Acanthosis Nigricans, Central Obesity, Obesity
Conditions
Keywords
Obesity, Child, Food, Physical Activity, Pacific
Brief 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.
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.
Interventions
OTHERCHL program
Multiple component environmentally focused program designed with community engagement.
OTHERDelayed Optimized CHL program
CHL programs with fewer component and shorter duration.
Sponsors
University of Guam
Northern Marianas College
University of Alaska Fairbanks
American Samoa Community College
University of Hawaii
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Community randomized intervention for child obesity prevention with multiple levels and components (policy, environment, messaging, and capacity)
Eligibility
Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex | 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 | Baseline, 78 months | Waist circumference measured in centimeters at umbilicus. |
| Prevalence of Acanthosis Nigricans | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Screen Time | Change from Baseline to 24 months | Hours per day spent in screen activity |
| Sleep Disturbance Score | Change from Baseline to 24 months | 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 in Water Intake | Change from Baseline to 24 months | 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 in Sugar Sweetened Beverage Intake | Change from baseline to 24 months | cups per day, determined from 2 random days of food records and weighted for weekend and weekday |
| Change in Vegetable Intake | Change from baseline to 24 months | cups per day, determined from 2 random days of food records and weighted for weekend and weekday |
| Change in Metabolic Equivalents (METs) Per Day | Baseline, 24 months | number of minutes per day within bouts of 5 minutes averaged over 4 to 6 days of accelerometer usage |
| Change in Hours of Sleep Per Day | change from baseline to 24 months | Sleep hours per day measure by questionnaire as reported by caregiver. |
| Change in Fruit Intake | Change from baseline to 24 months | cups per day, determined from 2 random days of food records and weighted for weekend and weekday |
| Change in Mean of Moderate and Vigorous Activity Per Day in Minutes | Baseline, 24 months | number of minutes per day within bouts of 5 minutes averaged over 4 to 6 days of accelerometer usage |
| Change in Sedentary and Light Physical Activity | Baseline, 24 months | number of minutes per day within bouts of 5 minutes averaged over 4 to 6 days of accelerometer usage |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| CHL Program Multiple component environmentally focused intervention designed with a community engagement process.
CHL program: Multiple component environmentally focused program designed with community engagement. | 3,359 |
| CHL Program Multiple component environmentally focused intervention designed with a community engagement process.
CHL program: Multiple component environmentally focused program designed with community engagement. | 9 |
| Control Community Control community that participated in community engagement process and received delayed optimized program. | 3,265 |
| Control Community Control community that participated in community engagement process and received delayed optimized program. | 9 |
| Temporal Control community with limited interaction; for temporal change assessment of anthropometry. | 3,216 |
| Temporal Control community with limited interaction; for temporal change assessment of anthropometry. | 9 |
| Total | 9,867 |
Baseline characteristics
| Characteristic | CHL Program | Total | Temporal | Control Community |
|---|---|---|---|---|
| Age, Continuous | 5.42 years | 5.38 years | 5.22 years | 5.49 years |
| Race (NIH/OMB) American Indian or Alaska Native | 35 Participants | 278 Participants | 215 Participants | 28 Participants |
| Race (NIH/OMB) Asian | 186 Participants | 1064 Participants | 468 Participants | 410 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 57 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 842 Participants | 2425 Participants | 848 Participants | 735 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1940 Participants | 4956 Participants | 1281 Participants | 1735 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants | 67 Participants | 24 Participants | 21 Participants |
| Race (NIH/OMB) White | 302 Participants | 993 Participants | 363 Participants | 328 Participants |
| Region of Enrollment American Samoa | 682 Participants | 2094 Participants | 739 Participants | 673 Participants |
| Region of Enrollment Guam | 781 Participants | 1817 Participants | 277 Participants | 759 Participants |
| Region of Enrollment Northern Mariana Islands | 714 Participants | 2119 Participants | 717 Participants | 688 Participants |
| Region of Enrollment United States | 433 Participants | 1594 Participants | 736 Participants | 425 Participants |
| Region of Enrollment United States Minor Outlying Islands | 749 Participants | 2216 Participants | 747 Participants | 720 Participants |
| Sex: Female, Male Female | 1699 Participants | 4866 Participants | 1571 Participants | 1596 Participants |
| Sex: Female, Male Male | 1660 Participants | 4974 Participants | 1645 Participants | 1669 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3,359 | 0 / 3,265 | 0 / 3,216 |
| other Total, other adverse events | 0 / 3,359 | 0 / 3,265 | 0 / 3,216 |
| serious Total, serious adverse events | 0 / 3,359 | 0 / 3,265 | 0 / 3,216 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | 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 |
| Control Community | Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex | 1.4 percentage of 2 to 8 yo children | Standard Error 1.49 |
