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Effects of healthy diet in reducing symptoms of premenstrual syndrome and improving quality of life among Omani Adolescents; a randomized controlled open label trial

Protocol summary

Study aim
To study the effects of a healthy and well-balanced diet in reducing symptoms of premenstrual syndrome and improving quality of life among Omani Adolescents
Design
a prospective, open-label, randomized controlled trial of two parallel groups
Settings and conduct
The study will be conducted in three randomly selected secondary schools in Al Seeb Willayah, in Muscat region. Subjects in the intervention group will receive an individual face-to-face dietary consultation by a well-experienced dietician. Subjects in the control group will not receive dietary advice at baseline. Notably, both groups will receive similar advice regarding physical exercise at baseline.
Participants/Inclusion and exclusion criteria
Inclusion: Adolescents in grade 10 or 11, aged 16 years to 19 years, and have regular menstrual cycles. Exclusion: known to have a psychiatric disorder (such as depression, generalized anxiety disorder, post-traumatic stress disorder, psychotic disorders), diabetes, thyroid disease, oral contraceptive use, herbal remedy use for PMS symptoms, or had dietary advice before for PMS symptoms.
Intervention groups
Subjects in the intervention group will receive an individual face-to-face dietary consultation by a well-experienced dietician. Subjects in the control group will not receive dietary advice at baseline.A healthy diet icludes: i) carbohydrates (330-450 g), ii) protein (48-60 g), iii) fibers (19-48 g), iv) energy (2400 kcal), v) calcium (600-960 mg), vi) salt (<5 gm/day) (24) , limit extra salt, caffeine, and sugar intake.
Main outcome variables
Improvements in the severity of premenstrual symptoms and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201129049526N1
Registration date: 2020-12-07, 1399/09/17
Registration timing: prospective

Last update: 2020-12-07, 1399/09/17
Update count: 0
Registration date
2020-12-07, 1399/09/17
Registrant information
Name
Zaleikha Albelushi
Name of organization / entity
Ministry of health,Oman
Country
Oman
Phone
+968 26 724056
Email address
drzulikha.albalushi@moh.gov.om
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-01, 1399/11/13
Expected recruitment end date
2021-06-30, 1400/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of healthy diet in reducing symptoms of premenstrual syndrome and improving quality of life among Omani Adolescents; a randomized controlled open label trial
Public title
A healthy diet and premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescents who are at grade 10 or 11, aged 16 years to 19 years old, and have regular menstrual cycles will be included in the study
Exclusion criteria:
known to have psychiatric disorders (such as depression, generalized anxiety disorder, post-traumatic stress disorder, psychotic disorders), diabetes, thyroid disease, oral contraceptive use, herbal remedy use for PMS symptoms, and those who have had dietary advice before for PMS symptoms.
Age
From 16 years old to 19 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Consecutive or random sampling using computer-generated random number table will be used for the recruitment stage, depending on the prevalence rate of PMS (i.e if the prevalence is high, random sampling will be applied, whereas consecutive sampling will be utilized if there is a limited number of adolescents with PMS). Cluster randomization of schools will be carried to minimize contamination anticipated from recruiting subjects from the same school. Therefore, the intervention and control groups will be derived from different schools.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ministry of Health
Street address
P.O.Box:393, Post code:100, Muscat, Oman
City
Muscta
Postal code
100
Approval date
2020-11-23, 1399/09/03
Ethics committee reference number
MoH/CSR/20/23884

Health conditions studied

1

Description of health condition studied
premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
premenstrual syndrome

Primary outcomes

1

Description
The improvements in the severity of premenstrual symptoms
Timepoint
At baseline and 2 months after intervention
Method of measurement
Daily Record of Severity of Problem (Arabic version)

Secondary outcomes

1

Description
Improvements in quality of life
Timepoint
at baseline and at the end of 2 months of starting the intervention
Method of measurement
The medical outcome study short form-36 (SF-36) and Perceived stress scale PSS

