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The Effects of gain-versus-loss messages following adherence to the Dietary Approaches to Stop Hypertension (DASH) diet and a low-glycemic index diet on stress, anxiety, depression and fatigue in multiple sclerosis patients: a randomized controlled clinical trial

Protocol summary

Study aim
Investigating the effects of gain-versus-loss messages following the DASH diet and low-glycemic index diet on stress, anxiety, depression, and fatigue in people with multiple sclerosis:a randomized controlled clinical trial
Design
Open-label, parallel controlled randomized trial
Settings and conduct
Multiple sclerosis diagnosed by a neurologist from Ahvaz MS Association, divided into 3 groups of 32, receives Gain-loss framed messages (DASH and low glycemic index diet ). control receive routine care, for 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having multiple sclerosis, the age range of 18 to 55 years, willing to participate in the study (filling in the informed consent form), stable in disease-modifying treatment for 6 months, no relapse in the last 30 days, reliable access through Computer or smartphone to the Internet, Extended Disability Status Scale (EDSS) less than 4.5, literate people Exclusion criteria: Suffering from other types of multiple sclerosis, suffering from any other neurological disease, Suffering from various malignancies, other autoimmune and infectious diseases, kidney and liver diseases, metabolic disorders, using insulin to control diabetes, menopause, in the previous 5 years, if simultaneously participating in another study, illiterate or unwilling to read, Unwillingness to continue participating in the study
Intervention groups
Patients are randomly divided into three groups of 32 people who receive health messages of gain and loss and a control group receives a routine health program. In this study, gain-framed and loss-framed health messages are given to two groups of intervention respectively for 12 weeks.
Main outcome variables
Fatigue

General information

Reason for update
Acronym
Dietary Approaches to Stop Hypertension (DASH)
IRCT registration information
IRCT registration number: IRCT20220902055853N3
Registration date: 2023-10-21, 1402/07/29
Registration timing: registered_while_recruiting

Last update: 2023-10-21, 1402/07/29
Update count: 0
Registration date
2023-10-21, 1402/07/29
Registrant information
Name
fatemeh borazjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3321 9570
Email address
fa.borazjani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-11, 1402/06/20
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of gain-versus-loss messages following adherence to the Dietary Approaches to Stop Hypertension (DASH) diet and a low-glycemic index diet on stress, anxiety, depression and fatigue in multiple sclerosis patients: a randomized controlled clinical trial
Public title
The Effects of gain versus loss messages following adherence to the DASH diet and a low glycemic index diet in multiple sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having multiple sclerosis Age range of 18 to 55 years Stable in disease-modifying treatment for 6 months No relapse in the last 30 days Willing to participate in project (filling informed consent form) Access through Computer or smartphone to the Internet Extended Disability Status Scale (EDSS) less than 4.5 Literate people
Exclusion criteria:
Suffering from other types of multiple sclerosis, , if ,, , in the study Suffering from any other neurological disease Simultaneously participating in another study Taking insulin , menopause, history of kidney stones in the last 5 years Illiterate or unwilling to read Unwillingness to continue participation
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
The entry of each patient into three different groups (receivers of gain-framed and Loss-Framed Messages, and control) is randomly divided based on permuted block randomization (with blocks of 3) using Random Allocation Software (RAS).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Open label, Parallel - controlled randomized trial

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Ahvaz Jundishapur university of medical sciences,Ahvaz,Iran.
Street address
Academic Town , Ahvaz , Ahvaz University of Medical Sciences and Health Care Services , Research and Technology Development Vice Chancellor Building
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-06-17, 1402/03/27
Ethics committee reference number
IR.AJUMS.REC.1402.165

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Fatigue
Timepoint
At the beginning and end of study
Method of measurement
Using Modified Fatigue Impact Scale (MFIS) questionnaire

Secondary outcomes

1

Description
Stress
Timepoint
At the begin and end of study
Method of measurement
Using the Depression Anxiety Stress Scale-21 Items (DASS-21) questionnaire

2

Description
Anxiety
Timepoint
At the begin and end of study
Method of measurement
Using the Depression Anxiety Stress Scale-21 Items (DASS-21) questionnaire

3

Description
Depression
Timepoint
At the begin and end of study
Method of measurement
Using the Depression Anxiety Stress Scale-21 Items (DASS-21) questionnaire

4

Description
Physical Activity
Timepoint
At the begin and end of study
Method of measurement
Short form of the International Physical Activity Questionnaire (IPAQ-SF)

5

Description
Dietary intake (Energy, Carbohydrate, Fat, Protein)
Timepoint
At the begin and end of study
Method of measurement
Using Nutritionist IV software

6

Description
intensity of pain
Timepoint
At the begin and end of study
Method of measurement
using the visual analog scale (VAS) questionnaire

Intervention groups

1

Description
Intervention group 1: The gain-framed health messages refer to a DASH diet and low glycemic index with a positive capacity for 12 weeks.
Category
Prevention

2

Description
Intervention group2: The loss-framed health messages refer to a DASH diet and low glycemic index with a negative capacity for 12 weeks.
Category
Prevention

3

Description
Control group: Receive routine health care within 12 weeks
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
MS association of Ahvaz city
Full name of responsible person
Faezeh Moeini Badi
Street address
Golestan Medical Sciences Dormitory, Golestan Boulevard, Ahvaz, Khouzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 912 639 9027
Email
moeinibadifaezeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Ahvaz Jundishapur University of Medical Sciences, Research and Technology Vice-Chancellor Address: Ahvaz Jundishapur Medical Sciences University, Research and Technology Vice Chancellor, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
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
Ahvaz University of Medical Sciences
Full name of responsible person
Faezeh Moeini Badi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Medical Sciences Dormitory , Golestan Boulevard , Ahvaz , Khouzestan , Iran
City
َAhvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3336 2414
Email
moeinibadifaezeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Borazjani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Jundishapur university of medical sciences , university campus , golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3321 9570
Fax
Email
fa.borazjani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Faezeh Moeini Badi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Medical Sciences Dormitory, Golestan Boulevard , Ahvaz , Khouzestan , Iran
City
َAhvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3336 2414
Email
moeinibadifaezeh@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
The Effects of gain-framed versus loss-framed messages following adherence to the Dietary Approaches to Stop Hypertension (DASH) diet and a low-glycemic index diet on stress, anxiety, depression and fatigue in multiple sclerosis patients: a randomized controlled clinical trial
When the data will become available and for how long
After the publication of the article
To whom data/document is available
All
Under which criteria data/document could be used
Study
From where data/document is obtainable
Fatemeh Borazjani
What processes are involved for a request to access data/document
E -mail
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