Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)
![]() |
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. |
ClinicalTrials.gov Identifier: NCT01631747 |
Recruitment Status :
Completed
First Posted : June 29, 2012
Results First Posted : September 25, 2018
Last Update Posted : November 6, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pregnancy Weight Gain | Behavioral: Lifestyle Intervention Group Behavioral: Usual Care Group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 281 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT) |
Study Start Date : | November 2012 |
Actual Primary Completion Date : | July 31, 2017 |
Actual Study Completion Date : | July 31, 2017 |
Arm | Intervention/treatment |
---|---|
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
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 |
- Gestational Weight Gain (GWG) [ Time Frame: 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.
- Percentage of Participants With Gestational Diabetes [ Time Frame: 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.
- Fasting Glucose [ Time Frame: 14-37 wks ]Blood will be collected at Baseline and 35-37 weeks.
- High-density Lipoprotein (HDL) [ Time Frame: 14-37 wks ]Blood will be collected at Baseline and 35-37 weeks.
- Low-density Lipoprotein (LDL) [ Time Frame: 14-37 weeks ]Blood will be collected at Baseline and 35-37 weeks.
- Total Cholesterol [ Time Frame: 14-37 Weeks ]Blood will be collected at Baseline and 35-37 weeks.
- Triglycerides [ Time Frame: 14-37 Weeks ]Blood will be collected at Baseline and 35-37 weeks.
- Leptin [ Time Frame: 14-37 weeks ]Blood will be collected at Baseline and 35-37 weeks.
- Steady State Beta Cell Function [ Time Frame: 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).
- Insulin Sensitivity [ Time Frame: 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.
- Insulin Resistance (IR) [ Time Frame: 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.
- Birth Weight [ Time Frame: Delivery ]Neonatal Body measurements
- Birth Length [ Time Frame: Delivery ]Neonate birth measures
- Head Circumference [ Time Frame: Delivery ]Neonate birth measures
- Neonate Percent Body Fat [ Time Frame: Delivery ]Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system.
- Infant Weight [ Time Frame: 1 year ]Infant Body measurements
- Infant Length [ Time Frame: 1 year ]Infant body measurement

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631747
United States, Illinois | |
Northwestern Memorial Hospital; Prentice Women's | |
Chicago, Illinois, United States, 60611 | |
Northwestern University: Dept of Preventive Medicine | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Linda V Van Horn, PhD | Northwestern University | |
Principal Investigator: | Alan Peaceman, MD | Northwestern Memorial Hospital |
Documents provided by Linda Van Horn, Northwestern University:
Responsible Party: | Linda Van Horn, Professor, Preventive Medicine, Northwestern University |
ClinicalTrials.gov Identifier: | NCT01631747 |
Other Study ID Numbers: |
DK10-014 1U01HL114344-01 ( U.S. NIH Grant/Contract ) |
First Posted: | June 29, 2012 Key Record Dates |
Results First Posted: | September 25, 2018 |
Last Update Posted: | November 6, 2018 |
Last Verified: | October 2018 |
Pregnancy Weight gain Obesity Pregnancy and weight gain |
Weight Gain Body Weight Changes Body Weight |