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

University of Copenhagen

Status: Unknown

Conditions: Stress

Treatments: Other: University exam-period; Other: University non-exam-period

Study type: Interventional

Funder types: Other

Identifiers

NCT02708979

B321

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

50 participants in 2 patient groups, including a placebo group

University Exam Period

Active Comparator group

Description:

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.

Treatment:

Other: University exam-period

University Non-exam Period

Placebo Comparator group

Description:

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)

Treatment:

Other: University non-exam-period