Trial Outcomes & Findings for Children's Healthy Living Community Randomized Trial (NCT NCT01881373)

NCT ID: NCT01881373

Last Updated: 2024-03-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9840 participants
• Primary outcome timeframe: Baseline, 24 months
• Results posted on: 2024-03-04

Participant Flow

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

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.

Unit of analysis: Communities

Participant milestones

Measure	CHL Program Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Delayed Optimized CHL Program Comparison community that participated in community engagement process and received delayed optimized program.	Temporal Communities assessed for temporal trends
Baseline STARTED	1517 9	1491 9	1321 9
Baseline COMPLETED	1517 9	1491 9	1321 9
Baseline NOT COMPLETED	0 0	0 0	0 0
24 Months STARTED	1342 9	1295 9	1405 9
24 Months COMPLETED	1342 9	1295 9	1405 9
24 Months NOT COMPLETED	0 0	0 0	0 0
78 Months STARTED	500 9	479 9	490 9
78 Months COMPLETED	500 9	479 9	490 9
78 Months NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Children's Healthy Living Community Randomized Trial

Baseline characteristics by cohort

Measure	CHL Program n=9 community Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 community Control community that participated in community engagement process and received delayed optimized program.	Temporal n=9 community Control community with limited interaction; for temporal change assessment of anthropometry.	Total n=27 community Total of all reporting groups
Age, Continuous	5.42 years n=5 Participants	5.49 years n=7 Participants	5.22 years n=5 Participants	5.38 years n=4 Participants
Sex: Female, Male Female	1699 Participants n=5 Participants	1596 Participants n=7 Participants	1571 Participants n=5 Participants	4866 Participants n=4 Participants
Sex: Female, Male Male	1660 Participants n=5 Participants	1669 Participants n=7 Participants	1645 Participants n=5 Participants	4974 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	35 Participants n=5 Participants	28 Participants n=7 Participants	215 Participants n=5 Participants	278 Participants n=4 Participants
Race (NIH/OMB) Asian	186 Participants n=5 Participants	410 Participants n=7 Participants	468 Participants n=5 Participants	1064 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1940 Participants n=5 Participants	1735 Participants n=7 Participants	1281 Participants n=5 Participants	4956 Participants n=4 Participants
Race (NIH/OMB) Black or African American	32 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants	57 Participants n=4 Participants
Race (NIH/OMB) White	302 Participants n=5 Participants	328 Participants n=7 Participants	363 Participants n=5 Participants	993 Participants n=4 Participants
Race (NIH/OMB) More than one race	842 Participants n=5 Participants	735 Participants n=7 Participants	848 Participants n=5 Participants	2425 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants	21 Participants n=7 Participants	24 Participants n=5 Participants	67 Participants n=4 Participants
Region of Enrollment Northern Mariana Islands	714 Participants n=5 Participants	688 Participants n=7 Participants	717 Participants n=5 Participants	2119 Participants n=4 Participants
Region of Enrollment Guam	781 Participants n=5 Participants	759 Participants n=7 Participants	277 Participants n=5 Participants	1817 Participants n=4 Participants
Region of Enrollment American Samoa	682 Participants n=5 Participants	673 Participants n=7 Participants	739 Participants n=5 Participants	2094 Participants n=4 Participants
Region of Enrollment United States	433 Participants n=5 Participants	425 Participants n=7 Participants	736 Participants n=5 Participants	1594 Participants n=4 Participants
Region of Enrollment United States Minor Outlying Islands	749 Participants n=5 Participants	720 Participants n=7 Participants	747 Participants n=5 Participants	2216 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 24 months

Population: 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.

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.

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal n=9 communities Communities measured for temporal trends
Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex	-2.8 percentage of 2 to 8 yo children Standard Error 1.16	1.4 percentage of 2 to 8 yo children Standard Error 1.49	-0.40 percentage of 2 to 8 yo children Standard Error 2.0

PRIMARY outcome

Timeframe: Baseline, 78 months

Population: 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.

Waist circumference measured in centimeters at umbilicus.