Intervention groups

1

Description
Intervention group :Subjects in the intervention group will receive an individual face-to-face dietary consultation by a well-experienced dietician. She will educate the participants about the importance of healthy diet, evaluate the baseline dietary habits of each participant and give advice on how to modify them. The healthy diet advice is derived from the food-based dietary guidelines (FBDG) that were proposed for Omani adolescents (24). FBDG for Omani adolescents includes a daily intake of the following: i) carbohydrates (330-450 g), ii) protein (48-60 g), iii) fibers (19-48 g), iv) energy (2400 lcal), v) calcium (600-960 mg), vi) salt (<5 gm/day) (24). Subjects will be specifically advised to limit extra salt, caffeine and sugar intake. Special weighted scoops will be provided to each participant in order to estimate the amount of specific food intake at certain meal (e.g. rice, pasta, etc.). Then, all the participants will be instructed to fill in an online application of their type and amount of food intake on a daily basis. The dietician will assess the compliance to healthy diet through the online application and give advice where necessary. A motivational phone consultation for each participant in the intervention group will be carried out by the principal and co-principal investigators once every two weeks throughout the study period. It will basically include motivating the participants to comply with the dietary advice given and find out any challenges that they may have encountered which may impede their adherence. Both groups (intervention and control group) will receive similar advice regarding physical exercise at baseline.
Category
Treatment - Other

2

Description
Control group: Subjects in the control group will not receive dietary advice at baseline. However, dietary counseling for each subject in the control group will be provided at the end of the study by the same dietician. Notably, both groups (intervention and control group) will receive similar advice regarding physical exercise at baseline.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
three randomly selected secondary schools in Al Seeb Willayah, in Muscat region
Full name of responsible person
Zaleikha Issa Al belushi
Street address
Khadraween road
City
Shinas
Postal code
324
Phone
+968 26 724056
Fax
+968 26 724043
Email
albelushi11@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
application for fund was done and still awaiting approval
Full name of responsible person
Ethics committee of center of studies and research in Ministry of health
Street address
Khadraween road
City
Shinas
Postal code
324
Phone
+968 26 724056
Fax
+968 26 724043
Email
albelushi11@hotmail.com
Web page address
https://www.moh.gov.om/
Grant name
application for fund was done and still awaiting approval
Grant code / Reference number
application for fund was done and still awaiting approval
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
application for fund was done and still awaiting approval
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
Ministry of health
Full name of responsible person
Zalekha Issa Ali Al Belushi
Position
Speialist
Latest degree
Specialist
Other areas of specialty/work
Family Physician
Street address
Khadraween road
City
Shinas
Province
North Batinah governorate
Postal code
324
Phone
+968 26 724056
Fax
+968 26 724043
Email
albelushi11@hotmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ministry of health,Oman
Full name of responsible person
Ethics committee of center of studies and research in Ministry of health
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Family Physician
Street address
Khadraween road
City
Shinas
Province
North Batinah governorate
Postal code
324
Phone
+968 26 724056
Fax
+968 26 724043
Email
albelushi11@hotmail.com
Web page address
https://www.moh.gov.om

Person responsible for updating data

Contact
Name of organization / entity
Ministry of health,Oman
Full name of responsible person
Ethics committee of center of studies and research in Ministry of health
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Family Physician
Street address
Khadraween road
City
Shinas
Province
North Batinah governorate
Postal code
324
Phone
+968 26 724056
Fax
+968 26 724043
Email
albelushi11@hotmail.com
Web page address
https://www.moh.gov.om

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
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected deidentified IPD from the study titled: Effects of healthy diet in reducing symptoms of premenstrual syndrome and improving quality of life among Omani Adolescents; a randomized controlled open label trial
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Academic institutions only
Under which criteria data/document could be used
For Systematic Reviews and Metaanalysi
From where data/document is obtainable
Dr.Zaleikha Al Belushi : albelushi11@hotmail.com
What processes are involved for a request to access data/document
Authorized researchers from academic institutions only can get in touch with Dr Zaleikha Al belushi at her above email address.
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