A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Assessment of physiological stress and sleep pattern


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-60 years Body Mass Index (BMI > 25 Kg/m2) T2DM Exclusion Criteria: Age < 18 and > 60 years BMI < 25 Kg/m2) Type 1 DM Diagnosis of atrial fibrillation and/or atrial flutter and/or bundle branch block heart transplantation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Assessment of physiological stress and sleep pattern 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 | Behavioral: Assessment of physiological stress and sleep pattern<br>* 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.<br>|
| No Intervention: Control Group<br>The control protocol only includes (i) information session (ii) pre-assessment (initial assessment and (iii) post-assessment (second assessment) of stress and recovery levels and sleep patterns. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | Measurement of body weight at the site visit pre/post the intervention | 6 months | 
| Change in BMI | Measurement of BMI at the site visit pre/post the intervention | 6 months | 
| Change in HbA1c | Measurement of HbA1c at the site visit pre/post the intervention | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Physiological Stress, Sleep Pattern