Pregnancy Complications in Women With BMI>25 kg/m2 Enrolled in a Healthy Lifestyle and Eating Habits Program: a Randomized Controlled Trial.

Pregnant women, recruited from antenatal clinics, with pre-pregnancy BMI ≥ 25 kg/m2, age >18 years and single pregnancy are enrolled within 12th week at the Obstetric Unit of Policlinico Hospital of Modena.

Exclusion criteria are as follows: twin pregnancies, chronic diseases (i.e., diabetes mellitus, chronic hypertension, untreated thyroid diseases), gestational diabetes mellitus (GDM) in previous pregnancies, smoking during pregnancy, dietary supplements or herbal products known to affect body weight, other medical conditions that might affect body weight, and plans to deliver outside of the Birth Center.

At the first visit, an accurate obstetric history, family history, and personal history is collected for the assessment of exclusion criteria. The blood pressure, height and weight are measured, and the BMI is calculated.

Eligible women are randomly assigned to no intervention (Control group) or the Therapeutic Lifestyle Changes Program (TLC group). Randomization is performed using sealed envelopes(using a computer-generated random allocation). Study randomization is numbered and sealed in white envelops. Randomization occurs in consecutive order at time of the first visit. Due to study design, both gynecologist and dietitian know the allocation of the patient.

Every subject receives care in another institution (Antenatal Clinics of Modena Health program). Hence, women in both groups receive the same antenatal evaluation including two ultrasound examinations and at least 4 obstetric evaluations until term. However, referral gynecologists possibly know the allocated arm of their women.