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Inadequate resources to complete within the required timeline.
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Nearly half of women have obesity and/or hypertension (HTN). Specific to women, pregnancy creates a vulnerable window for excess gestational weight gain (GWG), exacerbating intergenerational risks for obesity, HTN, type 2 diabetes (T2D), and cardiovascular disease (CVD) across the lifespan. Healthy lifestyles are the first-line recommendations for prevention and treatment of overweight/obesity, HTN, T2D, and CVD. The Diabetes Prevention Program (DPP) is a well-established, Centers for Disease Control and Prevention (CDC)-led public health program focusing on healthy lifestyle changes and is effective at reducing 5-7% of body weight, lowering risks for T2D. Interestingly, research investigating the DPP as a lifestyle intervention for other chronic conditions (i.e., overweight/obesity and HTN) is lacking, demonstrating a missed opportunity. The aim of this study is to determine the initial effects of the first 6-months and after receiving the full 12-months of the virtual DPP compared to the DPP expanded with a CDC-approved HTN prevention component (DPP+) on physical activity, diet, weight, and CVD risk factors in 30 prediabetic women (18-45 years old) with a history of excess GWG, overweight/obesity, and HTN. Participants will be recruited through University of Texas Medical Branch (UTMB) community-based clinics using Epic. The Participants will be randomized into 2 groups (DPP and DPP+) and guided through the 12-month virtual DPP or DPP+ program using UTMB DPP personnel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes Prevention Program (DPP) | Active Comparator | CDC-approved 12-month DPP virtual lifestyle program |
|
| Diabetes Prevention Program Plus (DPP+) | Experimental | CDC-approved 12-month DPP virtual lifestyle program expanded to include a CDC-approved module on hypertension prevention and treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Prevention Program Plus (DPP+) | Behavioral | The DPP+ includes the CDC-approved DPP lifestyle program expanded to include a CDC-approved module on hypertension prevention and treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Systolic Blood Pressure at 6 months | Baseline, 6-months | |
| Change from Baseline Systolic Blood Pressure at 12 months | Baseline, 12-months | |
| Change from Baseline Diastolic Blood Pressure at 6 months | Baseline, 6-months | |
| Change from Baseline Diastolic Blood Pressure at 12 months | Baseline, 12-months | |
| Change from Baseline High-density lipoproteins at 6 months | Baseline, 6-months | |
| Change from Baseline High-density lipoproteins at 12 months | Baseline, 12-months | |
| Change from Baseline Low-density lipoproteins at 6 months | Baseline, 6-months | |
| Change from Baseline Low-density lipoproteins at 12 months | Baseline, 12-months | |
| Change from Baseline Triglycerides at 6 months | Baseline, 6-months | |
| Change from Baseline Triglycerides at 12 months | Baseline, 12-months | |
| Change from Baseline Total cholesterol at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 6 months | Measured using the PreventT2 Diabetes Prevention Program questionnaire | Baseline, 6-months |
| Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Crystal Clark Douglas, PhD | University of Texas | Principal Investigator |
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| Diabetes Prevention Program (DPP) | Behavioral | CDC-approved DPP lifestyle program |
|
| Baseline, 6-months |
| Change from Baseline Total cholesterol at 12 months | Baseline, 12-months |
| Change from Baseline Hemoglobin a1c at 6 months | Baseline, 6-months |
| Change from Baseline Hemoglobin a1c at 12 months | Baseline, 12-months |
| Change from Baseline Weight at 6 months | Baseline, 6-months |
| Change from Baseline Weight at 12 months | Baseline, 12-months |
| Change from Baseline Body mass index at 6 months | Baseline, 6-months |
| Change from Baseline Body mass index at 12 months | Baseline, 12-months |
| Change from Baseline Fasting blood glucose at 6 months | Baseline, 6-months |
| Change from Baseline Fasting blood glucose at 12 months | Baseline, 12-months |
| Change from Baseline Serum insulin at 6 months | Baseline, 6-months |
| Change from Baseline Serum insulin at 12 months | Baseline, 12-months |
Measured using the PreventT2 Diabetes Prevention Program questionnaire |
| Baseline, 12-months |
| Change from Baseline Total portions of Fried Food Consumption at 6 months | Measured using the PreventT2 Diabetes Prevention Program questionnaire | Baseline, 6-months |
| Change from Baseline Total portions of Fried Food Consumption at 12 months | Measured using the PreventT2 Diabetes Prevention Program questionnaire | Baseline, 12-months |
| Change from Baseline Objective Total Weekly Physical activity minutes at 6 months | Measured using Fitbit Inspire 2 | Baseline, 6-months |
| Change from Baseline Objective Total Weekly Physical activity minutes at 12 months | Measured using Fitbit Inspire 2 | Baseline, 12-months |
| Change from Baseline Subjective Weekly Physical activity at 6 months | Stanford Brief Leisure-Time Activity Categorical Item (L-CAT 2.2) | Baseline, 6-months |
| Change from Baseline Subjective Weekly Physical activity at 12 months | Stanford Brief Leisure-Time Activity Categorical Item (L-CAT 2.2) | Baseline, 12-months |
| Change from Baseline Visceral adiposity tissue at 6 months | Measured using Dual energy X-ray absorptiometry | Baseline, 6-months |
| Change from Baseline Visceral adiposity tissue at 12 months | Measured using Dual energy X-ray absorptiometry | Baseline, 12-months |
| Change from Baseline C-reactive protein at 6 months | Baseline, 6-months |
| Change from Baseline C-reactive protein at 12 months | Baseline, 12-months |
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D000078064 | Gestational Weight Gain |
| D006973 | Hypertension |
| D050177 | Overweight |
| D009765 | Obesity |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| C407547 | dentin sialophosphoprotein |
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