Lifestyle Intervention for Treatment of Diabetes (LIFTDiabetes)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01806727|
Recruitment Status : Completed
First Posted : March 7, 2013
Last Update Posted : November 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Overweight Obesity||Behavioral: Community Lifestyle Weight Loss (LWL) Behavioral: Diabetes Self Management (DSM)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lifestyle Intervention for Treatment of Diabetes|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||March 30, 2017|
|Actual Study Completion Date :||March 30, 2017|
Active Comparator: Diabetes Self Management (DSM)
Diabetes Self Management education, delivered in the clinics, using group-based visits and targeting improved control of hemoglobin A1c and related risk factors.
Behavioral: Community Lifestyle Weight Loss (LWL)
Changing dietary and physical activity behavior to promote weight loss
Experimental: Community Lifestyle Weight Loss (LWL)
Participants with type 2 diabetes will be enrolled in a 12 month lifestyle intervention designed to achieve a mean >7% weight loss induced through caloric restriction and increased physical activity. The intervention will be delivered via supervised Community Health Workers (CHWs). Most meetings will be at a community location.
Behavioral: Diabetes Self Management (DSM)
Changing diet, physical activity, self monitoring, and medication related behaviors to improve diabetes control
- Predicted Cardiovascular Risk [ Time Frame: 12 months ]Cardiovascular risk will be estimated by the United Kingdom Prospective Diabetes Study (UKPDS) risk score, which is based on age, gender, diabetes duration, hemoglobin A1c, blood pressure, lipids, and smoking status. The study will compare the mean changes in UKDPS scores between groups at 12 months.
- Hemoglobin A1c [ Time Frame: 12, 24 months ]Change (from baseline) in HbA1c at 12 and 24 months between groups will be assessed
- Blood Pressure [ Time Frame: 12, 24 months ]Systolic and Diastolic Blood Pressure change from baseline at 12 and 24 months between groups will be assessed
- Lipids [ Time Frame: 12, 24 months ]Changes in the lipid profile (Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglycerides) from baseline to 12 and 24 months between groups will be determined
- Weight Change [ Time Frame: 12, 24 months ]Change in weight from baseline at 12 and 24 months will be ascertained
- Predicted Cardiovascular Risk [ Time Frame: 24 months ]24 month change in UKPDS score will be determined and compared across arms.
- Health Costs [ Time Frame: 12, 24 months ]Costs and resource utilization will be measured
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806727
|United States, North Carolina|
|Wake Forest Baptist Health|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Alain G Bertoni, MD MPH||Wake Forest University Health Sciences|
|Principal Investigator:||Jeffrey Katula, PhD||Wake Forest University|