Gestational Weight Gain, Hypertension, Overweight or Obesity, Prediabetic State
Conditions
Keywords
Prediabetic State, Gestational Weight Gain, Hypertension, Overweight or Obesity, Women's Health, Cardiovascular disease
Brief summary
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.
Interventions
BEHAVIORALDiabetes Prevention Program Plus (DPP+)
The DPP+ includes the CDC-approved DPP lifestyle program expanded to include a CDC-approved module on hypertension prevention and treatment
BEHAVIORALDiabetes Prevention Program (DPP)
CDC-approved DPP lifestyle program
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Women with prediabetes and eligible for the DPP, overweight/obesity, HTN (diagnosed or 3 successive high blood pressure readings), and history of excess gestational weight gain during most recent pregnancy
Exclusion criteria
* Pregnant and lactating women, participants planning to move out of Galveston County within the next year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline Triglycerides at 12 months | Baseline, 12-months |
| Change from Baseline Body mass index 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 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 Weight at 12 months | Baseline, 12-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 |
| Change from Baseline Total cholesterol at 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 6 months | Baseline, 6-months | Measured using the PreventT2 Diabetes Prevention Program questionnaire |
| Change from Baseline Total portions of Combined Weekly Fruit and Vegetable Consumption at 12 months | Baseline, 12-months | Measured using the PreventT2 Diabetes Prevention Program questionnaire |
| Change from Baseline Total portions of Fried Food Consumption at 6 months | Baseline, 6-months | Measured using the PreventT2 Diabetes Prevention Program questionnaire |
| Change from Baseline Total portions of Fried Food Consumption at 12 months | Baseline, 12-months | Measured using the PreventT2 Diabetes Prevention Program questionnaire |
| Change from Baseline Objective Total Weekly Physical activity minutes at 6 months | Baseline, 6-months | Measured using Fitbit Inspire 2 |
| Change from Baseline Objective Total Weekly Physical activity minutes at 12 months | Baseline, 12-months | Measured using Fitbit Inspire 2 |
| Change from Baseline Subjective Weekly Physical activity at 6 months | Baseline, 6-months | Stanford Brief Leisure-Time Activity Categorical Item (L-CAT 2.2) |
| Change from Baseline Subjective Weekly Physical activity at 12 months | Baseline, 12-months | Stanford Brief Leisure-Time Activity Categorical Item (L-CAT 2.2) |
| Change from Baseline Visceral adiposity tissue at 6 months | Baseline, 6-months | Measured using Dual energy X-ray absorptiometry |
| Change from Baseline Visceral adiposity tissue at 12 months | Baseline, 12-months | Measured using Dual energy X-ray absorptiometry |
| Change from Baseline C-reactive protein at 6 months | Baseline, 6-months | — |
| Change from Baseline C-reactive protein at 12 months | Baseline, 12-months | — |
Outcome results
None listed