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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL113235 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | The role of the intervention arm (schools) is to improve access to the school breakfast program |
|
| Comparison arm | No Intervention | the role of the comparison arm (schools) is to maintain usual breakfast program at school |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Improve access to the school breakfast program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Change from baseline (SY1) in average school year school-level breakfast participation at the end of one school year (SY2). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Mass Index | Change from baseline to the end of one school year (SY2) in body mass index. | Change from baseline (SY1) in student body mass index at the end of one school year (SY2). |
| Change From Baseline in Percent Body Fat |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from baseline in Healthy Eating Index at the end of the school year (SY2). |
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
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| Name | Affiliation | Role |
|---|---|---|
| Marilyn S Nanney, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30772298 | Derived | Nanney MS, Leduc R, Hearst M, Shanafelt A, Wang Q, Schroeder M, Grannon KY, Kubik MY, Caspi C, Harnack LJ. A Group Randomized Intervention Trial Increases Participation in the School Breakfast Program in 16 Rural High Schools in Minnesota. J Acad Nutr Diet. 2019 Jun;119(6):915-922. doi: 10.1016/j.jand.2018.12.007. Epub 2019 Feb 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Comparison Arm | the role of the comparison arm (schools) is to maintain usual breakfast program at school |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | % School Breakfast Participation | Change from baseline (SY1) in average school year school-level breakfast participation at the end of one school year (SY2). | Schools | Schools |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susie Nanney | University of Minnesota | 612-626-6794 | msnanney@umn.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
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Student percent body fat will be measured by trained research staff |
| Change from baseline in student body fat at the end of the school year (SY2) |
| 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. | Change in perceived support from baseline at the end of the school year (SY2) |
| BG001 | Comparison Arm | the role of the comparison arm (schools) is to maintain usual breakfast program at school |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 |
| Comparison Arm |
the role of the comparison arm (schools) is to maintain usual breakfast program at school |
|
|
| Secondary | Change From Baseline in Body Mass Index | Change from baseline to the end of one school year (SY2) in body mass index. | 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. | Posted | Mean | Standard Deviation | kg/m^2 | Change from baseline (SY1) in student body mass index at the end of one school year (SY2). |
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| Secondary | Change From Baseline in Percent Body Fat | Student percent body fat will be measured by trained research staff | 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. | Posted | Mean | Standard Deviation | % Body Fat | Change from baseline in student body fat at the end of the school year (SY2) |
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| 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 | 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. | Posted | Mean | Standard Deviation | Healthy Eating Index Total Score | Change from baseline in Healthy Eating Index at the end of the school year (SY2). |
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|
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| 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. | Posted | Mean | Standard Deviation | scores on a scale | Change in perceived support from baseline at the end of the school year (SY2) |
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| 0 |
| 463 |
| 0 |
| 463 |
| EG001 | Comparison Arm | the role of the comparison arm (schools) is to maintain usual breakfast program at school | 0 | 441 | 0 | 441 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |