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Effects of One Session Moderate-Intensity Aerobic Training and High-Intensity Interval Training on Food Craving- Food Choices- and Some Psychological Factors Related to Appetite Control in Overweight and Obese Women

Protocol summary

Study aim
Determining the effects of a session of moderate-intensity aerobic exercise and high-intensity interval training on craving, food choice, appetite, impulsivity, risk-taking decision-making, cognitive flexibility, and perceptual responses in overweight and obese women with cravings food
Design
Clinical trial, with control conditions, crossover, 15 participants, randomization will be done through Irandomization.com.
Settings and conduct
The present research will be conducted in the Faculty of Sports Sciences of Razi University of Kermanshah. Each participant will be exposed to three conditions of aerobic exercise, interval training or control condition in a random order.
Participants/Inclusion and exclusion criteria
Criteria for entering the research: age range from 18 to 40 years old, resident of Kermanshah city, body mass index (BMI) between 25 and 35 kg/m2, with food cravings (getting a total score of 108 or higher from the 15-item food craving questionnaire and 12-item visual analog questionnaire of craving for food), obtaining a certificate of non-prohibition of participation in the exercise program from the doctor - criteria for not entering the research: smoking, alcohol and various types of drugs, the presence of musculoskeletal abnormalities or disorders, participation in weight loss programs In the last 6 months, participating in a regular exercise program in the last 6 months
Intervention groups
A session of moderate intensity aerobic training, a session of high intensity interval training, a session of watching a 30-minute documentary film.
Main outcome variables
Food craving, food choice, appetite, impulsivity, risk-taking decision, cognitive flexibility, perceptual responses.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241020063435N1
Registration date: 2024-10-26, 1403/08/05
Registration timing: registered_while_recruiting

Last update: 2024-10-26, 1403/08/05
Update count: 0
Registration date
2024-10-26, 1403/08/05
Registrant information
Name
Chnour Ghaderi
Name of organization / entity
The Razi University of Kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 87 3459 0085
Email address
chnourghaderi77@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-26, 1403/08/05
Expected recruitment end date
2024-11-08, 1403/08/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of One Session Moderate-Intensity Aerobic Training and High-Intensity Interval Training on Food Craving- Food Choices- and Some Psychological Factors Related to Appetite Control in Overweight and Obese Women
Public title
Effects of a Session of Aerobic exercise with moderate-Intensity and intermittent exercise with high intensity on craving and appetite control in overweight and obese women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 18 to 40 years A resident of Kermanshah Body mass index (BMI) between 25 and 35 kg/m2 Having food cravings (getting a total score of 108 or higher from the 15-item food craving questionnaire and the 12-item visual analog food craving questionnaire) Obtaining a certificate of non-prohibition of participation in sports training program from the doctor
Exclusion criteria:
Smoking, alcohol and drugs Abnormalities or musculoskeletal disorders Participation in weight loss programs in the last 6 months Participating in a regular exercise program in the past 6 months
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the order of subject exposure to 3 different conditions (moderate intensity aerobic exercise, high intensity intermittent exercise and control condition) will be randomized by Latin square method. For this purpose, first, using the website www.random.org, each subject will be randomly assigned a number between 1 and 15 as an identification code. Then, the English letters A.B.C will be assigned to the three intervention conditions and a Latin square with three rows and three columns will be created. Finally, participants number 1 to 5 are placed in the sequence of the first row, participants number 6 to 10 are placed in the sequence of the second row, and participants number 11 to 15 are placed in the sequence of the third row.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Razi University
Street address
Taq Bostan, University Street, Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2024-07-03, 1403/04/13
Ethics committee reference number
IR.RAZI.REC.1403.017

Health conditions studied

1

Description of health condition studied
overweight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
Food cravings
Timepoint
24 and 48 hours after completing the interventions
Method of measurement
15-item food craving questionnaire and 12-item visual analogue food craving questionnaire

2

Description
Food preference
Timepoint
Before and after the interventions
Method of measurement
Online food preference questionnaire software

3

Description
appetite
Timepoint
1, 2, 4, 24 and 48 hours after the intervention
Method of measurement
Visual analogue subjective scale of appetite

Secondary outcomes

1

Description
impulsiveness
Timepoint
Before and after the interventions
Method of measurement
Go/no go cognitive test software

2

Description
Risky decision making
Timepoint
Before and after the interventions
Method of measurement
Iowa gambling cognitive test software

3

Description
Cognitive flexibility
Timepoint
Before and after the interventions
Method of measurement
20-question cognitive flexibility questionnaire

4

Description
sense of pleasure
Timepoint
Before and after the interventions
Method of measurement
11-item emotion scale

5

Description
Arousal level
Timepoint
Before and after the interventions
Method of measurement
6-point scale of perceived arousal

Intervention groups

1

Description
Intervention group: In this research, all the subjects will be exposed to two intervention conditions with an interval of at least 7 days, including 1- aerobic exercise with moderate intensity, 2- intermittent exercise with high intensity.
Category
Treatment - Devices

2

Description
Control group: In this study, all the subjects will watch a documentary film for 30 minutes that does not have any spiritual, psychological, emotional or motivational effects.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi University of Kermanshah
Full name of responsible person
Amir Abbas Monazzami
Street address
Taq Bostan, University Blvd., Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
monazzami.amirabbas@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Dr. Mostafa Mostafaei
Street address
Taq Bostan, University Street, Razi University
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4515
Email
b.mostafaei@razi.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi University of Kermanshah
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Amir Abbas Monazzami
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Taq Bostan, University Street, Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
monazzami.amirabbas@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Amir Abbas Monazzami
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Taq Bostan, University Street, Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
monazzami.amirabbas@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Amir Abbas Monazzami
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Taq Bostan, University Street, Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
monazzami.amirabbas@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after de-identifying subjects.
When the data will become available and for how long
6-9 months after printing the results
To whom data/document is available
Supervisor and executive researcher
Under which criteria data/document could be used
Meta-analysis research
From where data/document is obtainable
Take action by sending an e-mail to Amirabbas Monazzami, supervisor, at monazzami.amirabbas@gmail.com and Chnour Ghaderi, researcher, at chnourghaderi77@gmail.com.
What processes are involved for a request to access data/document
In case of an official request, the relevant reasons are announced and full details are mentioned, the data will be sent via email after 72 hours.
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