The effectiveness of a Smart-Phone Application on self- efficacy for adherence to healthy lifestyle behaviors among pregnant women with Gestational Diabetes Mellitus (GDM).

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.