Behavioral Lifestyle Intervention Study (BLIS) in Patients With Type 2 Diabetes in UAE: A Randomized Controlled Trial in Real Life Setting

March 7, 2015 updated by: Sarah Qassim Abdi, Rashid Centre for Diabetes and Research
The primary purpose of this study is to develop a behavioral lifestyle intervention and evaluate its effectiveness in improving the glycemic control in patients with type 2 diabetes in real life setting. This is because ambiguity still exists on the effectiveness of behavioral lifestyle interventions in routine clinical practice despite of the efficacy of large randomized controlled trials, suggesting the need for more research in this area.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Females or males. Type 2 diabetes. BMI (kg/ m²) ≥ 25. Age 18-60 years old. HbA1c > 7%.

Exclusion Criteria:

major physical activity disability that restricts participation in moderate physical activity.

serious heart condition like heart failure, heart attack, stroke within the last 3 months.

participating in a weight management or lifestyle program. presence of proliferative retinopathy or kidney failure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Behavrioal Lifestyle modification
Behavioral: Behvarioal lifestyle modification
A six months behavioral lifestyle program composed of 8 sessions; 4 individual consultations and 4 telephonic calls. The cognitive behavior theory (CBT) is the underpinning theory for the lifestyle intervention; hence CBT behavioral strategies like self monitoring and goal setting are used to improve compliance to healthy lifestyle practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c%
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: 6 months
6 months
Body composition analysis
Time Frame: 6 months
6 months
Lipid profile ( serum cholesterol, LDL, HDL, triglycerides)
Time Frame: 6 months
6 months
Blood presssure (systolic and diastolic)
Time Frame: 6 months
6 months
carbohydrates intake in grams
Time Frame: 6 months
6 months
physical exercise in minutes per day
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rashid Centre for Diabetes and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 7, 2015

First Submitted That Met QC Criteria

March 7, 2015

First Posted (Estimate)

March 12, 2015

Study Record Updates

Last Update Posted (Estimate)

March 12, 2015

Last Update Submitted That Met QC Criteria

March 7, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 032013-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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