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Trial registered on ANZCTR
Registration number
ACTRN12623001359628
Ethics application status
Approved
Date submitted
1/04/2023
Date registered
21/12/2023
Date last updated
21/12/2023
Date data sharing statement initially provided
21/12/2023
Date results information initially provided
21/12/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
Mental health and nutrition intervention for diet and functioning of university students
(MIND-FUEL)
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Scientific title
Effectiveness of psycho-education on healthy dietary behavior and mental health of university students: An interventional study
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Secondary ID [1]
309291
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None
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Universal Trial Number (UTN)
U1111-1290-2090
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Trial acronym
MIND-FUEL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psychological Distress
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Condition category
Condition code
Mental Health
326406
326406
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0
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Depression
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Mental Health
326407
326407
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0
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Anxiety
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Diet and Nutrition
326408
326408
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The content of the sessions has been designed specifically for this study and prepared by Dr. Muhammad Rizwan, Associate Professor of Clinical Psychology The University of Haripur. He will be the resource person for all the sessions. Additionally, the nutritional session will be delivered following Pakistan Dietary Guidelines for Better Nutrition for Adults by Nutritional Expert Dr. Ijaz ul Haq, Assistant Professor in the Department of Public Health & Nutrition, The University of Haripur, as a resource person. Both sessions will be in interactive mode, and the frequency will be two sessions per week. To check the adherence of sessions, session attendance checklists will be incorporated into the study, whereas, to ensure compliance of interventions by participants, a questionnaire will be developed and validated by relevant experts.
It is important to note that we are not employing any particular meal plan but are counseling participants according to guidelines and will assess their adherence and compliance and how much they will benefit from it in terms of alleviation of psychological distress. In this study, participants for intervention will be divided by the non-randomization method (participant’s choice).
The intervention will be based on six face-to-face sessions at the University of Haripur Center for Counseling and Social Wellbeing (UOH-CCSW) The University of Haripur, Khyber Pakhtunkhwa, Pakistan. Each session will consist of 90 minutes. Session 1 will tell us about the importance of nutrition and provide a diet plan through an expert dietitian and well-being; Session 2 will tell us about stress and well-being; Session 3 includes self-esteem and well-being; Session 4 will tell us about anxiety and well-being; Session 5 will tell us about depression and well-being; and Session 6 will be general feedback and reassessment.
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Intervention code [1]
325800
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Behaviour
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Intervention code [2]
325801
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Lifestyle
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Comparator / control treatment
The participants in the control group will not receive any intervention (dietary behavior change group).
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Control group
Active
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Outcomes
Primary outcome [1]
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Any change in mental distress among study participants was measured using the DASS-21 tool.
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Assessment method [1]
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Timepoint [1]
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3 Months post-enrolment
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Secondary outcome [1]
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Any change in dietary behavior is assessed using the Diet Quality Questionnaire.
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Assessment method [1]
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Timepoint [1]
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Baseline, post-intervention and 3-months follow-up
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Secondary outcome [2]
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Any change in self-esteem was measured using Rosenberg Self-esteem Scale.
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Assessment method [2]
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Timepoint [2]
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Baseline, post-intervention, and after 3 months of follow-up.
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Secondary outcome [3]
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Any change in well-being was measured using the Warwick Edinburgh Mental Well-being Scale.
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Assessment method [3]
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Timepoint [3]
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Baseline, post-intervention and 3-months follow-up
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Secondary outcome [4]
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Anthropometric measurement changes will be measured through weight measuring machine, a stadiometer for height, and a body composition analyzer
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Assessment method [4]
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Timepoint [4]
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Baseline, post-intervention and 3-months follow-up
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Eligibility
Key inclusion criteria
Participants were eligible if they were aged 18–35 years, both male and female participants
from university students for the interventional study Students had a score of greater than 7 on the
Depression, Anxiety, and Stress Scale-21 Depression subscale (DASS-21), The Warwick-Edinburgh Mental Well-being scale (WEMWBS), and Rosenberg self-esteem scale participants whose scores are in the moderate level.
