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| ID | Type | Description | Link |
|---|---|---|---|
| 1P60MD006917-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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This study is evaluating two approaches to improving the control blood sugar, and other risk factors for heart disease in overweight and obese adults with type 2 diabetes. The first approach has participants focus on weight loss via reducing food intake and increasing physical activity, while attending weekly group sessions led by trained community health workers for 12 months. The second approach has participants receive education on diabetes self management, which focuses primarily on glucose control, while attending monthly group sessions led by a study staff member for 12 months. We are recruiting persons with type 2 diabetes who live in the Winston-Salem/Forsyth County area of North Carolina who are willing to attend sessions at the Downtown Health Plaza of Wake Forest Baptist Health. We will measure risk factors for heart disease (glucose control, blood pressure, blood cholesterol) and calculate the predicted risk of heart disease, and see which intervention lowers risk to a greater extent at 12 months, as well as 24 months.
The Look AHEAD trial has demonstrated improved risk factor control among overweight or obese diabetes patients who received an intensive lifestyle intervention at both one and four years after enrollment. Translating such findings into accessible and effective weight loss programs is a major public health challenge. We are conducting "Lifestyle Interventions for Treatment of Diabetes" (LIFT Diabetes). The overall goal is to investigate two approaches to improving risk factor control; one which is modeled after Look AHEAD and is designed to achieve 7% weight loss and increase physical activity to > 175 minutes per week among minority and lower income diabetes patients via a 12-month, group based lifestyle intervention, using community health workers supervised by an interventionist. Participants will have up to 4 group visits/month and up to 12 individual contacts/year. The other approach will promote Diabetes Self Management (DSM) by educating participants regarding health behaviors which lead to improved diabetes control; this arm is also 12 months, and is delivered in the clinic by intervention staff via monthly group visits and up to 12 individual contacts/year. We will randomize 260 overweight or obese adults with diabetes to either intervention, and determine the impact on outcomes (UKPDS-estimated CVD risk, risk factor control), weight, cost, resource utilization, and safety at 12 months, and after transitioning back to usual care, at 24 months. The hypotheses are that the community based intervention results in 10% relative reduction in CVD risk compared to clinic-based intervention; the interventions are equivalent with respect to adherence and participant satisfaction; and the community based intervention is associated with lower cost than the clinic based intervention. Translating evidence based, lifestyle strategies, and targeting minority and underserved patients, will yield, if successful, models for addressing diabetes-related health disparities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes Self Management (DSM) | Active Comparator | Diabetes Self Management education, delivered in the clinics, using group-based visits and targeting improved control of hemoglobin A1c and related risk factors. |
|
| Community Lifestyle Weight Loss (LWL) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Lifestyle Weight Loss (LWL) | Behavioral | Changing dietary and physical activity behavior to promote weight loss |
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| Measure | Description | Time Frame |
|---|---|---|
| Predicted Cardiovascular Risk | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | Change (from baseline) in HbA1c at 12 and 24 months between groups will be assessed | 12, 24 months |
| Blood Pressure | Systolic and Diastolic Blood Pressure change from baseline at 12 and 24 months between groups will be assessed |
| Measure | Description | Time Frame |
|---|---|---|
| Health Costs | Costs and resource utilization will be measured | 12, 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alain G Bertoni, MD MPH | Wake Forest University Health Sciences | Principal Investigator |
| Jeffrey Katula, PhD | Wake Forest University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30291086 | Derived | Claudel SE, Bertoni AG. Exploring the Use of Personal Technology in Type 2 Diabetes Management Among Ethnic Minority Patients: Cross-Sectional Analysis of Survey Data from the Lifestyle Intervention for the Treatment of Diabetes Study (LIFT Diabetes). JMIR Diabetes. 2018 Feb 22;3(1):e5. doi: 10.2196/diabetes.8934. | |
| 27733193 | Derived | Effoe VS, Katula JA, Kirk JK, Pedley CF, Bollhalter LY, Brown WM, Savoca MR, Jones ST, Baek J, Bertoni AG; LIFT Diabetes Research Team. The use of electronic medical records for recruitment in clinical trials: findings from the Lifestyle Intervention for Treatment of Diabetes trial. Trials. 2016 Oct 13;17(1):496. doi: 10.1186/s13063-016-1631-7. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Diabetes Self Management (DSM) | Behavioral | Changing diet, physical activity, self monitoring, and medication related behaviors to improve diabetes control |
|
| 12, 24 months |
| Lipids | Changes in the lipid profile (Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglycerides) from baseline to 12 and 24 months between groups will be determined | 12, 24 months |
| Weight Change | Change in weight from baseline at 12 and 24 months will be ascertained | 12, 24 months |
| Predicted Cardiovascular Risk | 24 month change in UKPDS score will be determined and compared across arms. | 24 months |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |