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Completed

NCT Number: NCT02386930

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rashid Centre for Diabetes and Research

Ajman, United Arab Emirates

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behvarioal lifestyle modification

Behavioral

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

Primary outcomes

  1. HbA1c%

    Time frame: 6 months

Secondary outcomes

  1. Weight

    Time frame: 6 months

  2. Body composition analysis

    Time frame: 6 months

  3. Lipid profile ( serum cholesterol, LDL, HDL, triglycerides)

    Time frame: 6 months

  4. Blood presssure (systolic and diastolic)

    Time frame: 6 months

  5. carbohydrates intake in grams

    Time frame: 6 months

  6. physical exercise in minutes per day

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Rashid Centre for Diabetes and Research

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 12, 2015
Registry last updated
Mar 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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