A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns in Obese Type 2 Diabetes Emirati Patients: a Randomized Controlled Clinical Trial.

The present study is a randomized controlled trial which was conducted at Rashid Centre for Diabetes and Research (RCDR) in Ajman which in one of the seven Emirates of the United Arab Emirates (UAE). The study was approved by the research ethics committee of Al Qassimi Clinical Research Centre, Al Qassimi Hospital (Ministry of Health, UAE).

The study population is comprised of Emirati individuals (n = 51) who attending RCDR diabetes clinics in a quarterly basis (an initial visit and three follow-up visits per annum). The participants were recruited from RCDR diabetes clinics and through different methods including (i) direct contact (ii) distribution of informative flyers and (iii) phone calls using Diamond, an electronic medical database of RCDR patients. The screening process involved 110 Emirati patients with T2DM and 51 individuals were eligible to participate in the present trial based on the following inclusion and exclusion criteria. The inclusion criteria were (i) Age between 18-60 years (ii) Body Mass Index (BMI > 25 Kg/m2) and (iii) T2DM. The exclusion criteria were (i) Age < 18 and > 60 years (ii) BMI < 25 Kg/m2) (iii) type 1 DM (iv) diagnosis of atrial fibrillation and/or atrial flutter and/or bundle branch block and (v) heart transplantation.

The eligible participants were randomly allocated into an intervention group (n = 26) and or into a control group (n = 25). Non-compliance was the main obstacle to maintain the same number of the randomized participants in each group and 19% and 24 % of the participants in the intervention and control group, respectively, did not attend the first visit.