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

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386930
• Other study ID #: 032013-07
• Status: Completed
• Phase: N/A
• First received: March 7, 2015
• Last updated: March 7, 2015
• Start date: July 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: Rashid Centre for Diabetes and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Arab Emirates: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
United Arab Emirates	Rashid Centre for Diabetes and Research	Ajman

Sponsors (1)

Lead Sponsor	Collaborator
Rashid Centre for Diabetes and Research

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c%		6 months	No
Secondary	Weight		6 months	No
Secondary	Body composition analysis		6 months	No
Secondary	Lipid profile ( serum cholesterol, LDL, HDL, triglycerides)		6 months	No
Secondary	Blood presssure (systolic and diastolic)		6 months	No
Secondary	carbohydrates intake in grams		6 months	No
Secondary	physical exercise in minutes per day		6 months	No