- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01631747
Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)
Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital; Prentice Women's
-
Chicago, Illinois, United States, 60611
- Northwestern University: Dept of Preventive Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
14-37 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24-26 weeks
|
Fasting Glucose
Time Frame: 14-37 wks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 wks
|
High-density Lipoprotein (HDL)
Time Frame: 14-37 wks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 wks
|
Low-density Lipoprotein (LDL)
Time Frame: 14-37 weeks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 weeks
|
Total Cholesterol
Time Frame: 14-37 Weeks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 Weeks
|
Triglycerides
Time Frame: 14-37 Weeks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 Weeks
|
Leptin
Time Frame: 14-37 weeks
|
Blood will be collected at Baseline and 35-37 weeks.
|
14-37 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).
|
baseline (14 weeks) and 35-37 weeks
|
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.
|
baseline(14 weeks) and 35-37 weeks
|
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. |
Baseline (14 weeks) and 35 weeks
|
Birth Weight
Time Frame: Delivery
|
Neonatal Body measurements
|
Delivery
|
Birth Length
Time Frame: Delivery
|
Neonate birth measures
|
Delivery
|
Head Circumference
Time Frame: Delivery
|
Neonate birth measures
|
Delivery
|
Neonate Percent Body Fat
Time Frame: Delivery
|
Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system.
|
Delivery
|
Infant Weight
Time Frame: 1 year
|
Infant Body measurements
|
1 year
|
Infant Length
Time Frame: 1 year
|
Infant body measurement
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Linda V Van Horn, PhD, Northwestern University
- Principal Investigator: Alan Peaceman, MD, Northwestern Memorial Hospital
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK10-014
- 1U01HL114344-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnancy
-
Far Eastern Memorial HospitalCompletedCornual PregnancyTaiwan
-
Peking Union Medical College HospitalPeking Union Medical CollegeUnknownPregnancy | Pregnancy Related | Infant | Pregnancy Disease | Risk FactorChina
-
Ufuk UniversityNot yet recruitingPregnancy Complications | Pregnancy Loss | Pregnancy Preterm
-
Hadassah Medical OrganizationCompleted
-
Centre Hospitalier Universitaire de Saint EtienneCompletedProlonged PregnancyFrance
-
University Hospital, ToursCompleted
-
Turku University HospitalUniversity of TurkuCompleted
-
Technische Universität DresdenWithdrawnPregnancy Trimester, Second | Pregnancy Trimester, First | Pregnancy Trimester, ThirdGermany
-
Universitair Ziekenhuis BrusselMerck Serono International SAUnknownPregnancy | Pregnancy LossBelgium
-
Hopital Antoine BeclereUnknown
Clinical Trials on Usual Care Group
-
Johns Hopkins UniversityJohns Hopkins Alliance for a Healthier WorldActive, not recruiting
-
Neuromed IRCCSRecruitingMigraine | Chronic Migraine | Episodic Migraine | Musculoskeletal Neck Pain | Musculoskeletal Disorder of the NeckItaly
-
Instituto de Investigacion Sanitaria La FeCompleted
-
Massachusetts General HospitalConquer Cancer FoundationCompletedAnxiety | Caregiver Burden | Malignant Glioma | Malignant Brain TumorUnited States
-
Mayo ClinicWithdrawnPhysical Activity | Blood Markers | Cardiac Rehab
-
Icahn School of Medicine at Mount SinaiNational Cancer Institute (NCI)Completed
-
Pontificia Universidad Catolica de ChileComisión Nacional de Investigación Científica y TecnológicaCompletedChild Development | Mother-Child RelationsChile
-
IR Technology, LLCCompletedObesity | Body Weight | Cellulite | Fat Burn | Abdominal Fat | Adipose Tissue AtrophyUnited States
-
Community Health Center of Franklin CountyMassachusetts General Hospital; Just RootsUnknown
-
Norwegian University of Science and TechnologyTerminated