Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001345370p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
31/03/2026
Date registered
Help: Date registered
9/11/2026
Date last updated
Help: Date last updated
9/11/2026
Date data sharing statement initially provided
Help: Data sharing statement date
9/11/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Maternal Health Enhancement Program to manage Weight gain, Pregnancy Outcomes and Healthy Behaviors in Obese Women in Oman
Scientific title
Effectiveness of Maternal Health Enhancement Program (MHEP) on gestational weight gain, perinatal outcomes and health behavioral regulation among Obese pregnant women in Oman
Additional trial identifiers [1] 316859 0
Nil Known
Universal Trial Number (UTN)
U1111-1337-9115
Trial acronym
MHEP
Related trial records

Health condition
Health condition(s) studied:
Pregnancy 341351 0
Overweight Pregnant Women 341352 0
Obese Pregnant Women 341353 0
Condition category
Condition code
Diet and Nutrition 337422 337422 0 0
Obesity
Public Health 337423 337423 0 0
Health promotion/education
Reproductive Health and Childbirth 337424 337424 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The “Maternal Health Enhancement Programme” will include
• Self-paced moderate paced walking for a pregnant women is described as “ Moderate-paced walking is the ability to walk at a comfortable and sustainable speed (Equivalent to Borg RPE 12 to 14) that does not overexert a pregnant woman though the activity feels somewhat hard but she can still maintain her conversation comfortably and allows for regular rest and wellbeing throughout the workday.”
• The participant can choose her convenient time starting in her second trimester of pregnancy around 16 weeks and is recommended to start with 5000 steps and to gradual increase 500 steps until a maximum of 10000 steps each week for 8 weeks based on how much she can tolerate without discomfort. Intervention Period suggested for 8 weeks but not limited. Participant is encouraged to continue until childbirth.
• Healthy nutritious diet guidelines include a nutrition education infographic emphasizing the importance of balanced diet, how to create a healthy plate, recommended calories, Foods to include based on the Omani Diet Patterns and Foods to avoid. This infographic will be provided on the day of participant recruitment and education provided by the dietician and followed up on a weekly basis by both online meeting and face to face during their next antenatal visit during the intervention period of 8 weeks.
• Daily Motivations/Positive Affirmations related to Self-Love and Importance of Healthy Weight Management in the form of visual illustrations E.g. “My body is strong, capable, and nurturing my baby every day. “, “Every healthy choice I make supports both me and my baby.”. These will be sent through their registered mobile numbers via messaging.
Research Assistants having a background about Maternal Health who have completed their nursing program will introduce and implement the intervention and assist the participants. The MHEP program will be explained face to face at the Antenatal Clinic and detailed instructions will be provided. Daily monitoring of the self-paced walking and following the recommended balanced diet will be monitored via phone call and the WhatsApp app.
The intervention adherence will be monitored by using a “Daily Intervention Recording Sheet” based on the details shared by the participant by messaging by phone. This will be administered by the Research Assistant.
Participant allocation will be in the A-B-A-B sequence where the participants will be allocated to the intervention and the control group in an alternate manner.
Modifications: N/A
Intervention code [1] 333645 0
Lifestyle
Intervention code [2] 333646 0
Behaviour
Description of the comparator or control
Standard Antenatal care (ANC) in the study setting is designed to provide comprehensive and systematic assessment and follow-up for pregnant women. The care includes education, counseling, and regular medical check-ups to monitor the progress of the pregnancy and address any potential complications. In addition to this , the intervention group receives the MHEP and followed up.
Control group
Active

Outcomes
Primary outcome [1] 344946 0
Gestational Weight Gain
Timepoint [1] 344946 0
Second trimester of pregnancy 13 weeks and before the childbirth process begins after 37 weeks in the third trimester.
Primary outcome [2] 344950 0
Readiness to change
Timepoint [2] 344950 0
Second trimester of pregnancy 13 weeks and before the childbirth process begins around 37 weeks.
Primary outcome [3] 346782 0
Confidence to Change
Timepoint [3] 346782 0
Second Trimester of Pregnancy 13 weeks and before the childbirth process begins around 37 weeks.
Secondary outcome [1] 459884 0
Gestational Diabetes Mellitus
Timepoint [1] 459884 0
Third Trimester after 37 weeks. At the time of admission for childbirth.
Secondary outcome [2] 459885 0
Pregnancy Induced Hypertension and its complications – Preeclampsia , Eclampsia
Timepoint [2] 459885 0
Third Trimester after 37 weeks. At the time of admission for childbirth.
Secondary outcome [3] 459886 0
Antepartum Hemorrhage
Timepoint [3] 459886 0
Third Trimester after 37 weeks. At the time of admission for childbirth.
Secondary outcome [4] 459888 0
Premature Rupture of Membrane
Timepoint [4] 459888 0
Third Trimester after 37 weeks. At the time of admission for childbirth.

