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A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03644134
Enrollment
51
Registered
2018-08-23
Start date
2013-09-26
Completion date
2015-07-14
Last updated
2018-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes, Physiological Stress, Sleep Pattern

Brief 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.

Interventions

BEHAVIORALAssessment of physiological stress and sleep pattern

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.

Sponsors

Rashid Centre for Diabetes and Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in body weight6 monthsMeasurement of body weight at the site visit pre/post the intervention
Change in BMI6 monthsMeasurement of BMI at the site visit pre/post the intervention
Change in HbA1c6 monthMeasurement of HbA1c at the site visit pre/post the intervention

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026