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

NCT ID: NCT02708979

Last Updated: 2016-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

University exam-period

Intervention Type OTHER

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 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)

Group Type PLACEBO_COMPARATOR

University non-exam-period

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

University exam-period

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anders M Sjödin, MD, PhD, Professor

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anders M Sjödin, PhD

Role: STUDY_CHAIR

University of Copenhagen, NEXS

Mads F Hjorth, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Julie B Schmidt, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen, NEXS

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nutrition, Exercise and Sports

Frederiksberg, Frederiksberg, Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mads F Hjorth, PhD

Role: CONTACT

35332489 ext. 0045

Julie B Schmidt, PhD

Role: CONTACT

35333650 ext. 0045

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mads F Hjorth, PhD

Role: primary

35332489 ext. 0045

Julie B Schmidt, PhD

Role: backup

35333650 ext. 0045

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B321

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Young Adult Eating Habits
NCT05550818 COMPLETED NA
Food Genetics Behavior Study
NCT05783765 RECRUITING NA