Pregnancy and EARly Lifestyle Improvement Study
Pregnancy and EARly Lifestyle Improvement Study
The investigators propose to conduct a randomized controlled trial in 200 overweight/obese
 pregnant women and their offspring. The prenatal intervention will emphasize improving diet
 and physical activity. The lifestyle intervention will be delivered within an empowerment
 theoretical framework through a combination of group sessions, individual counseling, and by
 monitoring compliance to diet and physical activity to further tailor the intervention. The
 post-partum intervention sessions will include mothers and their offspring and will focus on
 breastfeeding, improving physical activity and quality of the diet and feeding practices
 through the first post-partum year. As part of routine prenatal care, participants in both
 the control and intervention arms will be given health-related advice. Since the majority of
 participants are expected to be eligible for the Women, Infants and Children (WIC) program,
 both groups will also receive assistance through WIC as per their routine policies. Our
 primary outcome is Gestational Weight Gain (GWG). The major secondary outcome of interest is
 infant BMI z-score at 12 months of age, and the investigators will also be evaluating several
 metabolic outcomes in mothers and infants.
Obesity and hyperglycemia in pregnancy are thought to impact fetal growth through
 over-nutrition and may stress the fetal pancreas because of the increased demand for insulin.
 Such intrauterine programming events affect birth weight and raise the offspring's risk
 trajectory for future obesity, type 2 diabetes, cardiovascular disease and premature death.
 Investigators propose to conduct a randomized controlled trial in 200 overweight or obese
 pregnant Puerto Rican women (free of diabetes) and their infants, to favorably impact
 metabolic health in mothers and infants.

 Women presenting will be randomized to a lifestyle modification intervention or standard care
 control group before 16 gestational weeks. The intervention will focus on improving: (1)
 physical activity levels and (2) diet quality and calorie intake. The lifestyle intervention
 will be delivered within an empowerment theoretical framework through individualized
 intervention sessions, intensive group sessions, and by phone calls. The intervention will
 continue through the first postpartum year and will include the infants. A key objective is
 to evaluate whether the intervention optimizes infant BMI z-score. We will also evaluate
 whether the intervention increases the number of women who experience appropriate gestational
 weight gain, and evaluate several additional aims including relating the interventions with
 improved insulin sensitivity and beta-cell function in the women, and insulin concentrations
 adjusted for glucose in their infants.This study will also help us to identify and overcome
 barriers to develop effective ways of intervening during pregnancy to meaningfully improve
 cardio-metabolic risk trajectories of future generations.
Inclusion Criteria:

 -  Singleton viable pregnancy. A twin pregnancy reduced to singleton before 14 weeks by
 project gestational age is acceptable. An ultrasound must be conducted before
 randomization that shows a fetal heartbeat; there should be no evidence of more than
 one fetus on the most recent pre-randomization ultrasound.*

 -  Gestational age at randomization no earlier than 9 weeks 0 days and no later than 15
 weeks 6 days based on an algorithm that compares the last menstrual period (LMP) date
 and data from the earliest ultrasound.*

 -  BMI ≥25 kg/m2 based on first trimester measured weight and on measured height. The
 earliest weight measurement before randomization, measured specifically for the study
 will be used. Reported pre-pregnancy weight will not be used to determine eligibility
 because of the potential for inaccuracy. If the earliest weight measurement is
 conducted at 140 to 146 weeks or 150 to 156 weeks, 1 lb or 2 lbs will be subtracted
 from the measured weight respectively, to adjust to a first trimester weight.*

 -  Age ≥ 18*

 Exclusion Criteria:

 -  Diagnosis of diabetes prior to pregnancy (reported physician diagnosed diabetes other
 than GDM in previous pregnancy or taking insulin or medications to treat diabetes), or
 an HbA1c ≥ 6.5 % or other test result (elevated fasting glucose ≥126 mg/dL/7.0 mmol/L
 or 2 h glucose ≥200 mg/dL/11.1 mmol/L when OGTT is completed) suggestive of
 pre-pregnancy diabetes. All potential participants will have HbA1c performed prior to
 randomization.*

 -  Known fetal anomaly *

 -  Planned termination of pregnancy*

 -  History of three or more consecutive first trimester miscarriages*

 -  Past history of anorexia or bulimia by medical history or patient report. Binge eating
 disorder is not an exclusion*

 -  Current eating disorder diagnosed by EDE-Q questions 2-4 and confirmed after
 discussion with the participant by study staff*

 -  Actively suicidal defined as a value ≥ 2 on the BDI-II question 9*

 -  Prior or planned (within 1 year of expected delivery) bariatric surgery*

 -  Current use of one or more of the following medications: *

 -  Metformin

 -  Systemic steroids

 -  Antipsychotic agents

 -  Anti-seizure medications or mood stabilizers that would be expected to have a
 significant impact on body weight

 -  Medications for ADHD including amphetamines and methylphenidate

 -  Continued use of weight loss medication including OTC and dietary supplements for
 weight loss *

 -  Contraindications to aerobic exercise in pregnancy specified in the ACOG Committee
 Opinion #267, 2002 (reaffirmed 2009) *

 -  Hemodynamically significant heart disease defined as an AHA class II (short of
 breath with exercise) or greater

 -  Restrictive lung disease (e.g. pulmonary fibrosis)

 -  Poorly controlled seizure disorder

 -  Poorly controlled hypertension (blood pressure ≥160/110)

 -  History of extreme sedentary lifestyle (e.g. bed bound)

 -  Orthopedic limitations to aerobic exercise

 -  Severe anemia defined as a hemoglobin < 8 g/dl or hematocrit <24 %

 -  Participation in another interventional study that influences weight control*

 -  Enrollment in this trial in a previous pregnancy*

 -  Intention of the participant or of the care provider for the delivery to be outside
 the LIFE-Moms Consortium hospital*

 -  Participant's unwillingness or inability to commit to a 1 year follow-up of herself or
 her child, including planning to move away*

 -  Past or current intravenous drug use (visual check for injection marks, recorded
 methadone use, self-report)

 -  Self-reported HIV infection (confirmed from medical records or baseline test results)

 -  Inability to functionally participate in group sessions and other study requirements
 on a regular basis during the complete duration of the study, including but not
 limited to the documented use of the accelerometer for the periods required by the
 study

 -  Non Spanish speaking

 -  Plan on giving up infant for adoption

 '*' Core eligibility criterion for the LIFE-Moms Consortium