Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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)
Scientific title
Effectiveness of psycho-education on healthy dietary behavior and mental health of university students: An interventional study
Secondary ID [1] 309291 0
None
Universal Trial Number (UTN)
U1111-1290-2090
Trial acronym
MIND-FUEL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological Distress 329470 0
Condition category
Condition code
Mental Health 326406 326406 0 0
Depression
Mental Health 326407 326407 0 0
Anxiety
Diet and Nutrition 326408 326408 0 0
Obesity

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 325800 0
Behaviour
Intervention code [2] 325801 0
Lifestyle
Comparator / control treatment
The participants in the control group will not receive any intervention (dietary behavior change group).
Control group
Active

Outcomes
Primary outcome [1] 334353 0
Any change in mental distress among study participants was measured using the DASS-21 tool.
Timepoint [1] 334353 0
3 Months post-enrolment
Secondary outcome [1] 420365 0
Any change in dietary behavior is assessed using the Diet Quality Questionnaire.
Timepoint [1] 420365 0
Baseline, post-intervention and 3-months follow-up
Secondary outcome [2] 430110 0
Any change in self-esteem was measured using Rosenberg Self-esteem Scale.
Timepoint [2] 430110 0
Baseline, post-intervention, and after 3 months of follow-up.
Secondary outcome [3] 430111 0
Any change in well-being was measured using the Warwick Edinburgh Mental Well-being Scale.
Timepoint [3] 430111 0
Baseline, post-intervention and 3-months follow-up
Secondary outcome [4] 430112 0
Anthropometric measurement changes will be measured through weight measuring machine, a stadiometer for height, and a body composition analyzer
Timepoint [4] 430112 0
Baseline, post-intervention and 3-months follow-up

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.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/06/2023
Date of last participant enrolment
Anticipated
Actual
8/07/2023
Date of last data collection
Anticipated
Actual
25/11/2023
Sample size
Target
120
Accrual to date
Final
117
Recruitment outside Australia
Country [1] 25369 0
Pakistan
State/province [1] 25369 0
Khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 313488 0
Self funded/Unfunded
Name [1] 313488 0
Unfunded
Country [1] 313488 0
Primary sponsor type
Individual
Name
Shahbaz Ahmad Zakki
Address
Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan.
Country
Pakistan
Secondary sponsor category [1] 315261 0
Individual
Name [1] 315261 0
Muhammad Subhan Nazar
Address [1] 315261 0
Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan.
Country [1] 315261 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312676 0
Research Ethics/Bioethics committee University of Haripur
Ethics committee address [1] 312676 0
Directorate of Advance Studies & Research Board, The University of Haripur, Hattar Road Haripur 22620, Khyber Pakhtunkhwa, Pakistan.
Ethics committee country [1] 312676 0
Pakistan
Date submitted for ethics approval [1] 312676 0
20/02/2023
Approval date [1] 312676 0
28/02/2023
Ethics approval number [1] 312676 0
UOH/DASR/2023/1140

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125526 0
A/Prof Shahbaz Ahmad Zakki
Address 125526 0
Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan.
Country 125526 0
Pakistan
Phone 125526 0
+92995615330
Fax 125526 0
Email 125526 0
sazakki@uoh.edu.pk
Contact person for public queries
Name 125527 0
A/Prof Shahbaz Ahmad Zakki
Address 125527 0
Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan.
Country 125527 0
Pakistan
Phone 125527 0
+92995615330
Fax 125527 0
Email 125527 0
sazakki@uoh.edu.pk
Contact person for scientific queries
Name 125528 0
A/Prof Shahbaz Ahmad Zakki
Address 125528 0
Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan.
Country 125528 0
Pakistan
Phone 125528 0
+92995615330
Fax 125528 0
Email 125528 0
sazakki@uoh.edu.pk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Screening of university students regarding psychological distress.
When will data be available (start and end dates)?
The data will be available from May to June 2023.
Available to whom?
Everyone
Available for what types of analyses?
Depending upon data and response rate.
How or where can data be obtained?
Principal Investigator
Name: Shahbaz Ahmad Zakki
Email: sazakki@uoh.edu.pk
Tel: +92-333-6362383


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18766Study protocol  sazakki@uoh.edu.pk 385617-(Uploaded-12-08-2023-05-26-44)-Study-related document.docx
18767Statistical analysis plan  sazakki@uoh.edu.pk Not applicable
18768Informed consent form  sazakki@uoh.edu.pk 385617-(Uploaded-12-08-2023-05-25-59)-Study-related document.docx
18770Ethical approval  sazakki@uoh.edu.pk 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.