, and capacity)

Arm	Type	Receives
CHL program	Experimental	Other: CHL programMultiple component environmentally focused intervention designed with a community engagement process.
Delayed Optimized CHL program	Other	Other: Delayed Optimized CHL programComparison community that participated in community engagement process and received delayed optimized program.
Temporal	No intervention	–Communities assessed for temporal trends in anthropometry.

Who may qualify

Ages: 2 to 8 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (14 listed)

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
CHL Staff Community Evaluation
Child criteria • 2-10 years of age

Key exclusion criteria (4 listed)

Child criteria

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CHL programMultiple component environmentally focused program designed with community engagement.	Other	CHL program
Delayed Optimized CHL programCHL programs with fewer component and shorter duration.	Other	Delayed Optimized CHL program

Primary outcome

Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex
Time frame: Baseline, 24 months
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.
Change in Waist Circumference
Time frame: Baseline, 78 months
Waist circumference measured in centimeters at umbilicus.
Prevalence of Acanthosis Nigricans
Time frame: Baseline, 24 months
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).
Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex
Time frame: Baseline, 78 months
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.
Change in Waist Circumference
Time frame: Baseline, 24 months
Waist circumference measured in centimeters at umbilicus.
Prevalence of Acanthosis Nigricans
Time frame: Baseline, 78 months
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).

17 secondary outcomes

Change in Sugar Sweetened Beverage Intake
Time frame: Change from baseline to 24 months
Change in Mean of Moderate and Vigorous Activity Per Day in Minutes
Time frame: Baseline, 24 months
Change in Sedentary and Light Physical Activity
Time frame: Baseline, 24 months
Change in Screen Time
Time frame: Change from Baseline to 24 months
Sleep Disturbance Score
Time frame: Change from Baseline to 24 months
Change in Water Intake
Time frame: Change from Baseline to 24 months
Change in Fruit Intake
Time frame: Change from baseline to 24 months
Change in Vegetable Intake
Time frame: Change from baseline to 24 months
Change in Metabolic Equivalents (METs) Per Day
Time frame: Baseline, 24 months
Change in Hours of Sleep Per Day
Time frame: change from baseline to 24 months
Change in Sugar Sweetened Beverage Intake
Time frame: change from baseline to 78 months
Change in Screen Time
Time frame: change from Baseline to 78 months
Sleep Disturbance Score
Time frame: 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
Time frame: 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
Time frame: change from baseline to 78 months
Change in Vegetable Intake
Time frame: change from baseline to 78 months
Change in Hours of Sleep Per Day
Time frame: change from baseline to 78 months

Results and safety

Results posted to the registry on 1 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CHL Program	1,517	1,517
Delayed Optimized CHL Program	1,491	1,491
Temporal	1,321	1,321

Primary outcome: Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex

Time frame: Baseline, 24 months. Mean (Standard Error). Unit: percentage of 2 to 8 yo children

Measure	CHL Program n = 2859	Control Community n = 2786	Temporal n = 2726
Value	-2.8 (1.16)	1.4 (1.49)	-0.40 (2.0)

CHL Program vs Control Community: Mean Difference (Final Values): -3.88 (95% CI -7.29 to -0.47), p = 0.02, Regression, Logistic
CHL Program vs Temporal: Mean Difference (Final Values): -2.63 (95% CI -8.58 to 3.32), p = 0.28, Regression, Logistic

Population analysed: 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.

Primary outcome: Change in Waist Circumference

Time frame: Baseline, 78 months. Mean (Standard Error). Unit: centimeters

Measure	CHL Program n = 2017	Control Community n = 1970	Temporal n = 1811
Value	0.83 (0.05)	2.47 (0.04)	1.19 (0.03)

CHL Program vs Control Community: Mean Difference (Final Values): -1.64 (95% CI -2.87 to -0.41), p = 0.009, Regression, Linear
CHL Program vs Temporal: Mean Difference (Final Values): 4.35 (95% CI -8.5 to 17.24), p = 0.49, Regression, Linear

Population analysed: 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.

Primary outcome: Prevalence of Acanthosis Nigricans

Time frame: Baseline, 24 months. Mean (Standard Error). Unit: percentage of 2-8 yo children

Measure	CHL Program n = 2859	Control Community n = 2786	Temporal Community n = 0
Value	-4.1 (0.79)	-0.5 (0.96)	–

CHL Program vs Control Community: Difference in prevalence: -3.6, p <0.01, Regression, Logistic

Population analysed: 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.

Primary outcome: Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex

Time frame: Baseline, 78 months. Mean (Standard Error). Unit: percentage of 2 to 8 yo children

Measure	CHL Program n = 2017	Control Community n = 1970	Temporal n = 1811
Value	-5.28 (0.17)	7.32 (0.11)	-0.19 (0.11)

CHL Program vs Control Community: change in prevalence between communities: -12.6 (95% CI -20.92 to -4.28), p = 0.003, Regression, Logistic
CHL Program vs Temporal: Mean Difference (Final Values): -3.43 (95% CI -10.36 to 3.50), p = 0.33, Regression, Logistic

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: The children representing the communities were observed for the assessment periods only.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CHL Program	0 of 3,359 (0%)	0 of 3,359 (0%)	0 of 3,359
Delayed Optimized CHL Program	0 of 3,265 (0%)	0 of 3,265 (0%)	0 of 3,265
Temporal	0 of 3,216 (0%)	0 of 3,216 (0%)	0 of 3,216

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24043557Fialkowski 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.
Background: PubMed 24107083Wilken 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.
Background: PubMed 24251089Novotny 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.
Background: PubMed 25369548Braun 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.
Background: PubMed 25393168Novotny 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.
Background: PubMed 25981090Fialkowski 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.
Background: PubMed 26622918Butel 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.
Background: PubMed 26457888Li 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.
Background: PubMed 31861756Aflague 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.
Background: PubMed 34166179Yamanaka 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.
Background: PubMed 30431465Butel 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.
Background: PubMed 32825433Leon 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.
CHL program websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Request system whereby researchers submit a proposal, if approved by CHL steering committee, data is released using secure systems

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rachel Novotny, PhD principal investigator

University of Hawaii

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CHL program and Delayed Optimized CHL program in people with Obesity and Acanthosis Nigricans, run by University of Hawaii at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex (time frame: Baseline, 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01881373, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.