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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

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]

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

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Diet and Nutrition

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]

Behaviour

Intervention code [2]

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]

Any change in mental distress among study participants was measured using the DASS-21 tool.

Timepoint [1]

3 Months post-enrolment

Secondary outcome [1]

Any change in dietary behavior is assessed using the Diet Quality Questionnaire.

Timepoint [1]

Baseline, post-intervention and 3-months follow-up

Secondary outcome [2]

Any change in self-esteem was measured using Rosenberg Self-esteem Scale.

Timepoint [2]

Baseline, post-intervention, and after 3 months of follow-up.

Secondary outcome [3]

Any change in well-being was measured using the Warwick Edinburgh Mental Well-being Scale.

Timepoint [3]

Baseline, post-intervention and 3-months follow-up

Secondary outcome [4]

Anthropometric measurement changes will be measured through weight measuring machine, a stadiometer for height, and a body composition analyzer

Timepoint [4]

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?

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]

Pakistan

State/province [1]

Khyber Pakhtunkhwa

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Unfunded

Address [1]

Not applicable

Country [1]

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]

Individual

Name [1]

Muhammad Subhan Nazar

Address [1]

Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan.

Country [1]

Pakistan

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Research Ethics/Bioethics committee University of Haripur

Ethics committee address [1]

Directorate of Advance Studies & Research Board, The University of Haripur, Hattar Road Haripur 22620, Khyber Pakhtunkhwa, Pakistan.

Ethics committee country [1]

Pakistan

Date submitted for ethics approval [1]

20/02/2023

Approval date [1]

28/02/2023

Ethics approval number [1]

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

A/Prof Shahbaz Ahmad Zakki

Address

Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan.

Country

Pakistan

Phone

+92995615330

Fax

[email protected]

Contact person for public queries

Name

Shahbaz Ahmad Zakki

Address

Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan.

Country

Pakistan

Phone

+92995615330

Fax

[email protected]

Contact person for scientific queries

Name

Shahbaz Ahmad Zakki

Address

Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan.

Country

Pakistan

Phone

+92995615330

Fax

[email protected]

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: [email protected]
Tel: +92-333-6362383

What supporting documents are/will be available?

Doc. No.	Type	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.

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