- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02386930
Behavioral Lifestyle Intervention Study (BLIS) in Patients With Type 2 Diabetes in UAE: A Randomized Controlled Trial in Real Life Setting
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ajman, United Arab Emirates
- Rashid Centre for Diabetes and Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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.
Clinical Trials on Type 2 Diabetes
-
Antonio Di MauroCompletedType-2 DiabetesItaly
-
DiaMedica Therapeutics IncCompletedDiabetes Type 2Netherlands
-
RenJi HospitalUnknownType 2 Diabetes.China
-
University of Erlangen-Nürnberg Medical SchoolCompletedType 2-diabetesGermany
-
Chengdu Brilliant Pharmaceutical Co., Ltd.Not yet recruitingType 2 Diabetes Mellitus
-
Nanjing First Hospital, Nanjing Medical UniversityRecruitingType 2 Diabetes MellitusChina
-
Xiangya Hospital of Central South UniversityRecruitingType 2 Diabetes MellitusChina
-
University of Alabama at BirminghamCompletedType 2 Diabetes MellitusUnited States
-
Imperial College LondonAstraZeneca; Huma; North West London Collaboration of CCGs (NWL CCGs); Imperial...CompletedType 2 Diabetes MellitusUnited Kingdom
-
Universiti Sains MalaysiaCompleted
Clinical Trials on Behvarioal lifestyle modification
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University of OuluOulu University Hospital; Oulu Deaconess Institute Foundation srCompletedObesity | Physical Activity | Weight Loss | Healthy Obesity, MetabolicallyFinland
-
University of PennsylvaniaSt. Luke's-Roosevelt Hospital CenterCompletedObesity | OverweightUnited States
-
Clínica BazterricaWithdrawn
-
Universität Duisburg-EssenCharite University, Berlin, Germany; University of Witten/Herdecke; Kliniken... and other collaboratorsCompletedHypertension | Metabolic SyndromeGermany
-
Universiti Putra MalaysiaRecruitingEducational Materials (ST-NEPCO) During Nutrition Counselling for Obese ChildrenMalaysia
-
VA Office of Research and DevelopmentActive, not recruitingDiabetes | Impaired Glucose Tolerance | NeuropathyUnited States
-
King Abdullah International Medical Research CenterCompleted
-
Medical University of South CarolinaCompletedWeight Loss | Heart Failure, DiastolicUnited States
-
Rio de Janeiro State UniversityUniversidade Federal do Rio de Janeiro; National Research Council, BrazilCompletedOverweight | Children