A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Globally, type 2 diabetes mellitus (DM) and obesity are considered to be the fastest growing
      disorders and their prevalence has increased dramatically over the last twenty years.

      Recent studies have shown that about 19% of UAE population has been diagnosed with DM and 57%
      of Emirati patients with type 2 DM are obese.

      Optimal glycemic control and weight management involve comprehensive lifestyle approaches
      including nutrition recommendations and adequate levels of physical activity.

      However, recent views have suggested that there are other factors, such as sleep deprivation
      and stress, contribute to development of type 2 DM.

      Taking into account the previous findings, the present study was designed to investigate the
      effects of a personalized intervention on weight and glycemic control in Emirati patients
      with type 2 DM. The intervention involves assessment and modification of sleep patterns and
      stress levels.
    

Detailed description: 
      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.
    

Intervention name(s): Assessment of physiological stress and sleep pattern
Intervention type(s): Behavioral
Intervention description(s): The personalized intervention consists of (i) information session (ii) pre-assessment (first assessment) of stress and recovery levels, and sleep patterns (iii) individual feedback sessions and action plans based on the outcomes of the initial assessment (iv) monitoring and follow-ups (v) post-assessment (second assessment) of stress and recovery levels and sleep patterns.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes, Physiological Stress, Sleep Pattern