The Efficacy of Proper Breakfast Times on Cognitive Function

August 6, 2024 updated by: Riza Septiani, University of Muhammadiyah Aceh

The Effectiveness of Proper Breakfast Times on Cognitive Function and Health Outcomes Among College Students

The goal of this cluster randomized controlled trial is to learn if a proper breakfast time may increase cognitive function. It will also learn about the effectiveness of proper breakfast time on health outcomes. The main questions it aims to answer are:

Does a proper breakfast time increase cognitive function and health outcomes?

Participants will:

  • wake up in the morning at 6 o'clock
  • Having breakfast at 6.30 - 7.30 am or 7.31-8.31 am, or having breakfast time according to their wishes.
  • Having lunch started at 12.00 pm.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This experimental study uses a Cluster Randomized Controlled Trial non-blinding parallel method design. The objective of this study is to assess the effectiveness of proper breakfast time on cognitive function including the focus on learning and mood among university students. Additionally, the study determines health outcomes such as heart rate, systolic blood pressure, diastolic blood pressure, and macro and micronutrient intake. There are a total of 60 participants from three different faculties. All faculties will be randomly selected and assigned to intervention group 1, intervention group 2, and the control group. Each group consists of 20 participants from each faculty in the university. Intervention Group 1 will have breakfast from 6:30 to 7:30 am, and Intervention Group 2 from 7:31 to 8:31 am. Meanwhile, the control group will continue their preferred breakfast routine. The intervention groups are required to wake up at 6:00 am and have lunch at 12:00 pm.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Active student in the year 2024
  • Not in medication
  • Do not have gastritis or any diseases that require to have breakfast earlier in the morning
  • Willing to sign an informed consent
  • Have health insurance

Exclusion Criteria:

  • Abstain in the education session
  • Having emotional and mental health problems
  • Students in the final class who are undergoing the thesis writing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breakfast1
This group will have breakfast time at 6.30 to 7.30 am
Other: breakfast 6.30 am
This group will have breakfast time from 6.30 to 7.30 am
Experimental: Breakfast2
This group will have breakfast time from 7.31 am to 8.31 am
Other: breakfast 7.31 am
This group will have breakfast time from 7.31 to 8.31 am
No Intervention: Control
This group will have breakfast time according to their wishes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Focus
Time Frame: 8 weeks
To determine the changes in focus between the groups using the Army alpha test
8 weeks
Mood
Time Frame: 8 weeks
To determine the changes in mood between the groups using the profile of moods state (POMS) questionnaire
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: 8 weeks
To determine the changes in systolic blood pressure between the groups using the sphygmomanometer
8 weeks
Diastolic blood pressure
Time Frame: 8 weeks
To determine the changes in diastolic blood pressure between the groups using the sphygmomanometer
8 weeks
Heart rate
Time Frame: 8 weeks
To determine the changes in heart rate between the groups using the sphygmomanometer
8 weeks
macro nutrition intake
Time Frame: 8 weeks
To determine the changes in macro nutrition intake between the groups using the 3-day food record
8 weeks
micro-nutrition
Time Frame: 8 weeks
To determine the changes in micro-nutrition intake between the groups using the 3-day food record
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Muhammadiyah Aceh

Investigators

  • Principal Investigator: Riza Septiani, Ph.D, University of Muhammadiyah Aceh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • LP4MRiset

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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