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Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Northwestern University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Linda Van Horn, Northwestern University
ClinicalTrials.gov Identifier:
NCT01631747
First received: June 25, 2012
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Pregnancy
Weight Gain
Behavioral: Lifestyle Intervention Group
Behavioral: Usual Care Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Gestational Weight Gain (GWG) [ Time Frame: 14-36 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Gestational Diabetes [ Time Frame: up to 40 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    These following measurements will be assessed at one year of age for comparison to measurements at birth: weight,length and head circumference


Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631747

Contacts
Contact: Niki A Gernhofer, MS 312-908-9321 n-gernhofer@northwestern.edu
Contact: Linda V Van Horn, PhD 312-908-8938 lvanhorn@northwestern.edu

Locations
United States, Illinois
Northwestern Memorial Hospital; Prentice Women's Recruiting
Chicago, Illinois, United States, 60611
Contact: Niki A Gernhofer, MS    312-908-9321    n-gernhofer@northwestern.edu   
Principal Investigator: Alan Peaceman, MD         
Northwestern University: Dept of Preventive Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Niki A Gernhofer, MS    312-908-9321    n-gernhofer@northwestern.edu   
Principal Investigator: Linda V Van Horn, PhD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Linda V Van Horn, PhD Northwestern University
Principal Investigator: Alan Peaceman, MD Northwestern Memorial Hospital
  More Information

No publications provided

Responsible Party: Linda Van Horn, Professor, Preventive Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01631747     History of Changes
Other Study ID Numbers: DK10-014, 1U01HL114344-01
Study First Received: June 25, 2012
Last Updated: August 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Pregnancy
Weight gain
Obesity
Pregnancy and weight gain

Additional relevant MeSH terms:
Weight Gain
Body Weight
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014