Maternal-Offspring Metabolics:Family Intervention Trial
MOMFIT
2 other identifiers
interventional
281
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pregnancy
Started Nov 2012
Longer than P75 for not_applicable pregnancy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2012
CompletedFirst Posted
Study publicly available on registry
June 29, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2017
CompletedResults Posted
Study results publicly available
September 25, 2018
CompletedNovember 6, 2018
October 1, 2018
4.7 years
June 25, 2012
July 26, 2018
October 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gestational Weight Gain (GWG)
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
Secondary Outcomes (16)
Percentage of Participants With Gestational Diabetes
24-26 weeks
Fasting Glucose
14-37 wks
High-density Lipoprotein (HDL)
14-37 wks
Low-density Lipoprotein (LDL)
14-37 weeks
Total Cholesterol
14-37 Weeks
- +11 more secondary outcomes
Study Arms (2)
Usual Care Group
ACTIVE COMPARATORMom 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.
Lifestyle Intervention Group
EXPERIMENTALWomen 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
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- National Institutes of Health (NIH)collaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (2)
Northwestern Memorial Hospital; Prentice Women's
Chicago, Illinois, 60611, United States
Northwestern University: Dept of Preventive Medicine
Chicago, Illinois, 60611, United States
Related Publications (6)
Cabre HE, Drews KL, Pomeroy J, Keadle SK, Arteaga SS, Franks PW, Haire-Joshu D, Knowler WC, Pi-Sunyer X, Van Horn L, Wing RR, Cahill AG, Clifton RG, Couch KA, Gallager D, Josefson JL, Joshipura K, Klein S, Martin CK, Peaceman AM, Phelan S, Thom EA, Redman LM; LIFE-Moms Research Group. LIFE-Moms: effects of multicomponent lifestyle randomized control trial on physical activity during pregnancy in women with overweight and obesity. Int J Behav Nutr Phys Act. 2025 Sep 30;22(1):119. doi: 10.1186/s12966-025-01805-9.
PMID: 41029405DERIVEDFlanagan EW, Drews KL, Cade WT, Franks PW, Gallagher D, Phelan S, Van Horn L, Redman LM. Metabolic Health and Heterogenous Outcomes of Prenatal Interventions: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2528264. doi: 10.1001/jamanetworkopen.2025.28264.
PMID: 40839263DERIVEDRedman 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.
PMID: 33238176DERIVEDVan 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.
PMID: 30262148DERIVEDPeaceman 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.
PMID: 30230252DERIVEDClifton 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.
PMID: 26708836DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study recruited 281 participants, fewer than the target sample size of 300; this did not impact power for the primary outcome (higher retention rates), but requires attention when considering translational implications to a clinic setting.
Results Point of Contact
- Title
- Mary J. Kwasny
- Organization
- Northwestern University
Study Officials
- PRINCIPAL INVESTIGATOR
Linda V Van Horn, PhD
Northwestern University
- PRINCIPAL INVESTIGATOR
Alan Peaceman, MD
Northwestern Memorial Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Preventive Medicine
Study Record Dates
First Submitted
June 25, 2012
First Posted
June 29, 2012
Study Start
November 1, 2012
Primary Completion
July 31, 2017
Study Completion
July 31, 2017
Last Updated
November 6, 2018
Results First Posted
September 25, 2018
Record last verified: 2018-10