Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001112853
Ethics application status
Approved
Date submitted
10/05/2021
Date registered
23/08/2021
Date last updated
6/06/2022
Date data sharing statement initially provided
23/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Motivational Psychological Intervention Aimed at University Students' Health
Scientific title
Examining the Effectiveness of Modified Motivational Interviewing Intervention in Improving University Students’ Health: A Mixed Methods Study
Secondary ID [1] 304182 0
20210179.
Universal Trial Number (UTN)
Trial acronym
EMMII
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Health Promotion 321874 0
Condition category
Condition code
Public Health 319601 319601 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The researchers will provide informational materials to the participants. Such materials will be study-specific and will be delivered using both an information sheet and a brief video presentation. The information sheet will provide simple information regarding the intervention and its essential components including definitions and descriptions of the following concepts:
1. Motivational interviewing
2. Change talk
3. Status quo
4. Resistance talk

These concepts will also be covered in a short video presentation prepared by the research team for the purpose of conducting this study. The video and the information sheet will be shared with the participants before launching the intervention.

In this study we will use a modified version of MI interviewing intervention. In the proposed intervention we will ask the participants to deliver a series of brief online presentations (5-10 minutes) regarding behavior change. Participants will be instructed to prepare their presentations around the change talk themes employed in the original MI techniques. These themes include Disadvantages of status quo, advantages of change, intention to change, optimism about change. The administration of modified motivational interviewing intervention will be done in three main phases. First two weeks, the participants will be asked to deliver two online presentations a week. Second phase will include the next two weeks in which the participants will deliver one online presentation a week. In the third phase participants will be asked to deliver one online presentation once every two weeks for the next month. The target behaviors will represent three health domains (physiological, psychological, and cognitive). These domains were selected based on the review of the literature and how college life affect different aspects of health.

To assess and monitor the participants' adherence to the intervention, a weekly report of video recordings will be used. A reminder will be sent to the participants asking them to turn in their videos in a timely manner. Those participants who do not turn in their videos will be contacted directly via the phone and help will be offered by the research team to make sure that the videos are turned in on time.

The proposed intervention in the current study is considered feasible and do not involve any health or financial burdens on the students.
Intervention code [1] 320512 0
Behaviour
Comparator / control treatment
A waiting-list control group will be recruited in the current study. Upon completion of collecting the data from the participants, the data will be analyzed and If the intervention is effective then it will be made available for all participants in the control group after the end of the study. All of the participants will be emailed with the study results offering them the option to enroll in modified motivational interviewing.
Control group
Active

Outcomes
Primary outcome [1] 327458 0
Physical activity will be measured using a smart phone application developed for the purpose of conducting this study.
Timepoint [1] 327458 0
24-hour periods weekly after randomization for three months. The primary endpoint will be final timepoint (3-month post randomization).
Primary outcome [2] 327459 0
Assessment of nutritional status. This is a composite primary outcome and the following will be included in its measurement:
1. Measurement of the participants' Body Mass Index [BMI]. The weights will be obtained using a digital scale. The participants heights will be measured using stadiometer.
2. Healthy Eating Index [HEI-2015], and
3. The Three-Factor Eating Questionnaire-18 [TTFQ-18]).
Timepoint [2] 327459 0
Will be assessed immediately after randomization, and then after one and three months of randomization. The final timepoint (3-month post randomization) will be considered the primary endpoint.
Primary outcome [3] 327460 0
Psychological health will be assessed by measuring the perceived stress and the depressive symptoms among the participants. This is a composite outcome covering the following:
1. The Perceived stress scale-10 will be used to measure stress,
2. Depressive symptoms will be measured by using the Center for Epidemiologic Studies Depression-Revised (CESD-R).
Timepoint [3] 327460 0
Will be assessed immediately after randomization, and then after one and three months of randomization. The final timepoint (3-month post randomization) will be considered the primary endpoint.
Secondary outcome [1] 395168 0
Mindfulness will be measured using the Five Facet Mindfulness Questionnaire (FFMQ).
Timepoint [1] 395168 0
Will be assessed immediately after randomization, and then after one and three months of randomization.
Secondary outcome [2] 395169 0
Cognitive fusion will be measured using the cognitive fusion questionnaire (CFQ).
Timepoint [2] 395169 0
Will be assessed immediately after randomization, and then after one and three months of randomization.
Secondary outcome [3] 399204 0
Impulsivity will be assessed using the Barratt Impulsiveness Scale (BIS-11).
Timepoint [3] 399204 0
Will be assessed immediately after randomization, and then after one and three months of randomization.
Secondary outcome [4] 399205 0
Self-monitoring of behavioral change will be assessed using the Health Education Impact Questionnaire (heiQ).
Timepoint [4] 399205 0
Will be assessed immediately after randomization, and then after one and three months of randomization.

Eligibility
Key inclusion criteria
1) being currently enrolled in the university, and 2) having the ability to participate in the current study and commit to behavioral change.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) students with debilitating illness that could hinder behavioral change, 2) students who are expected to graduate as they might not be able to complete the course of study and inflate the attrition rate.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed. Allocation concealment will be sealed opaque envelopes. The researchers will prepare a total of 90 sealed opaque envelopes; 45 for intervention and 45 for the control group. The envelops will be randomly distributed to the participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation to either the intervention or control group will be performed using odd and even numbers after randomly creating a list of participants using a computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Regarding the sample size, G*Power analysis was used to estimate the sample size required to conduct the experimental phase of the current study. The following parameters were applied a = .05, power = .8, effect size = .15 (small to medium), number of groups = 2, number of measurements = 3 (Faul et al., 2007). The total estimated sample size based on these parameters is 74 students. Considering the repeated measure nature, attrition is likely, and it was estimated at 20%. Therefore, the total number of students to be recruited will be 74 + 16 = 90. This sample will be equally divided into two groups with 45 students in each group.

Quantitative data will be analyzed using SPSS (Version 23). Descriptive statistics and frequencies will be performed. In addition, an investigation of the mean differences will be conducted using repeated measures MANOVA. Follow-up analyses (One-way ANOVA’s and independent t-tests) will also be conducted to detect the exact within and between group differences.

The qualitative data obtained through the focus groups will first be transcribed. Then, thematic analysis will be performed using NVIVO (Version 12). The analysis will be performed by two researchers who will code the data and extract the themes independently. The researchers will then meet and discuss the extracted themes until 100% agreement is achieved.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2021
Actual
2/02/2022
Date of last participant enrolment
Anticipated
1/11/2021
Actual
5/03/2022
Date of last data collection
Anticipated
1/05/2022
Actual
31/05/2022
Sample size
Target
90
Accrual to date
Final
104
Recruitment outside Australia
Country [1] 23685 0
Jordan
State/province [1] 23685 0
Irbid

Funding & Sponsors
Funding source category [1] 308559 0
University
Name [1] 308559 0
Jordan University of Science and Technology
Country [1] 308559 0
Jordan
Primary sponsor type
University
Name
Jordan University of Science and Technology
Address
PO Box 3030
Irbid 22110, Jordan
Country
Jordan
Secondary sponsor category [1] 309409 0
None
Name [1] 309409 0
Address [1] 309409 0
Country [1] 309409 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308501 0
Faculty of Scientific Research, Jordan University of Science and Technology
Ethics committee address [1] 308501 0
Ethics committee country [1] 308501 0
Jordan
Date submitted for ethics approval [1] 308501 0
11/01/2021
Approval date [1] 308501 0
04/05/2021
Ethics approval number [1] 308501 0
16-2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110926 0
Dr Jehad Rababah
Address 110926 0
Jordan University of Science and Technology
Faculty of Nursing
PO Box 3030
Irbid 22110, Jordan
Country 110926 0
Jordan
Phone 110926 0
+962 798 119 119
Fax 110926 0
Email 110926 0
[email protected]
Contact person for public queries
Name 110927 0
Jehad Rababah
Address 110927 0
Jordan University of Science and Technology
Faculty of Nursing
PO Box 3030
Irbid 22110, Jordan
Country 110927 0
Jordan
Phone 110927 0
+962 798 119 119
Fax 110927 0
Email 110927 0
[email protected]
Contact person for scientific queries
Name 110928 0
Jehad Rababah
Address 110928 0
Jordan University of Science and Technology
Faculty of Nursing
PO Box 3030
Irbid 22110, Jordan
Country 110928 0
Jordan
Phone 110928 0
+962 798 119 119
Fax 110928 0
Email 110928 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data sharing is under third party agreement (Jordan University of Science and Technology) that restrict public data sharing.


What supporting documents are/will be available?




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.