StressStrEatNCT02708979
Stress and Eating Behavior Among University Students - an Randomized Controlled Trial
A study testing University exam-period and University non-exam-period in people with Stress, run by University of Copenhagen at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- University exam-period and University non-exam-period
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Nutrition, Exercise and Sports
Frederiksberg, Frederiksberg, 1958
Mads F Hjorth, PhD, 35332489 ext. 0045, madsfiil@nexs.ku.dk
Julie B Schmidt, PhD, 35333650 ext. 0045, jbs@nexs.ku.dk
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Stress
- Being tested
- University exam-period, University non-exam-period
- Keywords
- Stress, Eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
University exam-periodOther
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-periodOther
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.
| Study group | Role | What they receive |
|---|---|---|
| University Exam Period | Active comparator | 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. Receives: Other: University exam-period |
| University Non-exam Period | Placebo comparator | 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) Receives: Other: University non-exam-period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in purchase of high reward foods from the gift certificates between the exam-period and non-exam period.
The classification will be done blinded for the outcome assessor.
Measured: 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)
Secondary outcomes (10)
Differences in Heart Rate Variability (HRV) based on a one minute breathing test between the exam-period and non-exam period.
The classification will be done blinded for the outcome assessor.
Measured: 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.
The classification will be done blinded for the outcome assessor.
Measured: 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.
The analyses will be done blinded for the outcome assessor.
Measured: 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.
The analyses will be done blinded for the outcome assessor.
Measured: 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.
The analyses will be done blinded for the outcome assessor.
Measured: 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.
The analyses will be done blinded for the outcome assessor.
Measured: 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.
The analyses will be done blinded for the outcome assessor.
Measured: 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.
The analyses will be done blinded for the outcome assessor.
Measured: 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.
The analyses will be done blinded for the outcome assessor.
Measured: 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.
The analyses will be done blinded for the outcome assessor.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders M Sjödin, MD, PhD, Professor, University of Copenhagen
- Investigators
- Anders M Sjödin, PhD, Study chair, University of Copenhagen, NEXSMads F Hjorth, PhD, Principal investigator, University of CopenhagenJulie B Schmidt, PhD, Principal investigator, University of Copenhagen, NEXS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708979
- Sponsor's protocol ID
- B321
- Acronym
- StrEat
- Status last verified
- Mar 2016
- First submitted
- 4 Mar 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StrEat - Stress and Eating Behavior
- ClinicalTrials.gov ID
- NCT02708979
- Acronym / sponsor ID
- StrEat / B321
- Conditions
- Stress
- Keywords
- Stress, Eating
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| University Exam Period | Active comparator | Other: University exam-periodThis 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 Non-exam Period | Placebo comparator | Other: University non-exam-periodThis 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| University exam-periodThis visit takes place one week prior to an exam at the university assuming that students will be stressed in this period. | Other | University Exam Period |
| University non-exam-periodThis visit takes place several weeks post and prior to an exam at the university assuming that students will not be stressed in this period. | Other | University Non-exam Period |
Primary outcome
Differences in purchase of high reward foods from the gift certificates between the exam-period and non-exam period.
Time frame: 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.
10 secondary outcomes
Differences in Heart Rate Variability (HRV) based on a one minute breathing test between the exam-period and non-exam period.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders M Sjödin, PhD study chair
University of Copenhagen, NEXS
Mads F Hjorth, PhD principal investigator
University of Copenhagen
Julie B Schmidt, PhD principal investigator
University of Copenhagen, NEXS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing University exam-period and University non-exam-period in people with Stress, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mads F Hjorth, PhD (35332489 ext. 0045, madsfiil@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in purchase of high reward foods from the gift certificates between the exam-period and non-exam period. (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2016.