A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns

NCT03644134 | Completed DMC

• 2 other identifiers: RashidCDRUniversity of Sharjah
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes, Physiological Stress, Sleep Pattern

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Assessment of physiological stress and sleep pattern BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18-60 years
• Body Mass Index (BMI \> 25 Kg/m2)
• T2DM

You may not qualify if:

• 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

Sponsors & Collaborators

• Rashid Centre for Diabetes and Research: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 18, 2018
• First Posted: August 23, 2018
• Study Start: September 26, 2013
• Primary Completion: June 5, 2014
• Study Completion: July 14, 2015
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share