| Temporal | Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex | -0.40 percentage of 2 to 8 yo children | Standard Error 2 |
p-value: 0.0295% CI: [-7.29, -0.47]Regression, Logistic
Comparison: The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.p-value: 0.2895% CI: [-8.58, 3.32]Regression, Logistic
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | 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 |
| Control Community | Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex | 7.32 percentage of 2 to 8 yo children | Standard Error 0.11 |
| Temporal | Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex | -0.19 percentage of 2 to 8 yo children | Standard Error 0.11 |
Comparison: Intervention vs. control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.p-value: 0.00395% CI: [-20.92, -4.28]Regression, Logistic
Comparison: 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.p-value: 0.3395% CI: [-10.36, 3.5]Regression, Logistic
Primary
Change in Waist Circumference
Waist circumference measured in centimeters at umbilicus.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Change in Waist Circumference | 0.83 centimeters | Standard Error 0.05 |
| Control Community | Change in Waist Circumference | 2.47 centimeters | Standard Error 0.04 |
| Temporal | Change in Waist Circumference | 1.19 centimeters | Standard Error 0.03 |
Comparison: The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.p-value: 0.00995% CI: [-2.87, -0.41]Regression, Linear
Comparison: Intervention vs temporal comparing 78 months to baseline.p-value: 0.4995% CI: [-8.5, 17.24]Regression, Linear
Primary
Change in Waist Circumference
Waist circumference measured in centimeters at umbilicus.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CHL Program | Change in Waist Circumference | -0.12 centimeters |
| Control Community | Change in Waist Circumference | 0.59 centimeters |
| Temporal | Change in Waist Circumference | 0.54 centimeters |
Comparison: The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.p-value: 0.0295% CI: [-1.37, -0.05]Regression, Linear
Comparison: The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.p-value: 0.1395% CI: [-1.79, 0.49]Regression, Linear
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Prevalence of Acanthosis Nigricans | -4.1 percentage of 2-8 yo children | Standard Error 0.79 |
| Control Community | Prevalence of Acanthosis Nigricans | -0.5 percentage of 2-8 yo children | Standard Error 0.96 |
Comparison: Intervention vs control comparing 24 months to baseline.p-value: <0.01Regression, Logistic
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Prevalence of Acanthosis Nigricans | -4.1 percentage of 2-8 yo children | Standard Error 0.79 |
| Control Community | Prevalence of Acanthosis Nigricans | -0.5 percentage of 2-8 yo children | Standard Error 0.96 |
Comparison: intervention vs control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.p-value: <0.01Regression, Logistic
Secondary
Change in Fruit Intake
cups per day, determined from 2 random days of food records and weighted for weekend and weekday
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Change in Fruit Intake | -0.07 cups per day | Standard Error 0.03 |
| Control Community | Change in Fruit Intake | -0.05 cups per day | Standard Error 0.02 |
Comparison: Intervention vs control comparing 24 months to baseline.p-value: 0.54Regression, Linear
Secondary
Change in Fruit Intake
cups per day, determined from 2 random days of food records and weighted for weekend and weekday
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Change in Fruit Intake | 0.02 cups per day | Standard Error 0.06 |
| Control Community | Change in Fruit Intake | -0.19 cups per day | Standard Error 0.1 |
Comparison: Intervention vs. control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.p-value: 0.11Regression, Linear
Secondary
Change in Hours of Sleep Per Day
Sleep hours per day measure by questionnaire as reported by caregiver.
Time frame: change from baseline to 24 months
Population: Children 2-8y in the selected Pacific communities.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Change in Hours of Sleep Per Day | 0.07 hours per day | Standard Error 0.16 |
| Control Community | Change in Hours of Sleep Per Day | 0.25 hours per day | Standard Error 0.17 |
| Temporal | Change in Hours of Sleep Per Day | 0.09 hours per day | Standard Error 0.17 |
Comparison: Intervention vs control comparing 24 months to baseline.p-value: 0.48Regression, Linear
Secondary
Change in Hours of Sleep Per Day
Sleep hours per day measure by questionnaire as reported by caregiver.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Change in Hours of Sleep Per Day | 0.2 hours per day | Standard Error 0.18 |
| Control Community | Change in Hours of Sleep Per Day | 0 hours per day | Standard Error 0.11 |
| Temporal | Change in Hours of Sleep Per Day | 0.01 hours per day | Standard Error 0.2 |
Comparison: Intervention vs control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.p-value: 0.37Regression, Linear
Comparison: Intervention vs temporal.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.p-value: 0.51Regression, Linear
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
Time frame: Baseline, 24 months
Population: Children 2 to 8 randomized to CHL program or Control Community. Temporal community not assessed for physical activity.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | 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 |
| Control Community | Change in Mean of Moderate and Vigorous Activity Per Day in Minutes | -0.18 number of minutes per day within bouts o | Standard Error 1.8 |
Comparison: Intervention vs control comparing 24 months to baseline.p-value: 0.68Regression, Linear
