Clinical trial NCT01693666: Lifestyle Intervention Forever: Healthy Weight for Pregnancy and Birth (Pilot Study)
Official title: Lifestyle Intervention Forever: Healthy Weight for Pregnancy and Birth (Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Obesity
Weight Gain
Obstetric Complications
Keywords: Pregnancy
Obesity
Weight gain
Obstetric complications
Lifestyle intervention
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Women aged 18-40 years with a confirmed singleton pregnancy of up to 18 weeks gestation
* Pre-pregnancy or early pregnancy BMI greater than or equal to 30 kg/m2

Exclusion Criteria:

* Aged \< 18 years or \> 40 years
* BMI \< 30 kg/m2 at study screening
* Multiple gestations
* Previously diagnosed with type 1 or type 2 diabetes mellitus
* Subjects will be excluded from the study if they present with any absolute or relative contraindications to exercise in pregnancy (as defined by ACOG); determined by completion of medical questionnaire by supervising physician
* Any evidence of:

  i. Drug or alcohol abuse ii. Presence of any unstable psychiatric disorder iii. Plans to move away from the geographical area within the next nine months iv. Other medical or behavioral factors that, in the judgement of the supervising physician, may interfere with their ability to take part in a lifestyle intervention program during pregnancy.

Primary outcomes:
measure: Measurement of Gestational weight gain from study entry to delivery
timeFrame: Approx. 20-25 weeks
Secondary outcomes:
measure: Measure Change from baseline in maternal body composition
timeFrame: 16-21 weeks
measure: Measure Change from baseline in maternal aerobic capacity
timeFrame: 16-21 weeks
measure: Measure Maternal hormonal/metabolic changes from baseline
timeFrame: 16-21 weeks
measure: Number of participants with Obstetric complications
timeFrame: 1-25 weeks
measure: Change from baseline in maternal dietary intake
timeFrame: 16-21 weeks
measure: Measure Change from baseline in maternal psychometric outcomes
timeFrame: 16-21 weeks
measure: Measure Offspring - fetal growth
timeFrame: 10-25 weeks
measure: Measure Neonatal size at birth
timeFrame: Within 48 hours of birth
measure: Measure Neonatal body composition at birth
timeFrame: Within 48 hours of birth
measure: Measure Offspring metabolic markers
timeFrame: 20-25 weeks
measure: Measure Pilot study outcomes
timeFrame: 32-37 weeks
measure: Measure Postpartum weight retention at 12 weeks postpartum
timeFrame: 12 weeks
measure: Measure Change from baseline in maternal physical activity levels
timeFrame: 16-21 weeks
measure: Measure Infant size at 12 weeks of age
timeFrame: 12 weeks
measure: Measure Infant body composition at 12 weeks of age
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: St. Louis University
name: Rosemary Catanzaro
role: PRINCIPAL_INVESTIGATOR
References: