- ICH GCP
- US-Register für klinische Studien
- Klinische 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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).
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Minnesota
-
Minneapolis, Minnesota, Vereinigte Staaten, 55414
- University of Minnesota
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Intervention arm
The role of the intervention arm (schools) is to 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.
Andere Namen:
|
Kein Eingriff: Comparison arm
the role of the comparison arm (schools) is to maintain usual breakfast program at school
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change From Baseline in Percent Students Eating the School Breakfast Per School
Zeitfenster: 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)
|
Change from baseline (SY1) in average school year school-level breakfast participation at the end of one school year (SY2).
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change From Baseline in Body Mass Index
Zeitfenster: 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 (SY1) in student body mass index at the end of one school year (SY2).
|
Change From Baseline in Percent Body Fat
Zeitfenster: 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
|
Change from baseline in student body fat at the end of the school year (SY2)
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change From Baseline in Healthy Eating Index Scores
Zeitfenster: 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
|
Change from baseline in Healthy Eating Index at the end of the school year (SY2).
|
Social Support
Zeitfenster: 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.
|
Change in perceived support from baseline at the end of the school year (SY2)
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Marilyn S Nanney, PhD, University of Minnesota
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 1111S06384
- 1R01HL113235 (US NIH Stipendium/Vertrag)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .