Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 281
- 试验地点
- 4
- 主要终点
- Gestational Weight Gain (GWG)
研究概览
简要总结
The prevalence of maternal overweight and obesity has nearly doubled in the United States since 1976. In 2004-2005, 42% of pregnant women had body mass index (BMI) above 25 versus 23% in 1993. Most American women are overweight/ obese (OW/OB) at conception, especially within certain racial, ethnic, and lower socioeconomic groups leading to increased adverse maternal and birth outcomes. This study will recruit, randomize and test in 300 ethnically diverse OW/OB pregnant women a behavioral intervention aimed at controlling gestational weight gain (GWG) through recommended diet, activity and lifestyle changes that are to be maintained postpartum. Outcomes include anthropometric (height, weight, percent body fat) metabolic (blood pressure, fasting glucose, insulin, HbA1c, lipids and C-reactive protein) and behavioral measures (diet. physical activity, sleep and stress). In addition, babies will be measured for length, weight and percent body fat. The goal is to limit excessive gestational weight gain through improved maternal lifestyle that can be maintained and modelled for the family post partum and beyond.
详细描述
A Randomized Control Trial is planned among ethnically diverse OW/OB pregnant women ages 18-45 years to be randomly assigned to the MOMFIT Active Intervention Group (AIG) or the Educational Control Group (ECG) plus standard obstetrical care. The Dietary Approaches to Stop Hypertension (DASH) diet, along with moderate physical activity and group intervention as utilized in the Diabetes Prevention Program (DPP), will be adapted for pregnant and postpartum women through individual visits to tailor calorie/nutrient/activity goals, plus group coaching sessions and electronic self-monitoring behavior. Evidence based motivational interviewing and state of the art self-monitoring tools involving the LoseIt app will be adapted for pregnant/postpartum women via smartphone or Internet access, along with tailored feedback and encouragement from the Lifestyle Coach. Prevention of excessive GWG and achievement of the Institute Of Medicine (IOM) weight gain goals will be compared between groups, whether ongoing adherence to the lifestyle interventions can be sustained through postpartum intervention. Approximately one third of the participants are expected to be minorities and/or from low income backgrounds. The primary outcome is gestational weight gain from baseline (self-reported prepregnancy weight) to near delivery (36 weeks) compared with IOM goals in both groups and postpartum weight retention between 6 weeks and 12 months postpartum. Additional outcome variables include changes in maternal Body Mass Index (BMI) and adiposity postpartum, blood pressure, blood glucose, insulin, Hemoglobin A1c (HbA1c), C-reactive Protein (CRP), and lipids, diet quality, and physical activity levels, offspring adiposity and anthropometrics, and glucose and C-peptide in cord blood
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-45 years
- •Singleton viable pregnancy. A twin pregnancy reduced to singleton before 14 weeks by project gestational age. 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 (see Section 3.4.3 below) that compares the last menstrual period (LMP) date and data from the earliest ultrasound
- •Body mass index between 25-35 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.
排除标准
- •In vitro fertilization (IVF) conception/ovulation induction w/ gonadotropins
- •Weight gain of >15 pounds from reported prepregnancy weight to Baseline visit
- •Current smoker
- •Prior bariatric surgery
- •In weight loss program w/in 3 months of conception
- •History of alcohol or drug abuse within 5 years
- •No access to internet and/or smartphone
- •Unable to attend intervention/follow-up visits
- •Unwilling/unable to commit to self-monitoring data collection
- •Unable to complete intervention program
- •Presence of any condition that limits walking or following diet recommendations
- •Not fluent in English
研究组 & 干预措施
Usual Care Group
Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics.
干预措施: Usual Care Group (Behavioral)
Lifestyle Intervention Group
Women in the Intervention group will participate in a lifestyle program based on Moms'adopting a healthier diet and becoming more active for 24 months. Implementation is at approximately 15 weeks.Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer
干预措施: Lifestyle Intervention Group (Behavioral)
结局指标
主要结局
Gestational Weight Gain (GWG)
时间窗: 14-37 weeks
The primary outcome is GWG as assessed continuously by the difference between the maternal weight measured at the baseline and at the 35-37 week visit.
次要结局
- Steady State Beta Cell Function(baseline (14 weeks) and 35-37 weeks)
- Insulin Resistance (IR)(Baseline (14 weeks) and 35 weeks)
- Birth Length(Delivery)
- Percentage of Participants With Gestational Diabetes(24-26 weeks)
- Fasting Glucose(14-37 wks)
- Low-density Lipoprotein (LDL)(14-37 weeks)
- Leptin(14-37 weeks)
- Head Circumference(Delivery)
- Birth Weight(Delivery)
- Neonate Percent Body Fat(Delivery)
- High-density Lipoprotein (HDL)(14-37 wks)
- Infant Weight(1 year)
- Total Cholesterol(14-37 Weeks)
- Triglycerides(14-37 Weeks)
- Insulin Sensitivity(baseline(14 weeks) and 35-37 weeks)
- Infant Length(1 year)
研究者
Linda Van Horn
Professor, Preventive Medicine
Northwestern University