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Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01631747
First Posted: June 29, 2012
Last Update Posted: August 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Linda Van Horn, Northwestern University
June 25, 2012
June 29, 2012
August 15, 2017
November 2012
July 31, 2017   (Final data collection date for primary outcome measure)
Gestational Weight Gain (GWG) [ Time Frame: 14-36 weeks ]
The primary outcome is GWG as assessed continuously by the difference between the maternal weight measured at the baseline and at the 36 week visit.
Gestational Weight Gain (GWG) [ Time Frame: 14-36 weeks ]
The primary outcome is GWG as assessed continuously by the difference between the maternal weight measured at the 36 week visit and the self-reported pre-pregnancy weight
Complete list of historical versions of study NCT01631747 on ClinicalTrials.gov Archive Site
  • Gestational Diabetes [ Time Frame: up to 40 weeks ]
    OGTT will be administered at 24-26wks,as part of routine OB visit. Difference in incidence of Gestational diabetes between study groups will be documented.
  • Diet and metabolomic assessment [ Time Frame: 14-37 wks ]
    Blood will be collected at Baseline, 24-26weeks,and 35-37weeks. Fasting glucose, lipids, C-reactive protein, vitamin D, leptin, adiponectin will be measured and observed for change.
  • Insulin Resistance [ Time Frame: up to 40 weeks ]
    Insulin resistance will be measured with the assistance of a computer program which will yield the Homeostatic Model Assessment (HOMA)Score
  • Neonatal Body measurements [ Time Frame: up to 40 weeks ]
    The following measures will be assessed at birth: weight, length,head circumference and %body fat as measured by PEAPOD
  • Infant Body measurements [ Time Frame: 1 year ]
    These following measurements will be assessed at one year of age for comparison to measurements at birth: weight,length and head circumference
  • Maternal Secondary Outcomes [ Time Frame: up to 40 weeks ]
    1. gestational diabetes
    2. preeclampsia
    3. cesarean delivery
    4. shoulder dystocia
    5. weight, adiposity, BP, fasting glucose, lipids, C-reactive protein, vitamin D, leptin, adiponectin
    6. Homeostatic Model Assessment (HOMA) score, a measure of insulin resistance (with the assistance of a computer program available online from the University of Oxford Diabetes Trial Unit)
    7. diet quality (diet and metabolomics assessment)
    8. physical activity
    9. sleep quality and duration
    10. measures of stress and self-efficacy
  • Fetal and Neonatal Secondary Outcomes [ Time Frame: 40 weeks ]
    1. birth weight
    2. newborn length
    3. % body fat measured by ADP
  • Infant Secondary Outcomes [ Time Frame: 1 year ]
    1. weight
    2. length
    3. head circumference
Not Provided
Not Provided
 
Maternal-Offspring Metabolics:Family Intervention Trial
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.
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 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 Calorie King software 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 BMI and adiposity postpartum, blood pressure, blood glucose, insulin, HbA1c, CRP, and lipids, diet quality, and physical activity levels, offspring adiposity and anthropometrics, and glucose and C-peptide in cord blood
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Pregnancy
  • Weight Gain
  • 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
  • Behavioral: 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.
  • Active Comparator: 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.
    Intervention: Behavioral: Usual Care Group
  • Experimental: 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
    Intervention: Behavioral: Lifestyle Intervention Group
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
281
July 31, 2017
July 31, 2017   (Final data collection date for primary outcome measure)

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 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:

  • 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
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01631747
DK10-014
1U01HL114344-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Linda Van Horn, Northwestern University
Northwestern University
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Linda V Van Horn, PhD Northwestern University
Principal Investigator: Alan Peaceman, MD Northwestern Memorial Hospital
Northwestern University
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP