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Trial registered on ANZCTR


Registration number
ACTRN12623000362695
Ethics application status
Approved
Date submitted
28/03/2023
Date registered
12/04/2023
Date last updated
12/04/2023
Date data sharing statement initially provided
12/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Psychoeducation intervention for pregnant women with gestational diabetes: A pilot study
Scientific title
The effects of a new psychoeducation intervention on self-efficacy in pregnant women with gestational diabetes in Saudi Arabia: A pilot randomised controlled trial
Secondary ID [1] 309327 0
None
Universal Trial Number (UTN)
U1111-1290-3798
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational diabetes mellitus 329521 0
Pregnancy 329522 0
Condition category
Condition code
Metabolic and Endocrine 326456 326456 0 0
Diabetes
Reproductive Health and Childbirth 326457 326457 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 326458 326458 0 0
Antenatal care
Mental Health 326459 326459 0 0
Anxiety
Mental Health 326460 326460 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following diagnosis of Gestational Diabetes Mellitus (GDM) at 24-28 weeks’ gestation. The researcher will enroll eligible and consenting women. The intervention will be delivered via face-to-face group education session once every week for four weeks with a specific topic for each week. The duration for each session will be one hour. The session includes information on gestational diabetes, diet, exercise and stress management, in the antenatal clinics. The participating women will be given a pamphlet after each session summarizing the session content. Each group will consist of 6 to 10 women. In addition to face-to-face group education sessions, women will receive weekly WhatsApp posts such as motivational statements, pictures, videos, and will be encouraged to interact within the groups.

The face-to-face group education sessions will be held in a private room at the outpatient department. The researcher, who is a nurse and a lecturer in nursing school with more than 10 years' experience, will deliver the face-to-face sessions each week in the form of lecture, interactive activities, short videos about relaxation exercise such as deep breathing exercise. She will send a reminder before face-to-face session to remind women to attend the session and will use attendance checklist. The researcher will also create a WhatsApp group and will send invitation to the intervention group and will send posts and videos to reinforce and remind women about the information obtained in face-to-face sessions. The researcher will be the moderator of the WhatsApp group. She will encourage women to ask questions and share their experiences.

A brief summary of the educational content:
Week1
1- Welcome and orientation of the psychoeducation intervention
2- Defining stress and its effects on your body
3- Relationships between stress, anxiety, depression and gestational diabetes
WhatsApp Posts:
• Sharing experience
• Video on relaxation exercise suitable for pregnant
• Questions and discussion

Week 2:
1- Definition of anxiety and depression
2- Symptoms of anxiety and depression
WhatsApp posts:
• Sharing experience
• Video on deep breathing technique
• Questions and discussion

Week 3:
1- The benefits of physical activities that are appropriate for pregnant women with GDM
2- The impacts of physical activities on mental health
3- Ways to be active in different settings
WhatsApp posts:
• Sharing experience
• Video on simple home-based exercises for pregnant
• Questions and discussion

Week 4:
1- How to prevent gestational diabetes
2- What is mindfulness meditation
3- Wrap up with a psychoeducation activity
WhatsApp posts:
• Sharing experience
• Video on Mindfulness
• Questions and discussion

After completion of the intervention, semi-structured interviews will be conducted for pregnant women to get their feedback about the intervention. Pregnant women who provide their consent and willing to participate will be interviewed by the student researcher. All the interviews will be audio-recorded. Each interview will last for 20 to 30 minutes. The student researcher will interview women until data saturation. It is anticipated that 10 to 15 pregnant women will reach data saturation. The student researcher will follow an interview guide and example of questions are:
1. Please tell me your experience in the program.

2. Please tell me what was most helpful about the program?

3. Please tell me what was least helpful about the program?

4. Please tell me what has been the biggest change for you in managing GDM?

5. Please tell me what are other aspects that you would like to add in order to improve this program?
Intervention code [1] 325762 0
Treatment: Other
Comparator / control treatment
Women in control group will receive usual care only. Pregnant women with GDM follow up with a specialist team including an obstetrician, a diabetic doctor, a dietician, and a health educator nurse. The usual care for women with GDM includes routine antenatal visits, performing Fasting Blood Glucose (FBG) every visit, home monitoring of blood glucose, individualized health education with a nurse educator and a dietician.
Control group
Active

Outcomes
Primary outcome [1] 334305 0
self-efficacy measured by UK-Diabetic Management Self-Efficacy Scale (UK-DMSES)
Timepoint [1] 334305 0
UK-DMSES will be assessed at baseline, immediately post-intervention (at 4th week), and 2 weeks post-intervention completion.
Secondary outcome [1] 420195 0
Knowledge level measured by using Gestational Diabetes Mellitus Knowledge Questionnaire (GDMKQ)
Timepoint [1] 420195 0
GDMKQ will be assessed at baseline, immediately post-intervention (at 4th week), and 2 weeks post-intervention completion.
Secondary outcome [2] 420196 0
Self-care measured by using the Summary of Diabetes Self-Care Activities scale (SDSCA)
Timepoint [2] 420196 0
SDSCA will be assessed at baseline, immediately post-intervention (at 4th week), and 2 weeks post-intervention completion.
Secondary outcome [3] 420197 0
Depression, anxiety and stress level measured by using Depression, Anxiety and Stress Scale-21 Items (DASS-21)
Timepoint [3] 420197 0
DASS-21 will be assessed at baseline, immediately post-intervention (at 4th week), and 2 weeks post-intervention completion.
Secondary outcome [4] 420198 0
Infant’s birth weight will be collected via phone call of the participants.
Timepoint [4] 420198 0
Within the first month after birth
Secondary outcome [5] 420405 0
Type of birth will be collected via phone call of the participants.
Timepoint [5] 420405 0
Within the first month after birth
Secondary outcome [6] 420406 0
Preterm birth will be collected via phone call of the participants.
Timepoint [6] 420406 0
Within the first month after birth
Secondary outcome [7] 420407 0
Neonatal Intensive Care Unit (NICU) admission will be collected via phone call of the participants.
Timepoint [7] 420407 0
Within the first month after birth

