Stress and Eating Behavior Among University Students - an Randomized Controlled Trial (StrEat)
14. března 2016 aktualizováno: Anders M Sjödin, MD, PhD, Professor, University of Copenhagen
StrEat - Stress and Eating Behavior
The high worldwide prevalence of overweight and obesity as well as metabolic and disease consequences, are well-documented. The positive energy balance underlying obesity is attributable to excess energy intake and/or insufficient energy expenditure. However, it seems that the increase in mean body weight can be sufficiently explained by increases in mean energy intake. It has been proposed that this overeating is partly caused by increased availability of highly processed energy dense, high reward foods. Psychosocial stress and sleep insufficiency is pervasive in industrialized societies. A growing body of evidence suggests stress to be involved in obesity, although it is unknown whether stress is a cause or consequence. Stress affecting dietary intake; skewing intake towards greater consumption of highly palatable energy dense foods, also referred to as high reward foods. A causal relationship between stress and reward seeking behavior is supported by findings from animal studies reporting rewarding behavior by consumption of sweet tasting food in response to a stressor.
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.
Přehled studie
Postavení
Neznámý
Podmínky
Intervence / Léčba
Detailní popis
STUDY METHODS
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.
Typ studie
Intervenční
Zápis (Očekávaný)
50
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Frederiksberg, Dánsko, 1958
- Nábor
- Nutrition, Exercise and Sports
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Kontakt:
- Mads F Hjorth, PhD
- Telefonní číslo: 0045 35332489
- E-mail: madsfiil@nexs.ku.dk
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Kontakt:
- Julie B Schmidt, PhD
- Telefonní číslo: 0045 35333650
- E-mail: jbs@nexs.ku.dk
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Healthy, weight stabile (defined as no weight gain/loss >3 kg during the past three months) students at the University of Copenhagen
- Age > 18 years, men and women
Exclusion Criteria:
- Purposefully seeking to lose or gain weight
- 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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: 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.
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This visit takes place one week prior to an exam at the university assuming that students will be stressed in this period.
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Komparátor placeba: 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)
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Differences in purchase of high reward foods from the gift certificates between the exam-period and non-exam period.
Časové okno: The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
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The classification will be done blinded for the outcome assessor.
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The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Differences in Heart Rate Variability (HRV) based on a one minute breathing test between the exam-period and non-exam period.
Časové okno: The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
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The classification will be done blinded for the outcome assessor.
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The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
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Differences in morning cortisol measured in saliva between the exam-period and non-exam period.
Časové okno: The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
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The classification will be done blinded for the outcome assessor.
|
The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
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Differences in insulin resistance measured by homeostatic model assessment (HOMA-IR) calculated from insulin and glucose measured in plasma between the exam-period and non-exam period.
Časové okno: The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
|
The analyses will be done blinded for the outcome assessor.
|
The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
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Differences in Perceived Stress (Perceived Stress Scale, PSS) between the exam-period and non-exam period.
Časové okno: The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
|
The analyses will be done blinded for the outcome assessor.
|
The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
|
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Differences in eating behavior using the "Three factor eating questionnaire" between the exam-period and non-exam period.
Časové okno: The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
|
The analyses will be done blinded for the outcome assessor.
|
The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
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Differences in sleep habits using the "Pittsburgh sleep quality index" between the exam-period and non-exam period.
Časové okno: The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
|
The analyses will be done blinded for the outcome assessor.
|
The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
|
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Differences in sleep duration measured by ActiGraph between the exam-period and non-exam period.
Časové okno: The outcome is assessed twice, in the exam period (one week prior to an exam) and in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
|
The analyses will be done blinded for the outcome assessor.
|
The outcome is assessed twice, in the exam period (one week prior to an exam) and in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
|
|
Differences in activity measured by ActiGraph between the exam-period and non-exam period.
Časové okno: The outcome is assessed twice,in the exam period (one week prior to an exam) and in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
|
The analyses will be done blinded for the outcome assessor.
|
The outcome is assessed twice,in the exam period (one week prior to an exam) and in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
|
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Differences in blood pressure between the exam-period and non-exam period.
Časové okno: The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
|
The analyses will be done blinded for the outcome assessor.
|
The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
|
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Differences in Perceived Stress ( questionaire: RESTQ-76 sport) between the exam-period and non-exam period.
Časové okno: The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
|
The analyses will be done blinded for the outcome assessor.
|
The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Studijní židle: Anders M Sjödin, PhD, University of Copenhagen, NEXS
- Vrchní vyšetřovatel: Mads F Hjorth, PhD, University of Copenhagen
- Vrchní vyšetřovatel: Julie B Schmidt, PhD, University of Copenhagen, NEXS
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. února 2016
Primární dokončení (Očekávaný)
1. srpna 2016
Dokončení studie (Očekávaný)
1. srpna 2016
Termíny zápisu do studia
První předloženo
4. března 2016
První předloženo, které splnilo kritéria kontroly kvality
14. března 2016
První zveřejněno (Odhad)
15. března 2016
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
15. března 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
14. března 2016
Naposledy ověřeno
1. března 2016
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- B321
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ne
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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