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Minimum age
18
Years
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Maximum age
35
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants were ineligible if they were pregnant women, had a physical disability, drug
addiction, currently dieting, had a history of eating disorders or metabolic disease(s), history
of psychological illness other than depression or anxiety, medical condition that could be
adversely affected by diet change or sickness in the past week
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
15/06/2023
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Date of last participant enrolment
Anticipated
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Actual
8/07/2023
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Date of last data collection
Anticipated
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Actual
25/11/2023
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Sample size
Target
120
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Accrual to date
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Final
117
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Recruitment outside Australia
Country [1]
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Pakistan
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State/province [1]
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Khyber Pakhtunkhwa
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Unfunded
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Address [1]
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Not applicable
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Country [1]
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Primary sponsor type
Individual
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Name
Shahbaz Ahmad Zakki
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Address
Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan.
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Country
Pakistan
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Secondary sponsor category [1]
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Individual
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Name [1]
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Muhammad Subhan Nazar
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Address [1]
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Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan.
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Country [1]
315261
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Pakistan
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Research Ethics/Bioethics committee University of Haripur
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Ethics committee address [1]
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Directorate of Advance Studies & Research Board, The University of Haripur, Hattar Road Haripur 22620, Khyber Pakhtunkhwa, Pakistan.
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Ethics committee country [1]
312676
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Pakistan
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Date submitted for ethics approval [1]
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20/02/2023
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Approval date [1]
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28/02/2023
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Ethics approval number [1]
312676
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UOH/DASR/2023/1140
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Summary
Brief summary
Mental health issues are common among undergraduate and postgraduate university students. University students have a high percentage of mental distress and a significant number of mental health disorders, which can impair college turnover and academic achievement, as well as students' emotional and behavioral abilities and social lives (Eleftheriades, R. et al. 2020). Wellness nutrition includes making appropriate dietary choices, learning what important nutrients the body requires, and understanding how to obtain those nutrients from everyday food sources. Carbohydrates, proteins, lipids (fats), Vitamins, minerals, and water are examples of nutritional components. These nutrients supply energy and regulate biological processes, help in tissue growth and repair, and boost mental health and well-being (Grodner, Escott-Stump, & Dorner, 2016). Diet is thus a preventable risk factor for depression that might benefit from early intervention. While there is compelling observational evidence linking food quality and depression, evidence suggesting a causal association is still developing, particularly in young adults. (Francis, H.M., et al., 2019). The connection between nutrition and mental health is increasingly permeating our daily lives, whether the goal is to improve mood, enhance cognitive function, prevent decline, or even provide beneficial effects in certain brain diseases such as depression, anxiety, stress, wellbeing, and self-esteem. The literature exhibit on the relationship between diet and depression shows the value of bringing nutrition instruction into the therapy room. Nutrition can also aid in the prevention and alleviation of psychological suffering. The study will be carried out under the Helsinki Declaration, with each participant providing written informed consent. The participants will be recruited through DASS-21, WEMWBS, and Rosenberg's self-esteem scale. The study will be carried out in the Center for Counseling and Social Wellbeing (UOH-CCSW) at the University of Haripur, Khyber Pakhtunkhwa, Pakistan. The anticipated outcomes of this study are to find out the prevalence of Depression, anxiety, and stress in university students. Moreover, to assess the relationship between nutrition and restoring mental health The group psychoeducation on healthy dietary behavior intervention is novel research that may reduce depression, anxiety, and stress and is a cost-effective intervention. Dietary group psycho-education intervention may also improve wellbeing and self-esteem.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Shahbaz Ahmad Zakki
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Address
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Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan.
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Country
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Pakistan
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Phone
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+92995615330
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Shahbaz Ahmad Zakki
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Address
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Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan.
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Country
125527
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Pakistan
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Phone
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+92995615330
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Fax
125527
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Shahbaz Ahmad Zakki
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Address
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Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan.
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Country
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Pakistan
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Phone
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+92995615330
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Screening of university students regarding psychological distress.
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When will data be available (start and end dates)?
The data will be available from May to June 2023.
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Available to whom?
Everyone
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Available for what types of analyses?
Depending upon data and response rate.
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How or where can data be obtained?
Principal Investigator
Name: Shahbaz Ahmad Zakki
Email:
[email protected]
Tel: +92-333-6362383
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
18766
Study protocol
[email protected]
385617-(Uploaded-12-08-2023-05-26-44)-Study-related document.docx
18767
Statistical analysis plan
[email protected]
Not applicable
18768
Informed consent form
[email protected]
385617-(Uploaded-12-08-2023-05-25-59)-Study-related document.docx
18770
Ethical approval
[email protected]
385617-(Uploaded-01-04-2023-06-45-52)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF