Stress and Eating Behavior Among University Students - an Randomized Controlled Trial
NCT ID: NCT02708979
Last Updated: 2016-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2016-02-29
2016-08-31
Brief Summary
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Our aim is to investigate differences in purchases of particular food-items in free living individuals, during a stressful (upcoming exam) and non-stressful (no upcoming exam) period.
Hypothesis: Participants will purchase more high reward foods during the pre-exam period, compared to the control non-exam period.
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Detailed Description
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Study design:
The study is a randomized controlled two-armed cross-over intervention study. The study is carried out in 50 healthy university students, both genders. In random order the participants will be investigated during stressful-period (prior to an exam) and a non-stressful (control period) period. Each participant will take part in all together four visits, two in the stressful period and two visits in the non-stressful period.
The study will take place, at the Department of Nutrition, Exercise and Sports (NEXS), Faculty of Science at the University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C. Recruitment will take place at the University of Copenhagen
STATISTICAL ANALYSES Analysis of the primary outcome (food choices) will be based on an ANCOVA-type linear mixed model with the intervention and allocation order as the fixed effect and person as the random effect. Analysis will be performed using the software R, SAS, STATA or SPSS. Analyses, data processing and writing of the article are expected to extend over the study period and a year beyond.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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University Exam Period
This visit takes place the week before an exam at the university assuming that this will induce a stress response. Measurements (see description elsewhere) are being taken within 1-2 weeks prior to an university exam.
University exam-period
This visit takes place one week prior to an exam at the university assuming that students will be stressed in this period.
University Non-exam Period
This visit takes place several weeks post and prior to an exam at the university assuming that students will not be stressed in this period. Measurements (see description elsewhere) are being taken in a control-period without exams (at least 4 weeks after and 4 weeks prior to an exam)
University non-exam-period
This visit takes place several weeks post and prior to an exam at the university assuming that students will not be stressed in this period.
Interventions
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University exam-period
This visit takes place one week prior to an exam at the university assuming that students will be stressed in this period.
University non-exam-period
This visit takes place several weeks post and prior to an exam at the university assuming that students will not be stressed in this period.
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years, men and women
Exclusion Criteria
* Diabetes.
* Blood donation \< 1 week prior to the study and during the study
* Lactation, Pregnancy or planning of pregnancy during the study
* Inability, physically or mentally, to comply with the procedures required by the study- protocol, as evaluated by the investigator
* Participation in other clinical trials during the study
* Diagnosed with stress
* Daily use of medication influencing biomarkers of stress
ALL
Yes
Sponsors
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University of Copenhagen
OTHER
Responsible Party
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Anders M Sjödin, MD, PhD, Professor
Professor
Principal Investigators
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Anders M Sjödin, PhD
Role: STUDY_CHAIR
University of Copenhagen, NEXS
Mads F Hjorth, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Julie B Schmidt, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen, NEXS
Locations
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Nutrition, Exercise and Sports
Frederiksberg, Frederiksberg, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B321
Identifier Type: -
Identifier Source: org_study_id
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