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal n=9 communities Communities measured for temporal trends
Change in Waist Circumference	0.83 centimeters Standard Error 0.05	2.47 centimeters Standard Error 0.04	1.19 centimeters Standard Error 0.03

PRIMARY outcome

Timeframe: Baseline, 24 months

Population: 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.

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).

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal Communities measured for temporal trends
Prevalence of Acanthosis Nigricans	-4.1 percentage of 2-8 yo children Standard Error 0.79	-0.5 percentage of 2-8 yo children Standard Error 0.96	—

PRIMARY outcome

Timeframe: Baseline, 78 months

Population: 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.

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.

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal n=9 communities Communities measured for temporal trends
Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex	-5.28 percentage of 2 to 8 yo children Standard Error 0.17	7.32 percentage of 2 to 8 yo children Standard Error 0.11	-0.19 percentage of 2 to 8 yo children Standard Error 0.11

PRIMARY outcome

Timeframe: Baseline, 24 months

Population: 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.

Waist circumference measured in centimeters at umbilicus.

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal n=9 communities Communities measured for temporal trends
Change in Waist Circumference	-0.12 centimeters Interval -0.72 to 0.49	0.59 centimeters Interval 0.33 to 0.85	0.54 centimeters Interval -0.14 to 1.21

PRIMARY outcome

Timeframe: Baseline, 78 months

Population: 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.

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).

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal Communities measured for temporal trends
Prevalence of Acanthosis Nigricans	-4.1 percentage of 2-8 yo children Standard Error 0.79	-0.5 percentage of 2-8 yo children Standard Error 0.96	—

SECONDARY outcome

Timeframe: Change from baseline to 24 months

Population: 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.

cups per day, determined from 2 random days of food records and weighted for weekend and weekday

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal Communities measured for temporal trends
Change in Sugar Sweetened Beverage Intake	-0.05 cups per day Standard Error 0.08	-0.06 cups per day Standard Error 0.04	—

SECONDARY outcome

Timeframe: Baseline, 24 months

Population: Children 2 to 8 randomized to CHL program or Control Community. Temporal community not assessed for physical activity.

number of minutes per day within bouts of 5 minutes averaged over 4 to 6 days of accelerometer usage

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal Communities measured for temporal trends
Change in Mean of Moderate and Vigorous Activity Per Day in Minutes	-1.35 number of minutes per day within bouts o Standard Error 1.82	-0.18 number of minutes per day within bouts o Standard Error 1.80	—

SECONDARY outcome

Timeframe: Baseline, 24 months

Population: Children 2 to 8 randomized to CHL program or Control Community. Temporal community not assessed for physical activity.

number of minutes per day within bouts of 5 minutes averaged over 4 to 6 days of accelerometer usage

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal Communities measured for temporal trends
Change in Sedentary and Light Physical Activity	1.78 number of minutes per day within bouts o Standard Error 3.96	-1.64 number of minutes per day within bouts o Standard Error 3.90	—

SECONDARY outcome

Timeframe: Change from Baseline to 24 months

Population: 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.

Hours per day spent in screen activity

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal Communities measured for temporal trends
Change in Screen Time	-0.2 hours per day Standard Error 0.18	0.3 hours per day Standard Error 0.22	—

SECONDARY outcome

Timeframe: Change from Baseline to 24 months

Population: 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.

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.

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal Communities measured for temporal trends
Sleep Disturbance Score	-0.4 units on a scale Standard Error 0.35	0.3 units on a scale Standard Error 0.19	—

SECONDARY outcome

Timeframe: Change from Baseline to 24 months

Population: Children 2 to 8 randomized to CHL program or Control Community. Temporal community not assessed for 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.

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal Communities measured for temporal trends
Change in Water Intake	0.07 cups per day Standard Error 0.06	0.11 cups per day Standard Error 0.04	—

SECONDARY outcome

Timeframe: Change from baseline to 24 months

Population: Children 2 to 8 randomized to CHL program or Control Community. Temporal community not assessed for fruit intake.

cups per day, determined from 2 random days of food records and weighted for weekend and weekday

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal Communities measured for temporal trends
Change in Fruit Intake	-0.07 cups per day Standard Error 0.03	-0.05 cups per day Standard Error 0.02	—

SECONDARY outcome

Timeframe: Change from baseline to 24 months

Population: Children 2 to 8y randomized to CHL program or Control Community. Temporal community not assessed for vegetable intake.

cups per day, determined from 2 random days of food records and weighted for weekend and weekday

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal Communities measured for temporal trends
Change in Vegetable Intake	-0.01 cups per day Standard Error 0.02	0 cups per day Standard Error 0.01	—

SECONDARY outcome

Timeframe: Baseline, 24 months

Population: Children 2 to 8y randomized to CHL program or Control Community. Temporal community not assessed for accelerometry.

number of minutes per day within bouts of 5 minutes averaged over 4 to 6 days of accelerometer usage

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal Communities measured for temporal trends
Change in Metabolic Equivalents (METs) Per Day	-0.29 number of minutes per day within bouts o Standard Error 0.09	-0.24 number of minutes per day within bouts o Standard Error 0.09	—

SECONDARY outcome

Timeframe: change from baseline to 24 months

Population: Children 2-8y in the selected Pacific communities.

Sleep hours per day measure by questionnaire as reported by caregiver.

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal n=9 communities Communities measured for temporal trends
Change in Hours of Sleep Per Day	0.07 hours per day Standard Error 0.16	0.25 hours per day Standard Error 0.17	0.09 hours per day Standard Error 0.17

SECONDARY outcome

Timeframe: change from baseline to 78 months

Population: 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.

cups per day, determined from 2 random days of food records and weighted for weekend and weekday

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal Communities measured for temporal trends
Change in Sugar Sweetened Beverage Intake	-0.05 cups per day Standard Error 0.07	-0.14 cups per day Standard Error 0.08	—

SECONDARY outcome

Timeframe: change from Baseline to 78 months

Population: 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.

Hours per day spent in screen activity

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal Communities measured for temporal trends
Change in Screen Time	0.006 hours per day Standard Error 0.01	0.10 hours per day Standard Error 0.02	—

SECONDARY outcome

Timeframe: 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.

Population: Children 2 to 8y randomized to CHL program or Control Community. Temporal community not assessed for sleep disturbance.

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.

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal Communities measured for temporal trends
Sleep Disturbance Score	1.83 units on a scale Standard Error 0.02	1.46 units on a scale Standard Error 0.05	—

SECONDARY outcome

Timeframe: 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.

Population: 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.

cups per day, determined from 2 random days of food records and weighted for weekend and weekday

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal Communities measured for temporal trends
Change in Water Intake	0.02 cups per day Standard Error 0.03	0 cups per day Standard Error 0.02	—

SECONDARY outcome

Timeframe: change from baseline to 78 months

Population: Children 2 to 8 randomized to CHL program or Control Community. Temporal community not assessed for fruit intake.

cups per day, determined from 2 random days of food records and weighted for weekend and weekday

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal Communities measured for temporal trends
Change in Fruit Intake	0.02 cups per day Standard Error 0.06	-0.19 cups per day Standard Error 0.10	—

SECONDARY outcome

Timeframe: change from baseline to 78 months

Population: Children 2 to 8y randomized to CHL program or Control Community. Temporal community not assessed for vegetable intake.

cups per day, determined from 2 random days of food records and weighted for weekend and weekday

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal Communities measured for temporal trends
Change in Vegetable Intake	0 cups per day Standard Error 0.05	-0.06 cups per day Standard Error 0.04	—

SECONDARY outcome

Timeframe: change from baseline to 78 months

Population: 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.

Sleep hours per day measure by questionnaire as reported by caregiver.

Outcome measures

Measure	CHL Program n=9 communities Multiple component environmentally focused intervention designed with a community engagement process. CHL program: Multiple component environmentally focused program designed with community engagement.	Control Community n=9 communities Comparison community that participated in community engagement process and will receive delayed optimized program.	Temporal n=9 communities Communities measured for temporal trends
Change in Hours of Sleep Per Day	0.2 hours per day Standard Error 0.18	0 hours per day Standard Error 0.11	0.01 hours per day Standard Error 0.2

Adverse Events

CHL Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed Optimized CHL Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Temporal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rachel Novotny

University of Hawaii

Phone: 808-956-3848

Email: novotny@hawaii.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place