The Accessibility and the Feasibility of a Self-Efficacy Enhancing Smart-Phone Application among pregnant women with Gestational Diabetes Mellitus.

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.