Eligibility
Key inclusion criteria
Pregnant Women attending the antenatal Out Patient Department with body mass index more than 30 shall be invited to join.
Pregnant Women attending the antenatal Out Patient Department and in their second trimester (13 – 20 weeks).
Pregnant Women willing to participate in the intervention until childbirth process begins.
Minimum age
20 Years
Maximum age
45 Years
Sex
Females
Healthy volunteers
No
Key exclusion criteria
- Pregnant Women with chronic medical conditions – sickle cell, Asthma, Epilepsy
- Pregnant Women with pregnancy complications like low lying placenta, placenta previa.
- Pregnant Women with already identified Type 2 Diabetes Mellitus, Hypertension, Knee Osteoarthritis
- Pregnant Women who are habitual exercises doers already.

Study design
Purpose of the study
Prevention
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
Not yet recruiting
Date of first participant enrolment
Anticipated
18/01/2027
Actual
Date of last participant enrolment
Anticipated
31/12/2027
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 27996 0
Oman
State/province [1] 27996 0
Muscat

Funding & Sponsors
Funding source category [1] 321458 0
University
Name [1] 321458 0
Internal Grant Funding from Sultan Qaboos University
Country [1] 321458 0
Oman
Primary sponsor type
University
Name
Sultan Qaboos University
Address
Country
Oman
Secondary sponsor category [1] 324206 0
None
Name [1] 324206 0
Address [1] 324206 0
Country [1] 324206 0
Other collaborator category [1] 283887 0
Individual
Name [1] 283887 0
Dr. Vidya Seshan College of Nursing , University of Sharjah
Address [1] 283887 0
Country [1] 283887 0
United Arab Emirates
Other collaborator category [2] 283888 0
Individual
Name [2] 283888 0
Dr. Sharifah Shafinaz Binti Sh Abdullah Centre for Nursing Studies, Faculty of Health Sciences, Universiti Teknologi Mara,
Address [2] 283888 0
Country [2] 283888 0
Malaysia
Other collaborator category [3] 283889 0
Individual
Name [3] 283889 0
Dr. S. Rajeswari Faculty of Nursing Sri Ramachandra College of Nursing , Tamilnadu
Address [3] 283889 0
Country [3] 283889 0
India

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 319992 0
Medical Research Ethics Committee
Ethics committee address [1] 319992 0
Ethics committee country [1] 319992 0
Oman
Date submitted for ethics approval [1] 319992 0
04/11/2025
Approval date [1] 319992 0
Ethics approval number [1] 319992 0

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

Contacts
Principal investigator
Name 149070 0
Mrs Frincy Francis
Address 149070 0
Post Box 66, College of Nursing, Sultan Qaboos University, Muscat, Oman.
Country 149070 0
Oman
Phone 149070 0
+968 2414 5460
Fax 149070 0
Email 149070 0
[email protected]
Contact person for public queries
Name 149071 0
Frincy Francis
Address 149071 0
Post Box 66, College of Nursing, Sultan Qaboos University, Muscat, Oman
Country 149071 0
Oman
Phone 149071 0
+968 2414 5460
Fax 149071 0
Email 149071 0
[email protected]
Contact person for scientific queries
Name 149072 0
Frincy Francis
Address 149072 0
Post Box 66, College of Nursing, Sultan Qaboos University, Muscat, Oman
Country 149072 0
Oman
Phone 149072 0
+968 2414 5460
Fax 149072 0
Email 149072 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    MREC# 3758-REF.NO.SQU-EC121-2025-Ms. Frincy Francis- Approval letter (1).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.