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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02386930
Enrollment
35
Registered
2015-03-12
Start date
2013-07-31
Completion date
2014-06-30
Last updated
2015-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Cognitive behavior therapy, Lifestyle modification, HbA1c, Carbohydrates

Brief 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.

Interventions

BEHAVIORALBehvarioal 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

Sponsors

Rashid Centre for Diabetes and Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
HbA1c%6 months

Secondary

MeasureTime frame
Body composition analysis6 months
Lipid profile ( serum cholesterol, LDL, HDL, triglycerides)6 months
Weight6 months
carbohydrates intake in grams6 months
physical exercise in minutes per day6 months
Blood presssure (systolic and diastolic)6 months

Countries

United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026