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| Name | Class |
|---|---|
| THE C.B. AND IRENE PENNINGTON FOUNDATION | UNKNOWN |
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The overall objective of this pilot project is to test in 50 women with a history of gestational diabetes mellitus (GDM), the effectiveness and feasibility of an 8 month intensive lifestyle intervention to reduce the rate of metabolic abnormalities within 1 year after delivery.
The objective is in comparison to a group of women not enrolled in the lifestyle intervention, 8 months of intensive lifestyle intervention aimed at promoting 7% weight loss through increased physical activity and dietary modification in women with a history of GDM will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | A group matched for age and BMI will be selected to serve as control subjects in this study. |
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| Face-to-face group | Active Comparator | Participants randomized to the face-to-face intervention will attend motivational meetings held once per week in Phase I and biweekly in Phase II. Behavioral sessions will be led by a trained interventionist and will take place at Pennington Biomedical Research Center. |
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| Telehealth Group | Active Comparator | Participants randomized to the Telehealth intervention will receive behavioral counseling through Trestletree, phone system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-intervention group | Behavioral | A pedometer and written material on a healthy lifestyle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of glucose intolerance | To examine the incidence of glucose abnormalities (impaired fasting glucose, impaired glucose tolerance, type 2 diabetes) and health outcomes (changes in body fat, waist circumference and blood lipids)in women with a history of gestational diabetes, 12 months postpartum. | 8 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Weight loss through increased physical activity and dietary modification will achieve similar results when delivered via face-to-face contact (DPP) or via telehealth | 8 months |
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Inclusion Criteria:
Women are required to be enrolled (provided written consent for participation) in the COPSS-GDM study and therefore have met the following inclusion criteria:
Exclusion Criteria:
Exclusion Criteria:
Medical Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Leanne M. Redman, PhD | Pennington Biomedical Research Center | Principal Investigator |
| Karen Elkind-Hirsh, PhD | Womans' Research Hospital | Study Director |
| Catherine Chamagne, PhD | Pennington Biomedical Research Center | Study Chair |
| Timothy S. Church, MD, MPH, PhD | Pennington Biomedical Research Center | Study Chair |
| Eric Ravussin, PhD | Pennington Biomedical Reserach Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| Face to face | Behavioral | Motivational meetings held once per week; Behavioral sessions weill be led by a trained interventionist. |
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| Telehelath Group | Behavioral | Participants will speak to Trestletree personnel once a week via phone. |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |