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

StrEat - Stress and Eating Behavior

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02708979
Acronym
StrEat
Enrollment
50
Registered
2016-03-15
Start date
2016-02-29
Completion date
2016-08-31
Last updated
2016-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress

Keywords

Stress, Eating

Brief 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. 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.

Interventions

OTHERUniversity exam-period

This visit takes place one week prior to an exam at the university assuming that students will be stressed in this period.

OTHERUniversity 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.

Sponsors

University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Differences in purchase of high reward foods from the gift certificates between the exam-period and non-exam period.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.

Secondary

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

Countries

Denmark

Contacts

Primary ContactMads F Hjorth, PhD
madsfiil@nexs.ku.dk35332489
Backup ContactJulie B Schmidt, PhD
jbs@nexs.ku.dk35333650

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026