- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02004977
Improving High School Breakfast Environments (breakFAST!)
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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).
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55414
- University of Minnesota
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Intervention arm
The role of the intervention arm (schools) is to improve access to the school breakfast program
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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.
Ostatní jména:
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Žádný zásah: Comparison arm
the role of the comparison arm (schools) is to maintain usual breakfast program at school
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change From Baseline in Percent Students Eating the School Breakfast Per School
Časové okno: Change from baseline (SY1) in average school year school-level breakfast participation at the end of one school year (SY2).
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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)
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Change from baseline (SY1) in average school year school-level breakfast participation at the end of one school year (SY2).
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in Body Mass Index
Časové okno: Change from baseline (SY1) in student body mass index at the end of one school year (SY2).
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Change from baseline to the end of one school year (SY2) in body mass index.
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Change from baseline (SY1) in student body mass index at the end of one school year (SY2).
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Change From Baseline in Percent Body Fat
Časové okno: Change from baseline in student body fat at the end of the school year (SY2)
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Student percent body fat will be measured by trained research staff
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Change from baseline in student body fat at the end of the school year (SY2)
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in Healthy Eating Index Scores
Časové okno: Change from baseline in Healthy Eating Index at the end of the school year (SY2).
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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
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Change from baseline in Healthy Eating Index at the end of the school year (SY2).
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Social Support
Časové okno: Change in perceived support from baseline at the end of the school year (SY2)
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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.
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Change in perceived support from baseline at the end of the school year (SY2)
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Marilyn S Nanney, PhD, University of Minnesota
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 1111S06384
- 1R01HL113235 (Grant/smlouva NIH USA)
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