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Trial registered on ANZCTR


Registration number
ACTRN12619001278123p
Ethics application status
Submitted, not yet approved
Date submitted
19/06/2019
Date registered
16/09/2019
Date last updated
16/09/2019
Date data sharing statement initially provided
16/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Accessibility and the Feasibility of a Self-Efficacy Enhancing Smart-Phone Application among pregnant women with Gestational Diabetes Mellitus.
Scientific title
The Accessibility and the Feasibility of a Self-Efficacy Enhancing Smart-Phone Application (SEESPA) among pregnant women with Gestational Diabetes Mellitus (GDM).
Secondary ID [1] 298543 0
None
Universal Trial Number (UTN)
U1111-1235-6889
Trial acronym
SEESPA
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Gestational diabetes 313363 0
Condition category
Condition code
Metabolic and Endocrine 311807 311807 0 0
Diabetes
Reproductive Health and Childbirth 311993 311993 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sample and setting. Fifteen Omani pregnant women with gestational diabetes (GDM) will be sampled from the antenatal clinic at Sultan Qaboos University Hospital. Random sampling of the clinic roster list of 100 GDM patients will be conducted using a computerized random number generator.
Pilot-test. The 15 participants will be consented following protection of human subjects approval of the study which will be obtained from the Research Committee at SQUH as well as from the University of California, Los Angeles (UCLA). A two- phases screening procedure will assess participants’ eligibility for pilot-test participation. First, potential participants will complete a self-administered screening form during their antenatal appointment visit in order to determine their eligibility for participating in the pilot. Second, a trained data collector will invite eligible participants to enroll in the pilot study. A training session will be provided by the PI to the data collectors one week before data collection following the JHSPH Human Subjects Research Ethics Field Training Guide.
Active (signed) informed consent will be obtained from all of enrolled participants. A 10-minute meeting with the data collector will follow for instruction on smart-phone operation data entry steps required for recording participant responses in the smart-phone.

Participants will be instructed to use the smart-phone application on a daily basis as deemed convenient by the participants for four weeks and will be asked not to share the smart-phone application to others.

The participants will be informed that the smart-phone application is designed for research purposes only and their usage will be monitored until the end of the trial period. A focus group session with the 15 member sample at the end of four weeks will determine the accessibility of the smart-phone application and will identify barriers to usage. Two open-ended questions will be asked in the focus group: 1) How was your experience with the trial of the proposed smart-phone application in terms of usefulness, effectiveness and satisfaction to improve their self-efficacy and adherence to healthy behaviors, and 2) what are the perceived barriers for using the proposed smart-phone application. Usage data of the smart-phone application will be downloaded from the participant’s phones at the end of the trial for data analysis. The data collected through the smartphone application will be encrypted and will be secured via password on the computer. Information obtained from the pilot-test focus group will aid in the material development, improved protocol and procedures (lifting barriers to use, etc.) of the proposed study. At the end of the pilot test, all of the participants involved in this study will receive a thank you card as an appreciation for the participation time they spent during the study and for travel expenses.

Intervention: A panel of seven volunteer experts, recruited from the study site, will assist in designing the smart-phone themes. These individuals include one expert in informatics and technology, one diabetes nurse, one diabetologist, and four nurse researchers. The smart-phone application has six core sections: 1) health education content about GDM, 2) note on goal setting and action plan, 3) videos regarding the recommended physical activities, 4) video about the steps for blood glucose monitoring, 5) photo examples of the recommended healthy diet, 6) track of the recommended healthy behaviors, and 7) progress charts of daily self-reported data on healthy diet, physical activity and blood glucose monitoring.
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] 314797 0
Lifestyle
Intervention code [2] 314935 0
Treatment: Devices
Comparator / control treatment
'No control group'
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320477 0
Composite primary outcome 1:

Inform study authors about the feasibility of a self-efficacy-enhancing smart-phone application among pregnant women with gestational diabetes.

How it is assessed:
Feasibility will be determined by rates of recruitment, retention rate, and participant completion of the intervention, administering questionnaires at baseline and post-intervention, success rate of transmitting health text messages, rate of participants acknowledging recipient of text messages, participants success rate of entering blood glucose readings on a daily basis, participants success rate of tracking daily food intake, participants success rate of tracking daily physical activity.
Timepoint [1] 320477 0
Four weeks, post intervention or use of smart-phone application
Secondary outcome [1] 374120 0
Composite secondary outcome 1:
Inform study authors about the accessibility of a self-efficacy-enhancing smart-phone application among pregnant women with gestational diabetes.

