LIFT: Lifestyle Interventions For Two

Overall body weight and weight gain during pregnancy have gone up among all women in the
United States. Higher body weight of the mother at the time of the baby's conception and a
greater weight gain during pregnancy are both associated with more fat in the infant and
later overweight in children. Obesity in children has become a great public health problem.
This study will use the new Institute of Medicine Guidelines for weight gain during
pregnancy. These Guidelines are based on observations showing that women whose weight gain
was within the recommended Guidelines had healthier pregnancies and better pregnancy outcomes
than those who did not follow the Guidelines. It is important for researchers to understand
whether a lifestyle intervention like LIFT can help women have healthier pregnancies and
healthier babies. If the researchers find that a lifestyle intervention positively impacts
the mothers and their babies, then the researchers can help other pregnant women have
healthier pregnancies and babies as well.

This Study, The Lifestyle Intervention For Two (LIFT) Study, is part of the LIFE Moms
consortium, a national project involving seven sites across the US. The purpose of the LIFE
Moms consortium is to study different ways in which women who are overweight or obese can
manage their body weight during pregnancy, and how this may affect them and their baby's
health at birth and through the first year. As part of the LIFE Moms consortium, The LIFT
Study will look how controlled weight gain during pregnancy will impact the health of the
mother and her child. Researchers at Columbia University are investigating the effect of an
intensive lifestyle intervention (i.e. diet and physical activity counseling). The
researchers hope to positively impact not only body weight gain during pregnancy, but also
positively impact infant body fatness and mother's weight loss after pregnancy. The LIFE Moms
researchers are looking at whether too much weight gain in the mother will result in a leaner
baby, and less retention of fat by the mother following pregnancy.

This study is a randomized controlled trial to study the effect, in a cohort of racially and
ethnically diverse group of overweight and obese pregnant women, of an Intensive Lifestyle
Intervention (ILI) compared to Usual Care (UC) on gestational weight gain (GWG), infant
fatness, and mothers' post-delivery weight retention. Women in the ILI arm will receive
intensive counseling during pregnancy and group counseling after delivery regarding behavior,
nutrition, and physical activity change. Visits to counselors will occur semi-monthly and
additional telephone and internet contacts will occur. The mothers' will be assessed at 14
and 36 weeks of pregnancy and at 14 weeks (range 13-15) and 52 (range 48-56) weeks
post-delivery. The measurements will be anthropometry, whole body MRI, EchoMRI, and whole
body plethysmography (BodPod). The infants' measurements will be anthropometry, whole body
MRI, EchoMRI, and whole body plethysmography (PeaPod) for fatness 14 weeks (range 14-15)
weeks and 52 (range 48-56) weeks. Mothers and children will have cardio-metabolic risk
factors measured in plasma. Data will be collected regarding mothers' dietary intake and
physical activity (questionnaires and accelerometry) to assist in counseling. Other data to
be collected include questionnaires on quality of life, socio-economic status. Each mother
will be followed during pregnancy and for a year post delivery. Each infant will be followed
for a year after birth. The researchers have the ability to continue to follow these
participants if further funding is forthcoming, as they are all local to the hospital's
catchment area and to own physicians.

Inclusion Criteria:

- Singleton viable pregnancy

- Gestational age between 9,0 and 15,6

- Body Mass Index of 25 and above

- Age 18 and over

- Ability to contact

Exclusion Criteria:

- Less than 18 years old

- Diagnosis of Diabetes or Hemoglobin A1c (HbA1c)> or = 6.5%

- Known fetal anomaly

- Planned termination of pregnancy

- History of 3 more more consecutive first trimester miscarriages

- Current eating disorder

- Actively suicidal

- Prior or planned bariatric surgery

- Current use of metformin, systemic steroids, antipsychotic agents, anti-seizure
medications, mood stabilizers, attention deficit hyperactivity disorder medications

- Continued use of weight loss medication

- Contraindications to aerobic exercise in pregnancy

- 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 Lifestyle Interventions For Expectant (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

- Smoking

- History of Drug and/or Alcohol Addiction

- Chronic health problems that prohibit regular exercise or known to influence body
composition

- Other chronic disease as determined by investigators

- Claustrophobia (only for participants who elect to have MRI)

- Implanted metal objects that render MRI unsafe (only for participants who elect to
have MRI)

- Lack of support from primary health care provider or family members

- Another member of the household is a study participant or staff member

- Any other medical, psychiatric, social or behavioral factor that in the judgement of
the Principal Investigator (PI) may interfere with study participation or ability to
follow the intervention protocol