Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)
2018年10月13日 更新者:Linda Van Horn、Northwestern University
Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)
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.
研究概览
详细说明
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
研究类型
介入性
注册 (实际的)
281
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Illinois
-
Chicago、Illinois、美国、60611
- Northwestern Memorial Hospital; Prentice Women's
-
Chicago、Illinois、美国、60611
- Northwestern University: Dept of Preventive Medicine
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 45年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器: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.
|
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.
|
|
实验性的: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
|
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
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Gestational Weight Gain (GWG)
大体时间: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.
|
14-37 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants With Gestational Diabetes
大体时间:24-26 weeks
|
Oral Glucose Tolerance Test (OGTT) will be administered at 24-26wks, as part of routine obstetric visit.
Difference in incidence of Gestational diabetes between study groups will be documented.
|
24-26 weeks
|
|
Fasting Glucose
大体时间:14-37 wks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 wks
|
|
High-density Lipoprotein (HDL)
大体时间:14-37 wks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 wks
|
|
Low-density Lipoprotein (LDL)
大体时间:14-37 weeks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 weeks
|
|
Total Cholesterol
大体时间:14-37 Weeks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 Weeks
|
|
Triglycerides
大体时间:14-37 Weeks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 Weeks
|
|
Leptin
大体时间:14-37 weeks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 weeks
|
|
Steady State Beta Cell Function
大体时间:baseline (14 weeks) and 35-37 weeks
|
Insulin resistance will be measured with the assistance of a computer program (HOMA Calculator v2.2.3, Diabetic Trial Unit, University of Oxford) which uses blood Glucose and Insulin measures to yield the Homeostatic Model Assessment (HOMA) Steady State beta cell function (%B).
100% is set at normal reference.
Should not be interpreted alone, but in combination with Insulin Sensitivity (%S).
|
baseline (14 weeks) and 35-37 weeks
|
|
Insulin Sensitivity
大体时间:baseline(14 weeks) and 35-37 weeks
|
Insulin resistance will be measured with the assistance of a computer program which will yield the Homeostatic Model Assessment (HOMA) Insulin Sensitivity (%S).
100% is equivalent to the normal reference, but needs to be interpreted in context of %B.
|
baseline(14 weeks) and 35-37 weeks
|
|
Insulin Resistance (IR)
大体时间:Baseline (14 weeks) and 35 weeks
|
Insulin resistance will be measured with the assistance of a computer program (HOMA Calculator v2.2.3, Diabetic Trial Unit, University of Oxford) which uses blood Glucose and Insulin measures to yield the Homeostatic Model Assessment (HOMA) Insulin Resistance. HOMA IR (insulin resistance) is the reciprocal of insulin sensitivity (%S), as a percentage of a normal reference population (100/%S); Lower IR is better. Note: estimates are model-derived, and not linear approximations. |
Baseline (14 weeks) and 35 weeks
|
|
Birth Weight
大体时间:Delivery
|
Neonatal Body measurements
|
Delivery
|
|
Birth Length
大体时间:Delivery
|
Neonate birth measures
|
Delivery
|
|
Head Circumference
大体时间:Delivery
|
Neonate birth measures
|
Delivery
|
|
Neonate Percent Body Fat
大体时间:Delivery
|
Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system.
|
Delivery
|
|
Infant Weight
大体时间:1 year
|
Infant Body measurements
|
1 year
|
|
Infant Length
大体时间:1 year
|
Infant body measurement
|
1 year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Linda V Van Horn, PhD、Northwestern University
- 首席研究员:Alan Peaceman, MD、Northwestern Memorial Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Redman LM, Drews KL, Klein S, Horn LV, Wing RR, Pi-Sunyer X, Evans M, Joshipura K, Arteaga SS, Cahill AG, Clifton RG, Couch KA, Franks PW, Gallagher D, Haire-Joshu D, Martin CK, Peaceman AM, Phelan S, Thom EA, Yanovski SZ, Knowler WC; LIFE-Moms Research Group. Attenuated early pregnancy weight gain by prenatal lifestyle interventions does not prevent gestational diabetes in the LIFE-Moms consortium. Diabetes Res Clin Pract. 2021 Jan;171:108549. doi: 10.1016/j.diabres.2020.108549. Epub 2020 Nov 22.
- Peaceman AM, Clifton RG, Phelan S, Gallagher D, Evans M, Redman LM, Knowler WC, Joshipura K, Haire-Joshu D, Yanovski SZ, Couch KA, Drews KL, Franks PW, Klein S, Martin CK, Pi-Sunyer X, Thom EA, Van Horn L, Wing RR, Cahill AG; LIFE-Moms Research Group. Lifestyle Interventions Limit Gestational Weight Gain in Women with Overweight or Obesity: LIFE-Moms Prospective Meta-Analysis. Obesity (Silver Spring). 2018 Sep;26(9):1396-1404. doi: 10.1002/oby.22250. Epub 2018 Sep 6.
- Clifton RG, Evans M, Cahill AG, Franks PW, Gallagher D, Phelan S, Pomeroy J, Redman LM, Van Horn L; LIFE-Moms Research Group. Design of lifestyle intervention trials to prevent excessive gestational weight gain in women with overweight or obesity. Obesity (Silver Spring). 2016 Feb;24(2):305-13. doi: 10.1002/oby.21330. Epub 2015 Dec 26.
- Van Horn L, Peaceman A, Kwasny M, Vincent E, Fought A, Josefson J, Spring B, Neff LM, Gernhofer N. Dietary Approaches to Stop Hypertension Diet and Activity to Limit Gestational Weight: Maternal Offspring Metabolics Family Intervention Trial, a Technology Enhanced Randomized Trial. Am J Prev Med. 2018 Nov;55(5):603-614. doi: 10.1016/j.amepre.2018.06.015. Epub 2018 Sep 24.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年11月1日
初级完成 (实际的)
2017年7月31日
研究完成 (实际的)
2017年7月31日
研究注册日期
首次提交
2012年6月25日
首先提交符合 QC 标准的
2012年6月27日
首次发布 (估计)
2012年6月29日
研究记录更新
最后更新发布 (实际的)
2018年11月6日
上次提交的符合 QC 标准的更新
2018年10月13日
最后验证
2018年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.