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CompletedNCT01631747MOMFITUpdated Nov 6, 2018Results posted

Maternal-Offspring Metabolics:Family Intervention Trial

An interventional study of Lifestyle Intervention Group and Usual Care Group in Pregnancy and Weight Gain, sponsored by Northwestern University. Completed at 2 sites in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-11-06.

Sponsored by Northwestern University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
281
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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 Dietary Approaches to Stop Hypertension (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 LoseIt app 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 Body Mass Index (BMI) and adiposity postpartum, blood pressure, blood glucose, insulin, Hemoglobin A1c (HbA1c), C-reactive Protein (CRP), and lipids, diet quality, and physical activity levels, offspring adiposity and anthropometrics, and glucose and C-peptide in cord blood

02

Conditions studied

  • Pregnancy
  • Weight Gain

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Keywords

  • Pregnancy
  • Weight gain
  • Obesity
  • Pregnancy and weight gain
03

In context

Weight Gain

405 studies on the registry are indexed under Weight Gain; 52 are open to participants now.

This study's enrollment of 281 is above the median of 83 across 324 interventional studies indexed under Weight Gain.

Browse Weight Gain studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
281 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralLifestyle 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

  • BehavioralUsual 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.

06

What researchers measure

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.

    Time frame: 14-37 weeks

Secondary outcomes

  1. Percentage of Participants With Gestational Diabetes

    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.

    Time frame: 24-26 weeks

  2. Fasting Glucose

    Blood will be collected at Baseline and 35-37 weeks.

    Time frame: 14-37 wks

  3. High-density Lipoprotein (HDL)

    Blood will be collected at Baseline and 35-37 weeks.

    Time frame: 14-37 wks

  4. Low-density Lipoprotein (LDL)

    Blood will be collected at Baseline and 35-37 weeks.

    Time frame: 14-37 weeks

  5. Total Cholesterol

    Blood will be collected at Baseline and 35-37 weeks.

    Time frame: 14-37 Weeks

  6. Triglycerides

    Blood will be collected at Baseline and 35-37 weeks.

    Time frame: 14-37 Weeks

  7. Leptin

    Blood will be collected at Baseline and 35-37 weeks.

    Time frame: 14-37 weeks

  8. Steady State Beta Cell Function

    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).

    Time frame: baseline (14 weeks) and 35-37 weeks

  9. Insulin Sensitivity

    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.

    Time frame: baseline(14 weeks) and 35-37 weeks

  10. Insulin Resistance (IR)

    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.

    Time frame: Baseline (14 weeks) and 35 weeks

  11. Birth Weight

    Neonatal Body measurements

    Time frame: Delivery

  12. Birth Length

    Neonate birth measures

    Time frame: Delivery

  13. Head Circumference

    Neonate birth measures

    Time frame: Delivery

  14. Neonate Percent Body Fat

    Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system.

    Time frame: Delivery

  15. Infant Weight

    Infant Body measurements

    Time frame: 1 year

  16. Infant Length

    Infant body measurement

    Time frame: 1 year

07

Results

Posted Sep 25, 2018
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.

Participant flow

Women were screened from multiple practices at the Prentice Women's Hospital of Northwestern Memorial Hospital. Screening took place between Feb 2013-Dec 2015.

Randomization Through End of Pregnancy
Participant flow — Randomization Through End of Pregnancy
MilestoneUsual Care GroupLifestyle Intervention Group
Started141140
Completed140140
Not completed10
Withdrew: Lost to follow-up10
Live Birth
Participant flow — Live Birth
MilestoneUsual Care GroupLifestyle Intervention Group
Started140140
Completed136139
Not completed41
Withdrew: Pregnancy termination10
Withdrew: Miscarriage20
Withdrew: Stillbirth11
One Year Infant Outcomes
Participant flow — One Year Infant Outcomes
MilestoneUsual Care GroupLifestyle Intervention Group
Started136139
Completed123130
Not completed139
Withdrew: Patient refused139

Outcome measures

PrimaryGestational 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.

