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Stress and Eating Behavior Among University Students - an Randomized Controlled Trial (StrEat)

2016년 3월 14일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (예상)

50

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Frederiksberg, 덴마크, 1958
        • 모병
        • Nutrition, Exercise and Sports
        • 연락하다:
        • 연락하다:
          • Julie B Schmidt, PhD
          • 전화번호: 0045 35333650
          • 이메일: jbs@nexs.ku.dk

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
This visit takes place one week prior to an exam at the university assuming that students will be stressed in this period.
위약 비교기: 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)
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Differences in purchase of high reward foods from the gift certificates between the exam-period and non-exam period.
기간: 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 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Differences in Heart Rate Variability (HRV) based on a one minute breathing test between the exam-period and non-exam period.
기간: 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 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)
Differences in morning cortisol measured in saliva between the exam-period and non-exam period.
기간: 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 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)
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.
기간: 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)
Differences in Perceived Stress (Perceived Stress Scale, PSS) between the exam-period and non-exam period.
기간: 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)
Differences in eating behavior using the "Three factor eating questionnaire" between the exam-period and non-exam period.
기간: 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)
Differences in sleep habits using the "Pittsburgh sleep quality index" between the exam-period and non-exam period.
기간: 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)
Differences in sleep duration measured by ActiGraph between the exam-period and non-exam period.
기간: 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.
기간: 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 blood pressure between the exam-period and non-exam period.
기간: 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)
Differences in Perceived Stress ( questionaire: RESTQ-76 sport) between the exam-period and non-exam period.
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 의자: Anders M Sjödin, PhD, University of Copenhagen, NEXS
  • 수석 연구원: Mads F Hjorth, PhD, University of Copenhagen
  • 수석 연구원: Julie B Schmidt, PhD, University of Copenhagen, NEXS

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2016년 2월 1일

기본 완료 (예상)

2016년 8월 1일

연구 완료 (예상)

2016년 8월 1일

연구 등록 날짜

최초 제출

2016년 3월 4일

QC 기준을 충족하는 최초 제출

2016년 3월 14일

처음 게시됨 (추정)

2016년 3월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 3월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 3월 14일

마지막으로 확인됨

2016년 3월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • B321

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