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The effect of lifestyle modification treatment and dietary change on the quality of life, severity of gastrointestinal symptom and the level of anxiety, and depression in patients with irritable bowel syndrome

Protocol summary

Study aim
Determining the effect of therapeutic intervention of lifestyle modification and dietary change on the quality of life and anxiety and depression in patients with irritable bowel syndrome
Design
A clinical trial, before and after comparison, without a control group, an intervention group with a sample size of 55 patients by available sampling method, phase 2, unblinded. Randomization does not apply at this study
Settings and conduct
Before and after study in the field of psychiatry and gastroenterology. 55 patients with irritable bowel syndrome, male and female, aged 15 to 65 years in the gastrointestinal clinic of Taleghani Hospital in Tehran, with available sampling and obtaining consent. First, patients completed the Beck Anxiety and Depression Standard Questionnaire, the Irritable Bowel Syndrome Symptoms Severity Questionnaire, and the Quality of Life Questionnaire. After training by a nutritionist and psychologist and performing two months of lifestyle and diet modification intervention, the above questionnaires were completed again.Blindness does not apply at this study
Participants/Inclusion and exclusion criteria
Patients with IBS who consent to participate in the scheme. Patients who do not follow the therapeutic intervention or are treated for psychiatric disorders will be excluded from the study.
Intervention groups
IBS patients After an initial evaluation with standard questionnaires for quality of life, anxiety, depression, and IBS symptoms severity, Lifestyle modification intervention was performed. (Interventions include adequate physical activity training as 150 minutes per week, medium speed walking, no smoking and alcohol, and low FODMAP diet). After the intervention period of 2 months, patients were re-evaluated with the above questionnaires.
Main outcome variables
Severity of gastrointestinal symptoms, quality of life, anxiety and depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220329054367N1
Registration date: 2022-04-25, 1401/02/05
Registration timing: retrospective

Last update: 2022-04-25, 1401/02/05
Update count: 0
Registration date
2022-04-25, 1401/02/05
Registrant information
Name
Seyed Shahab Banihashem
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2540
Email address
shb_banihashem@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
2018-06-05, 1397/03/15
Actual recruitment end date
2020-09-22, 1399/07/01
Trial completion date
2020-11-21, 1399/09/01
Scientific title
The effect of lifestyle modification treatment and dietary change on the quality of life, severity of gastrointestinal symptom and the level of anxiety, and depression in patients with irritable bowel syndrome
Public title
The effect of lifestyle and diet modification on psychological symptoms in patients with irritable bowel syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Has IBS diagnosis based on ROM IV criteria Satisfaction with participation in the project
Exclusion criteria:
Patients receiving therapy due to underlying psychiatric problem
Age
From 15 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 55
Actual sample size reached: 55
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Approval date
2018-03-21, 1397/01/01
Ethics committee reference number
IR.sbmu.msp.rec.1397.333

Health conditions studied

1

Description of health condition studied
Irritable bowel syndrome (IBS)
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome

Primary outcomes

1

Description
Severity of gastrointestinal symptoms in irritable bowel severity scoring system-questionnaire (primary outcome)
Timepoint
Before starting the intervention and 2 months after the intervention
Method of measurement
irritable bowel severity scoring system-questionnaire

2

Description
quality of life score in quality of life -IBS questionnaire (primary outcome)
Timepoint
Before starting the intervention and 2 months after the intervention
Method of measurement
quality of life -IBS questionnaire

3

Description
Depression severity score in Beck Depression Inventory (primary outcome)
Timepoint
Before starting the intervention and 2 months after the intervention
Method of measurement
Beck Depression Inventory questionnaire

4

Description
Anxiety severity score in Beck Anxiety Inventory (primary outcome)
Timepoint
Before starting the intervention and 2 months after the intervention
Method of measurement
Beck Anxiety Inventory questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Lifestyle modification intervention was performed for two months. (Interventions include: adequate physical activity training as 150 minutes per week –medium speed walking-no smoking, and alcohol psychology consultants).
Category
Lifestyle

2

Description
Intervention group: Diet change to LOW FODMAP for two months period. The training was done by a dietician, and written protocol
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Afrooz Ahmadi Ghadikolaee
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2541
Email
dr.afahmadi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Shahab Banihashem
Street address
Velemjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2540
Email
shb_banihashem@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Sadeghi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2541
Email
amirsadeghimd@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Shahab Banihashem
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2540
Email
shb_banihashem@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Shahab Banihashem
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2540
Email
shb_banihashem@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
In order to maintain the research information, the data will not be published, but only in the form of articles and the result of the analysis
Study Protocol
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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