Table 2.
Inclusion Criteria | |
Age 18 – 35 at the time of enrollment | |
Consented at or before 20 weeks gestation | |
Intending to be available for a 24-month intervention | |
Plan to deliver in one of the 4 hospitals in Rochester, NY | |
Plan to carry the pregnancy to term | |
Plan to keep the baby | |
Read and understand English | |
Exclusion criteria | |
Study Specific | |
BMI < 18.5 kg/m2 or ≥ 35.0 kg/m2. | |
Multiple gestation. If multiple gestation was diagnosed after enrollment, participant was terminated from the study | |
Medical conditions prior to pregnancy which could influence weight loss or gain: cystic fibrosis, hyperthyroidism, renal insufficiency, proteinuria, cerebral palsy, lupus erythematosus; rheumatoid arthritis, Crohn’s disease (severity and other autoimmune diseases evaluated case by case), ulcerative colitis, maternal congenital heart disease (patients are often underweight); hypertension treated with medication | |
Psychiatric medication associated with major weight gain or loss (e.g. Lithium & Divalproex) Having had three or more consecutive miscarriages (spontaneous abortions), because of the higher probability of another miscarriage. |
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Common Exclusion Criteria to EARLY trials | |
Household member on study staff | |
Past or planned (within the next 24 months) weight loss surgery (e.g. gastric bypass, lap band, or liposuction); current participation in a commercial weight loss program (e.g. Weight Watcher's, Jenny Craig); currently enrolled or planned to enroll in a weight loss or another weight gain prevention study | |
Regular use of systemic steroids, prescription weight loss drugs, and/or diabetes medications (oral or injected- insulin, metformin, byetta, TZDs, other). “Regular use” is defined as “taking this medication most days of the week for the previous month” | |
Current treatment for eating disorder Positive screening for bulimia |
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Cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 months. Revascularization is defined as bypass surgery or stents | |
Mental or psychiatric condition that precludes giving informed consent and completing questionnaires | |
Current treatment for malignancy (other than non-melanoma skin cancer and CIN cervix) or in remission for less than 5 years |