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
Time frame: Baseline, 24 months
Population: Children 2 to 8y randomized to CHL program or Control Community. Temporal community not assessed for accelerometry.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Change in Metabolic Equivalents (METs) Per Day | -0.29 number of minutes per day within bouts o | Standard Error 0.09 |
| Control Community | Change in Metabolic Equivalents (METs) Per Day | -0.24 number of minutes per day within bouts o | Standard Error 0.09 |
Comparison: Intervention vs control comparing 24 months to baseline.p-value: 0.71Regression, Linear
Secondary
Change in Screen Time
Hours per day spent in screen activity
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Change in Screen Time | -0.2 hours per day | Standard Error 0.18 |
| Control Community | Change in Screen Time | 0.3 hours per day | Standard Error 0.22 |
Comparison: Intervention vs control comparing 24 months to baseline.p-value: 0.11Regression, Linear
Secondary
Change in Screen Time
Hours per day spent in screen activity
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Change in Screen Time | 0.006 hours per day | Standard Error 0.01 |
| Control Community | Change in Screen Time | 0.10 hours per day | Standard Error 0.02 |
Comparison: Intervention vs. Control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.p-value: 0.81Regression, Linear
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
Time frame: Baseline, 24 months
Population: Children 2 to 8 randomized to CHL program or Control Community. Temporal community not assessed for physical activity.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Change in Sedentary and Light Physical Activity | 1.78 number of minutes per day within bouts o | Standard Error 3.96 |
| Control Community | Change in Sedentary and Light Physical Activity | -1.64 number of minutes per day within bouts o | Standard Error 3.9 |
Comparison: Intervention vs control comparing 24 months to baseline.p-value: 0.55Regression, Linear
Secondary
Change in Sugar Sweetened Beverage Intake
cups per day, determined from 2 random days of food records and weighted for weekend and weekday
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Change in Sugar Sweetened Beverage Intake | -0.05 cups per day | Standard Error 0.08 |
| Control Community | Change in Sugar Sweetened Beverage Intake | -0.06 cups per day | Standard Error 0.04 |
Comparison: Intervention vs control comparing 24 months to baseline.p-value: 0.86Regression, Linear
Secondary
Change in Sugar Sweetened Beverage Intake
cups per day, determined from 2 random days of food records and weighted for weekend and weekday
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Change in Sugar Sweetened Beverage Intake | -0.05 cups per day | Standard Error 0.07 |
| Control Community | Change in Sugar Sweetened Beverage Intake | -0.14 cups per day | Standard Error 0.08 |
Comparison: Intervention vs Control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.p-value: 0.44Regression, Linear
Secondary
Change in Vegetable Intake
cups per day, determined from 2 random days of food records and weighted for weekend and weekday
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Change in Vegetable Intake | -0.01 cups per day | Standard Error 0.02 |
| Control Community | Change in Vegetable Intake | 0 cups per day | Standard Error 0.01 |
Comparison: Intervention vs control comparing 24 months to baseline.p-value: 0.9Regression, Linear
Secondary
Change in Vegetable Intake
cups per day, determined from 2 random days of food records and weighted for weekend and weekday
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Change in Vegetable Intake | 0 cups per day | Standard Error 0.05 |
| Control Community | Change in Vegetable Intake | -0.06 cups per day | Standard Error 0.04 |
Comparison: Intervention vs. control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.p-value: 0.4Regression, Linear
Secondary
Change in Water Intake
cups per day, determined from 2 random days of food records and weighted for weekend and weekday
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.
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Change in Water Intake | 0.02 cups per day | Standard Error 0.03 |
| Control Community | Change in Water Intake | 0 cups per day | Standard Error 0.02 |
Comparison: Intervention vs control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.p-value: 0.69Regression, Linear
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Change in Water Intake | 0.07 cups per day | Standard Error 0.06 |
| Control Community | Change in Water Intake | 0.11 cups per day | Standard Error 0.04 |
Comparison: Intervention vs control comparing 24 months to baseline.p-value: 0.71Regression, Linear
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.
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.
Population: Children 2 to 8y randomized to CHL program or Control Community. Temporal community not assessed for sleep disturbance.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Sleep Disturbance Score | 1.83 units on a scale | Standard Error 0.02 |
| Control Community | Sleep Disturbance Score | 1.46 units on a scale | Standard Error 0.05 |
Comparison: The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.p-value: 0.68Regression, Linear
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHL Program | Sleep Disturbance Score | -0.4 units on a scale | Standard Error 0.35 |
| Control Community | Sleep Disturbance Score | 0.3 units on a scale | Standard Error 0.19 |
Comparison: mixed model adjusting for age and sex and cluster of community and strata of jurisdiction; intervention vs control comparing 24 months to baselinep-value: 0.08Regression, Linear