PregnancyMOMFITNCT01631747
Maternal-Offspring Metabolics:Family Intervention Trial
A study testing Lifestyle Intervention Group in people with Pregnancy and Weight Gain, run by Northwestern University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy, Weight Gain
- What is being tested?
- Lifestyle Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2012to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Memorial Hospital; Prentice Women's
Chicago, Illinois, 60611
Northwestern University: Dept of Preventive Medicine
Chicago, Illinois, 60611
About this study
Official title: Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)
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
- Conditions
- Pregnancy, Weight Gain
- Being tested
- Lifestyle Intervention Group, Usual Care Group
- Keywords
- Pregnancy, Weight gain, Obesity, Pregnancy and weight gain
- Medical subject headings
- Weight Gain, Obesity, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Intervention GroupBehavioural
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
Usual Care GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | Active comparator | 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. Receives: Behavioral: Usual Care Group |
| Lifestyle Intervention Group | Experimental | 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 Receives: Behavioral: Lifestyle Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14-37 weeks
Secondary outcomes (16)
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.
Measured: 24-26 weeks
Fasting Glucose
Blood will be collected at Baseline and 35-37 weeks.
Measured: 14-37 wks
High-density Lipoprotein (HDL)
Blood will be collected at Baseline and 35-37 weeks.
Measured: 14-37 wks
Low-density Lipoprotein (LDL)
Blood will be collected at Baseline and 35-37 weeks.
Measured: 14-37 weeks
Total Cholesterol
Blood will be collected at Baseline and 35-37 weeks.
Measured: 14-37 Weeks
Triglycerides
Blood will be collected at Baseline and 35-37 weeks.
Measured: 14-37 Weeks
Leptin
Blood will be collected at Baseline and 35-37 weeks.
Measured: 14-37 weeks
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).
Measured: baseline (14 weeks) and 35-37 weeks
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.
Measured: baseline(14 weeks) and 35-37 weeks
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.
Measured: Baseline (14 weeks) and 35 weeks
Birth Weight
Neonatal Body measurements
Measured: Delivery
Birth Length
Neonate birth measures
Measured: Delivery
Head Circumference
Neonate birth measures
Measured: Delivery
Neonate Percent Body Fat
Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system.
Measured: Delivery
Infant Weight
Infant Body measurements
Measured: 1 year
Infant Length
Infant body measurement
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startNov 2012
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Linda Van Horn, Northwestern University
- Investigators
- Linda V Van Horn, PhD, Principal investigator, Northwestern UniversityAlan Peaceman, MD, Principal investigator, Northwestern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631747
- Sponsor's protocol ID
- DK10-014
- Other IDs
- 1U01HL114344-01
- Acronym
- MOMFIT
- Status last verified
- Oct 2018
- First submitted
- 25 Jun 2012
- Last updated
- 6 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 41029405Flanagan 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.
PubMed 40839263Redman 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 33238176Van 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 30262148Peaceman 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 30230252Clifton 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 at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal-Offspring Metabolics:Family Intervention Trial (MOMFIT)
- ClinicalTrials.gov ID
- NCT01631747
- Acronym / sponsor ID
- MOMFIT / DK10-014
- Conditions
- Pregnancy, Weight Gain
- Keywords
- Pregnancy, Weight gain, Obesity, Pregnancy and weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 2012
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Posted 25 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | Active comparator | Behavioral: Usual Care GroupMom 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 | Experimental | Behavioral: Lifestyle Intervention GroupWomen 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Intervention GroupMoms 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 | Behavioural | Lifestyle Intervention Group |
| Usual Care GroupMom 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. | Behavioural | Usual Care Group |
Primary outcome
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.
16 secondary outcomes
Percentage of Participants With Gestational Diabetes
Time frame: 24-26 weeks
Fasting Glucose
Time frame: 14-37 wks
High-density Lipoprotein (HDL)
Time frame: 14-37 wks
Low-density Lipoprotein (LDL)
Time frame: 14-37 weeks
Total Cholesterol
Time frame: 14-37 Weeks
Triglycerides
Time frame: 14-37 Weeks
Leptin
Time frame: 14-37 weeks
Steady State Beta Cell Function
Time frame: baseline (14 weeks) and 35-37 weeks
Insulin Sensitivity
Time frame: baseline(14 weeks) and 35-37 weeks
Insulin Resistance (IR)
Time frame: Baseline (14 weeks) and 35 weeks
Birth Weight
Time frame: Delivery
Birth Length
Time frame: Delivery
Head Circumference
Time frame: Delivery
Neonate Percent Body Fat
Time frame: Delivery
Infant Weight
Time frame: 1 year
Infant Length
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41029405Cabre 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.
- Derived from this study: PubMed 40839263Flanagan 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.
- Derived from this study: PubMed 33238176Redman 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.
- Derived from this study: PubMed 30262148Van 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.
- Derived from this study: PubMed 30230252Peaceman 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.
- Derived from this study: PubMed 26708836Clifton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda V Van Horn, PhD principal investigator
Northwestern University
Alan Peaceman, MD principal investigator
Northwestern Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention Group in people with Pregnancy and Weight Gain, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational Weight Gain (GWG) (time frame: 14-37 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01631747, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018; AzTrials last refreshed its copy on 6 Nov 2026.