Time frame:
14-37 weeks
Reported as:
Mean · kg
Gestational Weight Gain (GWG)
kgUsual Care GroupLifestyle Intervention Group
Gestational Weight Gain (GWG)12 ± 610 ± 6
Statistical analysis
  • Usual Care Group vs Lifestyle Intervention Group · t-test, 2 sided · p = 0.01 (p-value is not adjusted for multiple comparisons, and tested at an a priori type I error rate of 0.05.)
  • Usual Care Group vs Lifestyle Intervention Group · Regression, Linear · p = 0.02adjusted for actual gestational age of 36 week weight, gestational age, bmi, and maternal age at randomization, maternal race and paternal race.
SecondaryPercentage of Participants With Gestational Diabetes

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.

Time frame:
24-26 weeks
Reported as:
Count of participants · Participants
Percentage of Participants With Gestational Diabetes
ParticipantsUsual Care GroupLifestyle Intervention Group
Percentage of Participants With Gestational Diabetes97
Statistical analysis
  • Usual Care Group vs Lifestyle Intervention Group · Chi-squared · p = 0.54
SecondaryFasting Glucose

Blood will be collected at Baseline and 35-37 weeks.

Time frame:
14-37 wks
Reported as:
Median · mg/dL
Fasting Glucose
mg/dLUsual Care GroupLifestyle Intervention Group
Baseline87 (83 to 91)86 (82 to 90)
35-37 Weeks85 (81 to 89)84 (80 to 89)
Statistical analysis
  • Usual Care Group vs Lifestyle Intervention Group · t-test, 2 sided · p = 0.89T-test performed on change in glucose (log scale), but presented as Median and inter-quartile range for interpretability
SecondaryHigh-density Lipoprotein (HDL)

Blood will be collected at Baseline and 35-37 weeks.

Time frame:
14-37 wks
Reported as:
Median · mg/dL
High-density Lipoprotein (HDL)
mg/dLUsual Care GroupLifestyle Intervention Group
Baseline66 (58 to 78)71 (60 to 80)
35-37 Weeks68 (57 to 79)70 (56 to 82)
Statistical analysis
  • Usual Care Group vs Lifestyle Intervention Group · t-test, 2 sided · p = 0.30t-test performed on changes in HDL, but presented as median and IQR for ease of interpretation
SecondaryLow-density Lipoprotein (LDL)

Blood will be collected at Baseline and 35-37 weeks.

Time frame:
14-37 weeks
Reported as:
Median · mg/dL
Low-density Lipoprotein (LDL)
mg/dLUsual Care GroupLifestyle Intervention Group
Baseline95 (79 to 112)94 (78 to 117)
35-37 Weeks146 (103 to 164)130 (106 to 163)
Statistical analysis
  • Usual Care Group vs Lifestyle Intervention Group · t-test, 2 sided · p = 0.69t-test run on changes between groups. Data presented as median and IQR for ease of interpretation
SecondaryTotal Cholesterol

Blood will be collected at Baseline and 35-37 weeks.

Time frame:
14-37 Weeks
Reported as:
Median · mg/dL
Total Cholesterol
mg/dLUsual Care GroupLifestyle Intervention Group
Baseline188 (167 to 205)185 (164 to 208)
35-37 Weeks255 (219 to 290)252 (222 to 281)
Statistical analysis
  • Usual Care Group vs Lifestyle Intervention Group · t-test, 2 sided · p = 0.19t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation
SecondaryTriglycerides

Blood will be collected at Baseline and 35-37 weeks.

Time frame:
14-37 Weeks
Reported as:
Median · mg/dL
Triglycerides
mg/dLUsual Care GroupLifestyle Intervention Group
Baseline108 (86 to 138)109 (81 to 131)
35-37 Weeks235 (187 to 300)223 (180 to 271)
Statistical analysis
  • Usual Care Group vs Lifestyle Intervention Group · t-test, 2 sided · p = 0.27t-test used to compare changes between groups (log scale). Median and IQR are presented for ease of interpretation.
SecondaryLeptin

Blood will be collected at Baseline and 35-37 weeks.

