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

2016年3月14日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (予想される)

50

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Frederiksberg、デンマーク、1958
        • 募集
        • Nutrition, Exercise and Sports
        • コンタクト:
        • コンタクト:
          • Julie B Schmidt, PhD
          • 電話番号:0045 35333650
          • メールjbs@nexs.ku.dk

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:基礎科学
  • 割り当て:ランダム化
  • 介入モデル:クロスオーバー割り当て
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ: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.
プラセボコンパレーター: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Differences in purchase of high reward foods from the gift certificates between the exam-period and non-exam period.
時間枠: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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Differences in Heart Rate Variability (HRV) based on a one minute breathing test between the exam-period and non-exam period.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディチェア:Anders M Sjödin, PhD、University of Copenhagen, NEXS
  • 主任研究者:Mads F Hjorth, PhD、University of Copenhagen
  • 主任研究者:Julie B Schmidt, PhD、University of Copenhagen, NEXS

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2016年2月1日

一次修了 (予想される)

2016年8月1日

研究の完了 (予想される)

2016年8月1日

試験登録日

最初に提出

2016年3月4日

QC基準を満たした最初の提出物

2016年3月14日

最初の投稿 (見積もり)

2016年3月15日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年3月15日

QC基準を満たした最後の更新が送信されました

2016年3月14日

最終確認日

2016年3月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • B321

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

University exam-periodの臨床試験

3
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