Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001099910p
Ethics application status
Submitted, not yet approved
Date submitted
5/01/2020
Date registered
22/10/2020
Date last updated
22/10/2020
Date data sharing statement initially provided
22/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of a Smart-Phone Application on self- efficacy for adherence to healthy lifestyle behaviors among pregnant women with Gestational Diabetes Mellitus (GDM).
Scientific title
The effectiveness of a Self-Efficacy Enhancing Smart-Phone Application (SEESPA) on self- efficacy for adherence to healthy lifestyle behaviors among pregnant women with Gestational Diabetes Mellitus (GDM).
Secondary ID [1] 300182 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
SEESPA study
Linked study record
This study is the main study of the feasibility study ( ACTRN12619001278123p)

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes Mellitus 315723 0
Condition category
Condition code
Reproductive Health and Childbirth 314011 314011 0 0
Antenatal care
Metabolic and Endocrine 314012 314012 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study intervention. Steps taken to implement the study are:
Baseline data. Baseline demographic data will be collected by trained data collectors. They will collect pre-test questionnaires (a 20 minute form) on demographic characteristics, Diabetes Self-Care Activities Measure (SDSCA), Diabetes Management Self-Efficacy Scales (DMSES), barriers and cues to action for health lifestyles/behaviors. Baseline (pre-test) data will be collected from all participants in all three groups. Participants will be assigned to Intervention group 1 (IG1), Intervention group 2 (IG2), or Control group (C) by a random choice generator using a computerized sequence generation.
IG1 Smart-phone group. In addition to the standard prenatal care, the IG1 group will receive an educational smart-phone application with a detailed training session on basic smart-phone operation and data entry, and an instruction manual with advise to contact the study member if they have questions or face any technical challenges. Participants will be instructed on the study policies for not sharing the access to the smart-phone application with anyone else, informed that the smart-phone application is designed for a research purpose only, and that their usage will be monitored until the end of the study. They will also be told that they are participating in the study as a volunteer, they can leave the study at any time, and that they do not have to answer any question they do not want to. Using the study smart-phone platform, various self-efficacy enhancing strategies will encourage women to maintain the recommended adherence/treatment plan. Access to the smart-phone application will be possible after study enrollment completion of the demographic and pre-test questionnaires. Six weeks following the pre-test, the SDSCA, DMSES, barriers and cues to action questions will be re-administered to all participants at posttest.
IG2 Traditional health education group. The IG2 traditional health education group will receive the standard prenatal care as well as a health education booklet about GDM. The health education content in the booklet will mirror the health education of the smart-phone. Participants will receive the health education booklet immediately after the enrollment in the study, completion of the demographic data, and the pre-test questionnaires. The post-test questionnaires of SDSCA, DMSES, and barriers and cues to action questions will be re-administered to the participants after six weeks following the pretest.
Control group. The control group will receive standard antenatal care on GDM. The standard prenatal care for women with GDM at the Antenatal Clinics include routine antenatal visits, monthly blood sugar profiles, fasting blood sugar test every visit, glucose monitoring at home, and one-to-one individualized education visit with a diabetic dietician as required by the physician. Participants in the Control group will be administered the posttest questionnaires that includes questions on demographics, SDSCA, DMSES, and barriers and cues to action six weeks following the pretest.
Intervention.
The smart-phone GDM health education content will be adapted from the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDKD) health information (NIDDK, 2017). The health education content has been previously translated from English to Arabic by the PI (Al Hashmi et al., 2017). The readability of the contents is suitable for 8th grade reading level. The content includes the following: 1) general information about gestational diabetes such as definition, etiology, risk factors and treatment of GDM; 2) focus on maternal and neonatal complications related to GDM; 3) importance of healthy lifestyle behaviors such as weight management, healthy diet, exercises and self- monitoring of blood glucose (SMBG) level to prevent GDM complications; and 4) measurement to prevent type 2 diabetes post-partum.
Participants will key-in the following information into their smart phone:
Goals. A measureable goal they want to achieve during the study period and their planned action (enhances adherence to recommended healthy lifestyle behaviors).
Physical activities. Multiple types of physical activities planned over a seven-day period (chosen from a video activity list).
Blood glucose levels. Checked on a provided glucometer and recorded three times a day over the length of the study.
Dietary history. Smart-phone photos will guide the reported dietary history of participant by a summary of their daily intake based on inclusion of fruits, vegetables, food rich in fiber, low carbohydrate food, and low fat diet.
Messages. The participants will receive text messages reminder twice a day (8:00 am and 8:00 pm) to check their blood glucose level, maintain healthy eating, and maintain an active lifestyle. The self-reported data on adherence to the recommended healthy behaviors will be available for viewing in a graphical form that thus supporting participant’s adherence to healthy behaviors. The cultural sensitivity aspects and the practicality of the recommended exercises for pregnant women will be considered when preparing the smart-phone application. The proposed smart-phone application is expected to track usage time of each section. Participants’ access to the proposed smart-phone application will be possible after the enrollment in the feasibility study and until four weeks later.
Intervention code [1] 316459 0
Behaviour
Comparator / control treatment
Control group. The control group will receive standard antenatal care on GDM. The standard prenatal care for women with GDM at the Antenatal Clinics include routine antenatal visits, monthly blood sugar profiles, fasting blood sugar test every visit, glucose monitoring at home, and one-to-one individualized education visit with a diabetic dietician as required by the physician. Participants in the Control group will be administered the posttest questionnaires that includes questions on demographics, SDSCA, DMSES, and barriers and cues to action six weeks following the pretest.
Control group
Active

Outcomes
Primary outcome [1] 322420 0
Change in self-efficacy for the adherence to healthy behaviors score as measured by DMSES among intervention group.
Timepoint [1] 322420 0
six weeks post commencement of intervention
Secondary outcome [1] 378406 0
Change in adherence to healthy behaviours means as measured by SDSC among women who have high self-efficacy
Timepoint [1] 378406 0
Six weeks post commencement of intervention

Eligibility
Key inclusion criteria
Participant inclusion criteria include Omani women, 18 years or older, with a single pregnancy, between 22-30 weeks of gestation, diagnosed with gestational diabetes for the first time, attending the study settings during the study timeframe, and able to speak, read and write in the Arabic language.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with multiple gestations, type 1 or type 2 diabetes, chronic medical problems, mental illness, and have pregnancy complications that require complete bed rest will be excluded from the study.

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)
Participants will be assigned to Intervention group 1 (IG1), Intervention group 2 (IG2), or Control group (C) by a random choice generator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample and setting. Sample. The study sample will consist of Omani pregnant women diagnosed with gestational diabetes (GDM). To obtain a good estimate of the effect size, we follow Cohen’s recommendation on effect size to estimate the appropriate number of subjects required for the given study. Assuming a power of 80 percent, with alpha level 0.05, one tailed and small effect size 0.20 for differences between independent three-population means, a total of 250 subjects are required to be included to answer hypothesis one. We expect an attrition of about 20 percent, so the final estimate for overall sample is 270 pregnant women with GDM, 90 in each group (smart-phone, traditional health education intervention and control). Random sampling of participants will be conducted using a computerized random number generator.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment outside Australia
Country [1] 22202 0
Oman
State/province [1] 22202 0
Muscat

Funding & Sponsors
Funding source category [1] 304615 0
University
Name [1] 304615 0
Sultan Qaboos University
Country [1] 304615 0
Oman
Primary sponsor type
University
Name
Sultan Qaboos University
Address
Al Koudh 66, Muscat, Sultan Qaboos University, College of Nursing, Oman, 123
Country
Oman
Secondary sponsor category [1] 304908 0
None
Name [1] 304908 0
Address [1] 304908 0
Country [1] 304908 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305036 0
Medical Research Ethic Committee
Ethics committee address [1] 305036 0
Al Koudh , Muscat, Sultan Qaboos University, College of Medicine, Oman, 123
Ethics committee country [1] 305036 0
Oman
Date submitted for ethics approval [1] 305036 0
02/03/2020
Approval date [1] 305036 0
Ethics approval number [1] 305036 0

Summary
Brief summary
This study is an extension of a previously two funded interventional research studies titled “Effect of Health Education Intervention on Self-Efficacy for Adherence to Healthy Behaviors among Women with Gestational Diabetes Mellitus (GDM)” and “The Accessibility and the Feasibility of a Self-Efficacy Enhancing Smart-Phone Application (SEESPA) among pregnant women with Gestational Diabetes Mellitus (GDM)”, conducted by the primary principal investigator (PI). The original study found the GDM educational program was highly effective among adult Omani women with GDM (Al Hashmi et al., 2018). The main purpose of this proposed study is to compare the effectiveness of a self-efficacy enhancing smart-phone application versus the traditional health education and the standard prenatal care (control) provided for women with GDM. The proposed study examines the improvement of self-efficacy and adherence to healthy lifestyle behaviors in a population of Omani pregnant women with GDM.
We hypothesize that providing a self-efficacy enhancing smart-phone application (SEESPA) will enhance self-efficacy, and thus increase adherence to healthy behaviors (specifically healthy diet, exercise and self-monitoring of blood glucose [SMBG]). Subsequently, these actions are expected to improve pregnancy outcomes of women with GDM and their neonates.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99054 0
Dr Iman Al Hashmi
Address 99054 0
Al koudh 66
Sultan Qaboos University, College of Nursing, Assistant Dean of Clinical Affairs,
Office 2043
Country 99054 0
Oman
Phone 99054 0
+0096899244418
Fax 99054 0
Email 99054 0
[email protected]
Contact person for public queries
Name 99055 0
Dr Iman Al Hashmi
Address 99055 0
Al koudh 66
Sultan Qaboos University, College of Nursing, Assistant Dean of Clinical Affairs,
Office 2043
Country 99055 0
Oman
Phone 99055 0
+0096899244418
Fax 99055 0
Email 99055 0
[email protected]
Contact person for scientific queries
Name 99056 0
Dr Iman Al Hashmi
Address 99056 0
Al koudh 66
Sultan Qaboos University, College of Nursing, Assistant Dean of Clinical Affairs,
Office 2043
Country 99056 0
Oman
Phone 99056 0
+0096899244418
Fax 99056 0
Email 99056 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
To maintain patient confidentiality


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6298Ethical approval  [email protected]
6299Informed consent form  [email protected] 378999-(Uploaded-05-01-2020-19-24-40)-Study-related document.docx
6300Statistical analysis plan    378999-(Uploaded-05-01-2020-19-26-26)-Study-related document.docx



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.