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| Name | Class |
|---|---|
| Donaghue Medical Research Foundation | OTHER |
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The purpose of this research collaboration between Dr. William Tamborlane, Deputy Directory of the Yale Center for Clinical Investigation (YCCI) and Fair Haven Community Health Center's (FHCHC) Diabetes Prevention Team is to determine the efficacy of an intensive life-style intervention (ILI) program that has been developed and implemented at the FHCHC to prevent the development of diabetes.
This project is a clinical outcome study that merges the expertise of a senior Yale clinical investigator, the clinical and translational research resources of YCCI, the clinical and community expertise of the FHCHC Diabetes Team, and the high-need patient population of FHCHC. In addition to determining the efficacy and cost-effectiveness of an ILI for diabetes prevention in an inner-city community health center setting, this project will evaluate the effectiveness of pooling academic expertise with direct clinical services to disadvantaged, at-risk populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Life-Style Counseling | Experimental | Women with pre-diabetes randomized to the ILI will attend an intensive 12-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the Diabetes Prevention Program (DPP) "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population. |
|
| Usual Care Control | No Intervention | Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Lifestyle Intervention | Behavioral | Women with pre-diabetes randomized to the ILI will attend an intensive 12-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | The change is weight is reported from baseline to 12 months. | Baseline and 12 Months |
| Change in BMI | The change in BMI is reported from baseline to 12 months. | Baseline and 12 Months |
| Change in Percent Body Fat | Change in percent body fat is reported from baseline to 12 months. Body composition by body fat analyzer (TBF-300; Tanita,Arlington Heights, IL) was used. | Baseline and 12 Months |
| Change in Waist Circumference | Change in waist circumference was measured from baseline to 12 months | Baseline and 12 Months |
| Change in Blood Pressure | Change in blood pressure was measured from baseline to 12 months | Baseline and 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity Levels (Self-reported) | 12 months |
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Inclusion Criteria:
In order to be eligible for this study, the following criteria must be met:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fair Haven Community Health Center | New Haven | Connecticut | 06513 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intensive Lifestyle Intervention (ILI) | Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population. Intensive Lifestyle Intervention: Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population. |
| FG001 | Usual Care Control | Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intensive Lifestyle Intervention (ILI) | Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population. Intensive Lifestyle Intervention: Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Weight | The change is weight is reported from baseline to 12 months. | Posted | Least Squares Mean | 95% Confidence Interval | kg | Baseline and 12 Months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care Control | Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Van Name | Yale University School of Medicine | 203-785-5831 | michelle.vanname@yale.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| BG001 | Usual Care Control | Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Usual Care Control | Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate. |
|
|
| Primary | Change in BMI | The change in BMI is reported from baseline to 12 months. | Posted | Least Squares Mean | 95% Confidence Interval | kg/m^2 | Baseline and 12 Months |
|
|
|
| Primary | Change in Percent Body Fat | Change in percent body fat is reported from baseline to 12 months. Body composition by body fat analyzer (TBF-300; Tanita,Arlington Heights, IL) was used. | Posted | Least Squares Mean | 95% Confidence Interval | percent of body fat | Baseline and 12 Months |
|
|
|
| Primary | Change in Waist Circumference | Change in waist circumference was measured from baseline to 12 months | Posted | Least Squares Mean | 95% Confidence Interval | cm | Baseline and 12 Months |
|
|
|
| Primary | Change in Blood Pressure | Change in blood pressure was measured from baseline to 12 months | Posted | Least Squares Mean | 95% Confidence Interval | mm Hg | Baseline and 12 Months |
|
|
|
| Secondary | Physical Activity Levels (Self-reported) | Data was not collected. | Posted | 12 months |
|
|
| 0 |
| 61 |
| 0 |
| 61 |
| 0 |
| 61 |
| EG001 | Intensive Lifestyle Intervention (ILI) | Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population. Intensive Lifestyle Intervention: Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population. | 0 | 61 | 0 | 61 | 0 | 61 |
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