How it is assessed:
Accessibility will be determined by usage data of the smart-phone application and by conducting a post-intervention focus group discussion session. Two open-ended questions will be asked in the focus group: 1) How was your experience with the trial of the proposed smart-phone application in terms of usefulness, effectiveness and satisfaction to improve their self-efficacy and adherence to healthy behaviors, and 2) what are the perceived barriers for using the proposed smart-phone application. Usage data of the smart-phone application will be downloaded from the participant’s phones at the end of the trial for data analysis.
Timepoint [1] 374120 0
Four weeks, post intervention or use of smart-phone application

Eligibility
Key inclusion criteria
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
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with multiple gestations, diagnosed with type 1 or type 2 diabetes, chronic medical problems, mental illness, and have pregnancy complications that require complete bed rest

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data analysis plan. Data will be entered into a computer and analyzed using Statistical Package for the Social Sciences (SPSS) software, version 24 (IBM Corp, 2016). Entered data will be doubled checked manually in order to maintain data accuracy. Prior to data analysis, frequencies and summary statistics will be checked periodically to ensure sufficient data are available for each variable planned in the analysis. Descriptive statistics and graphical summaries will be obtained for all key outcome and variables to check for outliers, missing data and the need for transformations or non-parametric methods.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2019
Actual
Date of last participant enrolment
Anticipated
15/11/2019
Actual
Date of last data collection
Anticipated
16/12/2020
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 21621 0
Oman
State/province [1] 21621 0
Muscat

Funding & Sponsors
Funding source category [1] 303090 0
University
Name [1] 303090 0
Internal Grant from Sultan Qaboos University
Country [1] 303090 0
Oman
Primary sponsor type
University
Name
Sultan Qaboos University
Address
Al Koudh 66, Muscat, 123, Oman
Country
Oman
Secondary sponsor category [1] 303072 0
None
Name [1] 303072 0
Address [1] 303072 0
Country [1] 303072 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303635 0
Medical research ethic committee
Ethics committee address [1] 303635 0
Al Koudh 35, Muscat 123, Oman
Ethics committee country [1] 303635 0
Oman
Date submitted for ethics approval [1] 303635 0
20/06/2019
Approval date [1] 303635 0
Ethics approval number [1] 303635 0

Summary
Brief summary
The main purpose of this proposed study is to examine the accessibility and the feasibility of a self-efficacy-enhancing smart-phone application. This study will be the first phase of a multi-phases project that ultimately aims 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. Following a pilot-test of the smart-phone operations, the project will be conducted in four phases. Phase 1 examines initial accessibility of the targeted population and determines the feasibility of using the smart-phone application. Phase 2 tests and assesses the use of a smart-phone in improving women’s self-efficacy for adherence to healthy behaviors. This is followed by Phase 3 that determines the maternal-neonatal outcomes of women with GDM, as well as determining the predictors of the adherence to healthy behaviors from women’s demographic and physiological characteristics, and Phase 4 tests the cost-effectiveness of the proposed project.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94342 0
Dr Iman Al Hashmi
Address 94342 0
Al Koudh 66, Assistant Dean of Clinical Affairs, College of Nursing, Sultan Qaboos University, Muscat, 123, Oman
Country 94342 0
Oman
Phone 94342 0
+968 99244418
Fax 94342 0
Email 94342 0
[email protected]
Contact person for public queries
Name 94343 0
Iman Al Hashmi
Address 94343 0
Al Koudh 66, Assistant Dean of Clinical Affairs, College of Nursing, Sultan Qaboos University, Muscat, 123, Oman
Country 94343 0
Oman
Phone 94343 0
+968 99244418
Fax 94343 0
Email 94343 0
[email protected]
Contact person for scientific queries
Name 94344 0
Iman Al Hashmi
Address 94344 0
Al Koudh 66, Assistant Dean of Clinical Affairs, College of Nursing, Sultan Qaboos University , Muscat, 123, Oman
Country 94344 0
Oman
Phone 94344 0
+968 99244418
Fax 94344 0
Email 94344 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 confidentiality


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2393Informed consent form    377821-(Uploaded-19-06-2019-17-40-22)-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
SourceTitleYear of PublicationDOI
EmbaseDevelopment, feasibility and acceptability of a self-efficacy-enhancing smartphone application among pregnant women with gestational diabetes mellitus: single- arm pilot clinical trial.2022https://dx.doi.org/10.1186/s12884-022-04684-1
N.B. These documents automatically identified may not have been verified by the study sponsor.