Eligibility
Key inclusion criteria
Pregnant women with singleton pregnancy with GDM.
Pregnant women between 28-32 weeks of gestation.
Aged 18 years and older.
Can provide written consent to participate in this research.
Able to access and use WhatsApp.
Able to speak, read, and write in Arabic.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women with chronic diseases including type 1 or 2 diabetes, with pregnancy complications such as preeclampsia, unable to access WhatsApp, and non-Arabic speaking are not eligible to participate.

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 not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The eligible participants will be randomly allocated to either intervention or control group. A simple randomisation with a 1:1 allocation ratio will be applied using computerised random number generator software (www.random.org). Each participant will be informed his/her randomisation allocation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
IBM® SPSS® 24.0 will be used to analyse the data. Descriptive statistics will be used to summarise the socio-demographic and clinical data, including frequencies, percentages, means and standard deviations (SD). The generalised estimation equation (GEE) for repeated measurements will be used to examine the outcomes between groups. The statistical significance will be the P value < 0.05. The intention to treat (ITT) analysis will includes every subject who is randomized to the study. The ITT ignores noncompliance, protocol deviations, withdrawal, and anything that happens after randomization. The missing outcome data for withdrawal elements will be imputed by last observation carried forward (LOCF) method, whereby the last measurement available for each participant before withdrawal is retained in analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/04/2023
Actual
Date of last participant enrolment
Anticipated
25/04/2023
Actual
Date of last data collection
Anticipated
25/04/2024
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment outside Australia
Country [1] 25359 0
Saudi Arabia
State/province [1] 25359 0
Riyadh Province

Funding & Sponsors
Funding source category [1] 313521 0
University
Name [1] 313521 0
The University of Newcastle
Country [1] 313521 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 315298 0
Other
Name [1] 315298 0
Saudi Arabian Cultural Mission (SACM)
Address [1] 315298 0
Gardens Flats, 16 Watson St, Turner ACT 2612
Country [1] 315298 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312708 0
The University of Newcastle Human Research Ethics Committee (HREC)
Ethics committee address [1] 312708 0
University Dr, Callaghan NSW 2308
Ethics committee country [1] 312708 0
Australia
Date submitted for ethics approval [1] 312708 0
22/11/2021
Approval date [1] 312708 0
24/10/2022
Ethics approval number [1] 312708 0
H-2021-0417
Ethics committee name [2] 312711 0
King Fahad Medical City Institutional Review Board
Ethics committee address [2] 312711 0
6496 Makkah Al Mukarrama Road, 12231, Riyadh
Ethics committee country [2] 312711 0
Saudi Arabia
Date submitted for ethics approval [2] 312711 0
19/03/2023
Approval date [2] 312711 0
22/03/2023
Ethics approval number [2] 312711 0
23-134E

Summary
Brief summary
Pregnant women who are diagnosed with GDM may experience high levels of stress and anxiety and are less able to self-manage their gestational diabetes condition. Therefore, the purpose of the research is to test the effectiveness of psychoeducation program for pregnant women with GDM via face-to-face group education and support session via WhatsApp group in Saudi Arabia. Pregnant women will be asked to attend face-to-face group education session once every week for four weeks with a specific topic for each week. They will be asked to join a WhatsApp group. A phone interview for evaluation of the intervention will also be conducted to explore participant’s perspective and acceptability of the content, identify strengths and weakness of the intervention, and seek recommendations for future improvement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125630 0
A/Prof Regina Lee
Address 125630 0
University of Newcastle.University Drive, Callaghan NSW 2308
Country 125630 0
Australia
Phone 125630 0
+61 0438157049
Fax 125630 0
Email 125630 0
[email protected]
Contact person for public queries
Name 125631 0
Mutairah Alshammari
Address 125631 0
University of Newcastle.University Drive, Callaghan NSW 2308
Country 125631 0
Australia
Phone 125631 0
+61 0411848836
Fax 125631 0
Email 125631 0
[email protected]
Contact person for scientific queries
Name 125632 0
Mutairah Alshammari
Address 125632 0
University of Newcastle.University Drive, Callaghan NSW 2308
Country 125632 0
Australia
Phone 125632 0
+61 0411848836
Fax 125632 0
Email 125632 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18737Ethical approval  [email protected] 385643-(Uploaded-28-03-2023-16-08-35)-Study-related document.pdf



Results publications and other study-related documents

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