Time frame:
14-37 weeks
Reported as:
Median · ug/L
Leptin
ug/LUsual Care GroupLifestyle Intervention Group
Baseline49 (40 to 58)50 (40 to 61)
35-37 Weeks59 (49 to 68)54 (44 to 67)
Statistical analysis
  • Usual Care Group vs Lifestyle Intervention Group · t-test, 2 sided · p = 0.003t-test performed on changes between groups (log scale). Median and IQR are presented for ease of interpretation
SecondarySteady State Beta Cell Function

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).

Time frame:
baseline (14 weeks) and 35-37 weeks
Reported as:
Median · percentage of normal reference
Steady State Beta Cell Function
percentage of normal referenceUsual Care GroupLifestyle Intervention Group
Baseline120 (99 to 150)121 (98 to 145)
35-37 Weeks174 (137 to 205)159 (133 to 195)
Statistical analysis
  • Usual Care Group · t-test, 2 sided · p = 0.24t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation
SecondaryInsulin Sensitivity

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.

Time frame:
baseline(14 weeks) and 35-37 weeks
Reported as:
Median · percentage of normal reference
Insulin Sensitivity
percentage of normal referenceUsual Care GroupLifestyle Intervention Group
Baseline78 (56 to 107)87 (59 to 112)
35-37 Weeks51 (39 to 74)62 (41 to 80)
Statistical analysis
  • Usual Care Group vs Lifestyle Intervention Group · t-test, 2 sided · p = 0.32t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation
SecondaryInsulin Resistance (IR)

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.

Time frame:
Baseline (14 weeks) and 35 weeks
Reported as:
Median · inverse proportion of normal reference
Insulin Resistance (IR)
inverse proportion of normal referenceUsual Care GroupLifestyle Intervention Group
Baseline1.3 (0.9 to 1.8)1.2 (0.9 to 1.7)
35-37 Weeks2.0 (1.4 to 2.6)1.6 (1.3 to 2.4)
Statistical analysis
  • Usual Care Group vs Lifestyle Intervention Group · t-test, 2 sided · p = 0.26T-test performed on change between groups (log scale). Median and IQR are presented for ease of interpretation
SecondaryBirth Weight

Neonatal Body measurements

Time frame:
Delivery
Reported as:
Mean · g
Birth Weight
gUsual Care GroupLifestyle Intervention Group
Birth Weight3213 ± 5243244 ± 489
Statistical analysis
  • Usual Care Group vs Lifestyle Intervention Group · t-test, 2 sided · p = 0.62
SecondaryBirth Length

Neonate birth measures

Time frame:
Delivery
Reported as:
Mean · cm
Birth Length
cmUsual Care GroupLifestyle Intervention Group
Birth Length51 ± 351 ± 2
Statistical analysis
  • Usual Care Group vs Lifestyle Intervention Group · t-test, 2 sided · p = 0.61
SecondaryHead Circumference

Neonate birth measures

Time frame:
Delivery
Reported as:
Mean · cm
Head Circumference
cmUsual Care GroupLifestyle Intervention Group
Head Circumference34 ± 234 ± 2
Statistical analysis
  • Usual Care Group vs Lifestyle Intervention Group · t-test, 2 sided · p = 0.42
SecondaryNeonate Percent Body Fat

Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system.

