Trial Outcomes & Findings for Improving High School Breakfast Environments (NCT NCT02004977)
NCT ID: NCT02004977
Last Updated: 2018-01-23
Results Overview
Change in participation in the reimbursable school breakfast program will be evaluated from school provided objective participation data from baseline (SY1) to the end of one school year (SY2)
COMPLETED
NA
904 participants
Change from baseline (SY1) in average school year school-level breakfast participation at the end of one school year (SY2).
2018-01-23
Participant Flow
Participant milestones
| Measure |
Intervention Arm
The role of the intervention arm (schools) is to improve access to the school breakfast program
Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools.
|
Comparison Arm
the role of the comparison arm (schools) is to maintain usual breakfast program at school
|
|---|---|---|
|
Overall Study
STARTED
|
463
|
441
|
|
Overall Study
COMPLETED
|
409
|
436
|
|
Overall Study
NOT COMPLETED
|
54
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving High School Breakfast Environments
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=463 Participants
The role of the intervention arm (schools) is to improve access to the school breakfast program
Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools.
|
Comparison Arm
n=441 Participants
the role of the comparison arm (schools) is to maintain usual breakfast program at school
|
Total
n=904 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
463 Participants
n=5 Participants
|
441 Participants
n=7 Participants
|
904 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
|
15.2 years
STANDARD_DEVIATION .8 • n=5 Participants
|
15.1 years
STANDARD_DEVIATION .8 • n=7 Participants
|
15.2 years
STANDARD_DEVIATION .8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
254 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
491 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
209 Participants
n=5 Participants
|
204 Participants
n=7 Participants
|
413 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
283 Participants
n=5 Participants
|
314 Participants
n=7 Participants
|
597 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American or Alaska Native
|
21 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
23 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
105 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
463 participants
n=5 Participants
|
441 participants
n=7 Participants
|
904 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline (SY1) in average school year school-level breakfast participation at the end of one school year (SY2).Change in participation in the reimbursable school breakfast program will be evaluated from school provided objective participation data from baseline (SY1) to the end of one school year (SY2)
Outcome measures
| Measure |
Intervention Arm
n=8 Schools
The role of the intervention arm (schools) is to improve access to the school breakfast program
Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools.
|
Comparison Arm
n=8 Schools
the role of the comparison arm (schools) is to maintain usual breakfast program at school
|
|---|---|---|
|
Change From Baseline in Percent Students Eating the School Breakfast Per School
|
8.3 % School Breakfast Participation
Standard Deviation 9.8
|
.9 % School Breakfast Participation
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Change from baseline (SY1) in student body mass index at the end of one school year (SY2).Population: The number of participants does not match that the the flow chart, and we were not able to to get post (SY2) BMI measures in all of the enrolled students.
Change from baseline to the end of one school year (SY2) in body mass index.
Outcome measures
| Measure |
Intervention Arm
n=389 Participants
The role of the intervention arm (schools) is to improve access to the school breakfast program
Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools.
|
Comparison Arm
n=390 Participants
the role of the comparison arm (schools) is to maintain usual breakfast program at school
|
|---|---|---|
|
Change From Baseline in Body Mass Index
|
1.0 kg/m^2
Standard Deviation 1.8
|
.9 kg/m^2
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Change from baseline in student body fat at the end of the school year (SY2)Population: The number of participants does not match that the the flow chart, and we were not able to to get post (SY2) % body fat measures in all of the enrolled students.
Student percent body fat will be measured by trained research staff
Outcome measures
| Measure |
Intervention Arm
n=389 Participants
The role of the intervention arm (schools) is to improve access to the school breakfast program
Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools.
|
Comparison Arm
n=390 Participants
the role of the comparison arm (schools) is to maintain usual breakfast program at school
|
|---|---|---|
|
Change From Baseline in Percent Body Fat
|
.1 % Body Fat
Standard Deviation 4.3
|
-.2 % Body Fat
Standard Deviation 3.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline in Healthy Eating Index at the end of the school year (SY2).Population: The number of participants does not match that the the flow chart, and we were not able to to get post (SY2) HEI measures in all of the enrolled students.
Change in the total Healthy Eating Index score from baseline to SY2. The Healthy Eating Index (HEI) score is a measure of diet quality. HEI scores can range from 0 to 100, with 0 representing the least overall healthy diet, and 100 representing the most overall healthy diet
Outcome measures
| Measure |
Intervention Arm
n=282 Participants
The role of the intervention arm (schools) is to improve access to the school breakfast program
Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools.
|
Comparison Arm
n=290 Participants
the role of the comparison arm (schools) is to maintain usual breakfast program at school
|
|---|---|---|
|
Change From Baseline in Healthy Eating Index Scores
|
.6 Healthy Eating Index Total Score
Standard Deviation 15.0
|
-.3 Healthy Eating Index Total Score
Standard Deviation 12.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change in perceived support from baseline at the end of the school year (SY2)Change in social support from baseline to SY2. Assessment of social support for breakfast was measured by asking the students to consider a typical month and record how often the following people encouraged them to eat or continue to eat breakfast at school: (1) parent/guardian, (2) friend, (3) other kids at my school, (4) teacher, and (5) other school staff. A 4-point Likert-type scale (disagree to agree, 0-4) for each of the categories was used. The total scale summed the five categories. The scale ranged from 0-20, a higher score indicates more social support.
Outcome measures
| Measure |
Intervention Arm
n=463 Participants
The role of the intervention arm (schools) is to improve access to the school breakfast program
Improve access to the school breakfast program: Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools.
|
Comparison Arm
n=441 Participants
the role of the comparison arm (schools) is to maintain usual breakfast program at school
|
|---|---|---|
|
Social Support
|
.3 scores on a scale
Standard Deviation 3.4
|
-.2 scores on a scale
Standard Deviation 3.9
|
Adverse Events
Comparison Arm
Intervention Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place