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Trial Outcomes & Findings for Addressing Health Disparities in Childhood Obesity, One Summer at a Time (NCT NCT03595332)

NCT ID: NCT03595332

Last Updated: 2022-10-05

Results Overview

Body mass index (BMI) will be calculated as kg/m2 and BMI-percentile score calculated using the L, M, S parameters published by the Centre for Disease Control and Prevention. BMI Percentile-score are measures of relative weight adjusted for child age and sex. The percentile indicates value relative to reference populations for age and sex, with at or below 5th percentile indicating the child being underweight, between 5 and 85th percentile as having a healthy weight, 85th to 95th percentile as being overweight and 95th percentile and above indicative of having obesity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

222 participants

Primary outcome timeframe

Measured at baseline and 10-weeks after baseline

Results posted on

2022-10-05

Participant Flow

Participant milestones

Participant milestones
Measure
Immediate Intervention
Summer activity program: Children will receive the summer scorecard program during the first summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise.
Delayed Intervention
Summer activity program: Children will receive the summer scorecard program during the second summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise.
Overall Study
STARTED
92
130
Overall Study
COMPLETED
76
106
Overall Study
NOT COMPLETED
16
24

Reasons for withdrawal

Reasons for withdrawal
Measure
Immediate Intervention
Summer activity program: Children will receive the summer scorecard program during the first summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise.
Delayed Intervention
Summer activity program: Children will receive the summer scorecard program during the second summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise.
Overall Study
Lost to Follow-up
16
22
Overall Study
Unable to retrieve ID from school
0
2

Baseline Characteristics

Addressing Health Disparities in Childhood Obesity, One Summer at a Time

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Immediate Intervention
n=92 Participants
Summer activity program: Children will receive the summer scorecard program during the first summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise.
Delayed Intervention
n=130 Participants
Summer activity program: Children will receive the summer scorecard program during the second summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise.
Total
n=222 Participants
Total of all reporting groups
Age, Categorical
<=18 years
92 Participants
n=5 Participants
130 Participants
n=7 Participants
222 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
8.80 years
STANDARD_DEVIATION 1.86 • n=5 Participants
9.29 years
STANDARD_DEVIATION 1.61 • n=7 Participants
9.09 years
STANDARD_DEVIATION 1.73 • n=5 Participants
Sex: Female, Male
Female
56 Participants
n=5 Participants
57 Participants
n=7 Participants
113 Participants
n=5 Participants
Sex: Female, Male
Male
36 Participants
n=5 Participants
73 Participants
n=7 Participants
109 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · White
15 Participants
n=5 Participants
40 Participants
n=7 Participants
55 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
42 Participants
n=5 Participants
42 Participants
n=7 Participants
84 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · American Indian/Alaskan Native
25 Participants
n=5 Participants
47 Participants
n=7 Participants
72 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Native Hawaiian/Pacific Islander
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Black
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Two or more
5 Participants
n=5 Participants
0 Participants
n=7 Participants
5 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Unknown
4 Participants
n=5 Participants
0 Participants
n=7 Participants
4 Participants
n=5 Participants
Region of Enrollment
United States
92 participants
n=5 Participants
130 participants
n=7 Participants
222 participants
n=5 Participants
Baseline BMI%
59.53 Percentile
STANDARD_DEVIATION 30.08 • n=5 Participants
66.23 Percentile
STANDARD_DEVIATION 32.02 • n=7 Participants
63.43 Percentile
STANDARD_DEVIATION 31.32 • n=5 Participants

PRIMARY outcome

Timeframe: Measured at baseline and 10-weeks after baseline

Body mass index (BMI) will be calculated as kg/m2 and BMI-percentile score calculated using the L, M, S parameters published by the Centre for Disease Control and Prevention. BMI Percentile-score are measures of relative weight adjusted for child age and sex. The percentile indicates value relative to reference populations for age and sex, with at or below 5th percentile indicating the child being underweight, between 5 and 85th percentile as having a healthy weight, 85th to 95th percentile as being overweight and 95th percentile and above indicative of having obesity.

Outcome measures

Outcome measures
Measure
Immediate Intervention
n=76 Participants
Summer activity program: Children will receive the summer scorecard program during the first summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise.
Delayed Intervention
n=106 Participants
Summer activity program: Children will receive the summer scorecard program during the second summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise.
Body Mass Index Percentile Score Change at 10 Weeks
0.307 Percentile
Standard Deviation 0.967
1.755 Percentile
Standard Deviation 1.560

PRIMARY outcome

Timeframe: Baseline to 10 weeks

Population: This analysis includes only those children who were overweight by CDC standards (equal or greater to 85th percentile for age and sex), as they were the high-risk group of interest for the study.

Body mass index (BMI) will be calculated as kg/m2 and BMI percentile calculated using the L, M, S parameters published by the Centre for Disease Control and Prevention. BMI percentiles are measures of relative weight adjusted for child age and sex. This analysis includes only those children who were overweight by CDC standards (equal or greater to 85th percentile for age and sex), as they were the high-risk group of interest for the study.

Outcome measures

Outcome measures
Measure
Immediate Intervention
n=23 Participants
Summer activity program: Children will receive the summer scorecard program during the first summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise.
Delayed Intervention
n=54 Participants
Summer activity program: Children will receive the summer scorecard program during the second summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise.
Overweight Participants Body Mass Index Percentile Score Change
-2.632 Percentile
Standard Error 1.594
-3.444 Percentile
Standard Error 1.836

SECONDARY outcome

Timeframe: Measured 1-year after baseline

Population: The delayed intervention group 1-year BMI Percentile follow-up was not possible as all schools closed in March 2020 with no measurements allowed over the next year. Of the 76 children (of 92 total) in the immediate intervention group who completed any follow-up measurements, 64 completed 1-year measurements.

Body mass index (BMI) will be calculated as kg/m2 and BMI-Percentile score calculated using the L, M, S parameters published by the Centre for Disease Control and Prevention. BMI Percentile-score are measures of relative weight adjusted for child age and sex.

Outcome measures

Outcome measures
Measure
Immediate Intervention
n=64 Participants
Summer activity program: Children will receive the summer scorecard program during the first summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise.
Delayed Intervention
Summer activity program: Children will receive the summer scorecard program during the second summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise.
Body Mass Index Percentile Score Change at 1 Year
0.363 Percentile
Standard Error 1.676
—

SECONDARY outcome

Timeframe: Measured at baseline and at 10-weeks (after summer program)

During your free time on most days, how likely will you do physical activities? with Likert type 5-answer options (1,2,3,4 or 5) ranging from (1) "I will not be active" to (5) "For sure I will be active". The minimum score is 1, maximum score is 5. Higher scores mean greater intentions to engage in physical activity.

Outcome measures

Outcome measures
Measure
Immediate Intervention
n=76 Participants
Summer activity program: Children will receive the summer scorecard program during the first summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise.
Delayed Intervention
n=106 Participants
Summer activity program: Children will receive the summer scorecard program during the second summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise.
Change in Intention to Engage in Physical Activity From Baseline to 10 Weeks
0.238 score on a scale
Standard Error 0.222
0.311 score on a scale
Standard Error 0.154

Adverse Events

Immediate Intervention: Immediate Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Immediate Intervention: Delayed Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Delayed Intervention: Immediate Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Delayed Intervention: Delayed Group

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

Dr. Hendrik de Heer

Northern Arizona University

Phone: 9285231499

Results disclosure agreements

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