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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK092271-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Cook County Health | OTHER_GOV |
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The primary aim of the LIFE study is to compare low-income African American diabetes patients in a lifestyle intervention group with those in a standard of care control group on change in glycemic control at 12-months. We hypothesize that, on average, participants in the intervention group will achieve greater glycemic control at 12-months relative to their baseline A1c, than those in the control group.
This project is a randomized controlled trial to test an innovative lifestyle intervention to achieve sustained improvements in glycemic control among low-income African American diabetes patients. The LIFE (Lifestyle Improvement through Food and Exercise) program is a diabetes self-management program focused on diet and exercise, informed by anthropological research on models of food and health among low-income African-Americans. Pilot work demonstrated that the LIFE Program is effective in improving glycemic control among low-income African Americans at 6-months. The main goal of the current study is to determine whether the LIFE Program can achieve sustained improvements in glycemic control for 12 months. The trial will randomize low-income African American adults with diabetes to a control group, which receives standard diabetes education, or an intervention group, which receives the LIFE Program (28 group meetings with peer support telephone calls) followed by a 6-month maintenance phase (quarterly group sessions with monthly peer support phone calls). The primary aim of the proposed research is to compare low-income African American diabetes patients receiving the LIFE Program with those in a standard of care control group on change in glycemic control at 12 months. Our primary hypothesis is that patients in the intervention group will achieve a change in A1c from baseline that is less than patients in the control group. Secondary aims are to compare low-income African American diabetes patients receiving the LIFE Program with those in a standard of care control group on (a) change in glycemic control at 18 months; (b) change in physical activity and total energy intake at 12 months; (c) change in physical activity and total energy intake at 18 months; and (d) to obtain estimates needed for a subsequent trial, including weight, blood pressure, and diabetes-related hospitalizations. For secondary aims we hypothesize that a) the intervention group will achieve a mean 18-month change in A1C that is less than the change in the control group; b) at 12 months, a greater proportion of intervention patients will have achieved the activity goal of 150 minutes of moderate activity per week, and the intervention group will achieve a greater reduction from baseline in mean total energy intake than the control group; and c) at 18 months, a greater proportion of intervention patients will have achieved the activity goal of 150 minutes of moderate activity per week, and the intervention group will achieve a greater reduction from baseline in mean total energy intake than the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Active Comparator |
| |
| Intensive education and support | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive education and lifestyle support | Behavioral | Group classes for 12 months (weekly for 4 months, biweekly for 4 months, monthly for 4 months), weekly peer supporter telephone calls, and diabetes education newsletters every 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | Finger prick on Afinion machine | change from baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | An accelerometer is worn by participants for seven days. International-Physical Activity Questionnaire is administered at baseline, 6 months, 1 year, and 18 months. | change from baseline to 12 months |
| Total Energy Intake |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Lynch, PhD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cook County Health Clinics | Chicago | Illinois | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30963440 | Derived | Lynch EB, Mack L, Avery E, Wang Y, Dawar R, Richardson D, Keim K, Ventrelle J, Appelhans BM, Tahsin B, Fogelfeld L. Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes. J Gen Intern Med. 2019 Jul;34(7):1174-1183. doi: 10.1007/s11606-019-04894-y. Epub 2019 Apr 8. | |
| 25245954 | Derived | Lynch EB, Liebman R, Ventrelle J, Keim K, Appelhans BM, Avery EF, Tahsin B, Li H, Shapera M, Fogelfeld L. Design of the Lifestyle Improvement through Food and Exercise (LIFE) study: a randomized controlled trial of self-management of type 2 diabetes among African American patients from safety net health centers. Contemp Clin Trials. 2014 Nov;39(2):246-55. doi: 10.1016/j.cct.2014.09.003. Epub 2014 Sep 22. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Standard of Care control group | Behavioral | Participants receive 2 diabetes education classes taught by a Certified Diabetes Educator. They also receive diabetes education newsletters every 2 months. |
|
24-hour dietary food recalls
| change from baseline to 12 months |
| Physical Measures | Measurements of weight, waist circumference, and blood pressure. | change from baseline to 12 months |
| Medications | Participants bring all medications to the clinic visit and medication and dosage is recorded. | change from baseline to 12 months |
| D004700 | Endocrine System Diseases |