Lifestyle Intervention Forever: Healthy Weight for Pregnancy and Birth (Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Measurement of Gestational weight gain from study entry to delivery
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Measurement of Gestational weight gain from study entry to delivery
时间窗: Approx. 20-25 weeks
Maternal weight (lb) will be measured at program entry and at the time of delivery to determine weight gain during the study period. Pre-pregnancy body weight will be self-reported and used to estimate total gestational weight gain (lb).
次要结局
- Measure Change from baseline in maternal aerobic capacity(16-21 weeks)
- Measure Maternal hormonal/metabolic changes from baseline(16-21 weeks)
- Number of participants with Obstetric complications(1-25 weeks)
- Change from baseline in maternal dietary intake(16-21 weeks)
- Measure Change from baseline in maternal psychometric outcomes(16-21 weeks)
- Measure Offspring - fetal growth(10-25 weeks)
- Measure Change from baseline in maternal body composition(16-21 weeks)
- Measure Offspring metabolic markers(20-25 weeks)
- Measure Pilot study outcomes(32-37 weeks)
- Measure Postpartum weight retention at 12 weeks postpartum(12 weeks)
- Measure Change from baseline in maternal physical activity levels(16-21 weeks)
- Measure Infant size at 12 weeks of age(12 weeks)
- Measure Infant body composition at 12 weeks of age(12 weeks)
- Measure Neonatal size at birth(Within 48 hours of birth)
- Measure Neonatal body composition at birth(Within 48 hours of birth)
研究者
Rosemary Catanzaro, RD
Registered Dietician
St. Louis University