Obesity
Conditions
Brief summary
The goals of this intervention study are to implement best practice strategies to expand and promote the school breakfast program and test the impact upon student participation rates among a) all 10th and 11th grade students and among a randomly selected cohort of 800 students b) total diet and body mass index and percent body fat inin 16 rural Minnesota school districts. School-wide Primary Aim: Improve participation in the school breakfast program among high school students. Hypothesis: School-wide school breakfast program participation will be higher in the intervention versus comparison group.
Detailed description
We will accomplish the following secondary aims using a random subsample of 800 incoming 10th and11th grade students. Student-level Secondary Aims Secondary Aim 1: High school students in the intervention condition will decrease their rate of weight gain relative to height gain as measured by change in body mass index and percent body fat compared to students in the control condition. Hypothesis: Body mass index and percent body fat will be maintained or reduced in the treatment versus control group. Secondary Aim 2: High school students in the intervention condition will maintain or decrease their energy intake while improving dietary intakes of low fat dairy, whole grains and fresh fruits compared to the control students. Hypothesis: Energy intake (measured by 3, 24-hour recalls) will be maintained or reduced and intakes of low fat dairy, whole grains and fresh fruits will increase more in the intervention groups. Secondary Aim 3: Compared to students in the control condition, high school students in the intervention condition will report receiving more support to eat school breakfast. Support will be social (increased peer and school support) or related to the school environment (satisfaction with serving locations and times, eating locations, foods and increased availability of low fat dairy, fruits and whole grains for breakfast). Hypothesis: The treatment group will report receiving more social and school environment support for eating school breakfast than the comparison group (measured by a student survey).
Interventions
BEHAVIORALImprove 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Must be in 10th or 11th grade in school year 2013-14 Must have access to the internet Must have access to a phone
Exclusion criteria
for the Cohort: Unable to read English Unable to speak English Pregnant Plan to move out of the school district within school year Not in school most mornings Eat breakfast 4 or more days a week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Percent Students Eating the School Breakfast Per School | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Body Mass Index | Change from baseline (SY1) in student body mass index at the end of one school year (SY2). | Change from baseline to the end of one school year (SY2) in body mass index. |
| Change From Baseline in Percent Body Fat | Change from baseline in student body fat at the end of the school year (SY2) | Student percent body fat will be measured by trained research staff |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Healthy Eating Index Scores | Change from baseline in Healthy Eating Index at the end of the school year (SY2). | 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 |
| Social Support | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 463 |
| Comparison Arm the role of the comparison arm (schools) is to maintain usual breakfast program at school | 441 |
| Total | 904 |
Baseline characteristics
| Characteristic | Comparison Arm | Intervention Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 441 Participants | 463 Participants | 904 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 15.1 years STANDARD_DEVIATION 0.8 | 15.2 years STANDARD_DEVIATION 0.8 | 15.2 years STANDARD_DEVIATION 0.8 |
| Race/Ethnicity, Customized Asian | 10 Participants | 9 Participants | 19 Participants |
| Race/Ethnicity, Customized Black or African American | 16 Participants | 23 Participants | 39 Participants |
| Race/Ethnicity, Customized Mixed race | 77 Participants | 105 Participants | 182 Participants |
| Race/Ethnicity, Customized Native American or Alaska Native | 2 Participants | 21 Participants | 23 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 314 Participants | 283 Participants | 597 Participants |
| Region of Enrollment United States | 441 participants | 463 participants | 904 participants |
| Sex: Female, Male Female | 237 Participants | 254 Participants | 491 Participants |
| Sex: Female, Male Male | 204 Participants | 209 Participants | 413 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 463 | 0 / 441 |
| serious Total, serious adverse events | 0 / 463 | 0 / 441 |
Outcome results
Primary
Change From Baseline in Percent Students Eating the School Breakfast Per School
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)
Time frame: Change from baseline (SY1) in average school year school-level breakfast participation at the end of one school year (SY2).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Change From Baseline in Percent Students Eating the School Breakfast Per School | 8.3 % School Breakfast Participation | Standard Deviation 9.8 |
| Comparison Arm | Change From Baseline in Percent Students Eating the School Breakfast Per School | .9 % School Breakfast Participation | Standard Deviation 1.6 |
Secondary
Change From Baseline in Body Mass Index
Change from baseline to the end of one school year (SY2) in body mass index.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Change From Baseline in Body Mass Index | 1.0 kg/m^2 | Standard Deviation 1.8 |
| Comparison Arm | Change From Baseline in Body Mass Index | .9 kg/m^2 | Standard Deviation 1.6 |
Secondary
Change From Baseline in Percent Body Fat
Student percent body fat will be measured by trained research staff
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Change From Baseline in Percent Body Fat | .1 % Body Fat | Standard Deviation 4.3 |
| Comparison Arm | Change From Baseline in Percent Body Fat | -.2 % Body Fat | Standard Deviation 3.8 |
Other Pre-specified
Change From Baseline in Healthy Eating Index Scores
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Change From Baseline in Healthy Eating Index Scores | .6 Healthy Eating Index Total Score | Standard Deviation 15 |
| Comparison Arm | Change From Baseline in Healthy Eating Index Scores | -.3 Healthy Eating Index Total Score | Standard Deviation 12.9 |
Other Pre-specified
Social Support
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.
Time frame: Change in perceived support from baseline at the end of the school year (SY2)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Social Support | .3 scores on a scale | Standard Deviation 3.4 |
| Comparison Arm | Social Support | -.2 scores on a scale | Standard Deviation 3.9 |