Time frame:
Delivery
Reported as:
Mean · percentage of weight
Neonate Percent Body Fat
percentage of weightUsual Care GroupLifestyle Intervention Group
Neonate Percent Body Fat11.9 ± 4.211.2 ± 4.4
Statistical analysis
  • Usual Care Group vs Lifestyle Intervention Group · t-test, 2 sided · p = 0.25
SecondaryInfant Weight

Infant Body measurements

Time frame:
1 year
Reported as:
Mean · kg
Infant Weight
kgUsual Care GroupLifestyle Intervention Group
Infant Weight9.9 ± 1.29.9 ± 1.3
Statistical analysis
  • Usual Care Group vs Lifestyle Intervention Group · t-test, 2 sided · p = 0.66
SecondaryInfant Length

Infant body measurement

Time frame:
1 year
Reported as:
Mean · cm
Infant Length
cmUsual Care GroupLifestyle Intervention Group
Infant Length76.3 ± 3.676.2 ± 3.5
Statistical analysis
  • Usual Care Group vs Lifestyle Intervention Group · t-test, 2 sided · p = 0.94

Adverse events

Collected over Each participant was followed from initial contact through delivery for adverse events (approximately 7 months).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Usual Care Group0/141 (0%)29/141 (20.6%)5/141 (3.5%)
Lifestyle Intervention Group0/140 (0%)18/140 (12.9%)3/140 (2.1%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventUsual Care GroupLifestyle Intervention Group
NICU admissionGeneral disorders18/14112/140
Congenital anomalyCongenital, familial and genetic disorders7/1412/140
PreeclampsiaPregnancy, puerperium and perinatal conditions6/1416/140
Pregnancy Loss/TerminationPregnancy, puerperium and perinatal conditions4/1411/140
CholestasisHepatobiliary disorders1/1411/140
Preterm laborPregnancy, puerperium and perinatal conditions1/1411/140
Vasa PreviaPregnancy, puerperium and perinatal conditions0/1411/140
RespiratoryRespiratory, thoracic and mediastinal disorders0/1411/140
AbruptionPregnancy, puerperium and perinatal conditions1/1410/140
TachycardiaCardiac disorders1/1410/140
Most frequent other events
Most frequent other events
EventUsual Care GroupLifestyle Intervention Group
Small for gestational ageEndocrine disorders5/1413/140

Baseline characteristics

Age, Continuous
Age, Continuous(years)Usual Care GroupLifestyle Intervention GroupTotal
Mean34 ± 433 ± 433 ± 4
Sex: Female, Male
Sex: Female, Male(Participants)Usual Care GroupLifestyle Intervention GroupTotal
Female141140281
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Usual Care GroupLifestyle Intervention GroupTotal
Hispanic or Latino303060
Not Hispanic or Latino111110221
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Usual Care GroupLifestyle Intervention GroupTotal
American Indian or Alaska Native202
Asian4610
Native Hawaiian or Other Pacific Islander101
Black or African American203454
White9979178
More than one race5914
Unknown or Not Reported101222
Region of Enrollment
Region of Enrollment(participants)Usual Care GroupLifestyle Intervention GroupTotal
United States141140281
Gestational Age at Randomization
Gestational Age at Randomization(weeks)Usual Care GroupLifestyle Intervention GroupTotal
Mean13 ± 113 ± 113 ± 1
Pre-pregnancy BMI
Pre-pregnancy BMI(kg per meters-squared)Usual Care GroupLifestyle Intervention GroupTotal
Mean31 ± 431 ± 431 ± 4
08

Study locations

2 sites
  • Northwestern Memorial Hospital; Prentice Women's
    Chicago, Illinois 60611, United States
  • Northwestern University: Dept of Preventive Medicine
    Chicago, Illinois 60611, United States
09

References and documents

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. PubMed 33238176 ↗
  • 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. PubMed 30262148 ↗
  • 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. PubMed 30230252 ↗
  • 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. PubMed 26708836 ↗

Study documents

  • Protocol and statistical analysis plan · May 28, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01631747
Lead sponsor
Northwestern University
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Linda Van Horn (Professor, Preventive Medicine, Northwestern University) — Principal investigator
First posted
Jun 29, 2012
Start date
Nov 2012
Primary completion
Jul 31, 2017
Completion
Jul 31, 2017
Results posted
Sep 25, 2018
Last update
Nov 6, 2018

Study contacts

Linda V Van Horn, PhD
principal investigator · Northwestern University
Alan Peaceman, MD
principal investigator · Northwestern Memorial Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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