Lifestyle Intervention Forever: Healthy Weight for Pregnancy and Birth (Pilot Study)
Condition: Pregnancy; Obesity; Weight Gain; Obstetric Complications
MeSH terms: Body Weight; Weight Gain
Study type: Interventional

Summary: 
      Gaining too much weight in pregnancy is associated with adverse pregnancy complications and
      can have a long-term impact on maternal and offspring health, including increased risk for
      obesity and metabolic disease. Preventing excessive gestational weight gain could reduce
      adverse pregnancy outcomes and improve long-term health of mothers and offspring. Thirty
      obese (BMI ≥30) pregnant women will be recruited for this pilot study and randomly assigned
      to the Lifestyle Intervention ForEver (LIFE) program or routine care (RC). Participants will
      be enrolled before 18 weeks gestation and will be followed until 12 weeks after delivery.
      Women in the LIFE program will be given guidance on healthy eating and exercise at their
      regularly scheduled obstetric visits. To increase adherence to the program, a contingency
      management (CM) intervention offering incentives will be used to establish and maintain
      healthy nutrition and physical activity habits, working towards the goal of restricted weight
      gain (± 10lb) during their pregnancy. Three study testing visits will be scheduled for all
      participants: at study entry, 34-36 weeks gestation, and 12 weeks after delivering. Primary
      outcomes include adherence to the LIFE program, weight change in pregnancy and postpartum,
      and objective measures of maternal and offspring health.
    

Detailed description: 
      The ultimate goal of this research is to examine the impact of a healthy lifestyle
      intervention, targeting weight gain restriction during pregnancy in obese women
      (BMI≥30kg/m2), on maternal and fetal outcomes.

      The overarching research program has 3 main objectives:

        1. To establish an effective contingency management behavioral program (LIFE), increasing
           adherence to nutritional recommendations and exercise guidelines during pregnancy.

        2. To examine the impact of the LIFE program on weight gain restriction during pregnancy
           and postpartum weight loss in obese women in comparison to the RC group.

        3. To examine the impact of the LIFE program on short- and long-term maternal and offspring
           outcomes at study enrollment, 34-36 weeks gestation and 3 months postpartum in obese
           women in comparison to the RC group.

             -  Maternal Outcomes: body composition; peak aerobic capacity; maternal
                hormonal/metabolic profiles (fasted blood sample); obstetric parameters (incidence
                of GDM, preeclampsia, cesarean deliveries, obstetric trauma and neonatal
                complications)

             -  Offspring Outcomes: fetal growth pattern (fetal ultrasound); neonatal anthropometry
                assessed ≤ 48 h of birth (crown-heel length, weight, head, chest and waist
                circumferences, skinfold analyses); metabolic markers at birth (cord blood); and
                infant anthropometry at 12 weeks of age (as above).

      The experimental hypotheses to be tested are that participation in the LIFE intervention in
      obese pregnant women will prevent excessive weight gain and/or achieve weight maintenance (±
      10 lb) during pregnancy and will result in 7-10% weight loss at 12 weeks postpartum.
      Secondly, we hypothesize that participation in the LIFE intervention in obese pregnant women
      will be associated with improved aerobic capacity, reduced incidence of obstetric
      complications and reduced rates of LGA as a result of beneficial alterations to metabolic
      intrauterine environment for fetal growth.

      With regard to this IRB application, we will be conducting a pilot and feasibility trial to
      address the following specific aims:

        1. To establish the feasibility of the LIFE program as a large-scale funded project,
           including participant engagement in the intervention and all study visits.

        2. To evaluate the feasibility of the LIFE program in achieving weight maintenance and
           postpartum weight loss targets in obese pregnant women across all three obesity classes.

        3. To develop and refine the study materials for the LIFE program and assessment battery.
    

Intervention name(s): Lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): To establish an effective contingency management behavioral program (LIFE), increasing adherence to nutritional recommendations and exercise guidelines during pregnancy.
To examine the impact of the LIFE program on weight gain restriction during pregnancy and postpartum weight loss in obese women in comparison to the RC group.
To examine the impact of the LIFE program on short- and long-term maternal and offspring outcomes at study enrollment, 34-36 weeks gestation and 3 months postpartum in obese women in comparison to the RC group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnancy; Obesity; Weight gain; Obstetric complications; Lifestyle intervention