ObesityPhase 3NCT01812694
Lifestyle Interventions for Expectant Mothers (LIFE-Moms Phoenix) - Phoenix
A Phase 3 study testing Intensive lifestyle intervention in people with Obesity and Diet Therapy, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: LIFE-Moms (Lifestyle Interventions for Expectant Moms) is a national project that is studying pregnant women who are overweight or obese. It is looking at ways they can manage their weight gain in pregnancy and how this may affect them and their babies health at birth and through the first year. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity, Diet Therapy, Diabetes Type 2
- What is being tested?
- Intensive lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2013to 27 Mar 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult pregnant women of any race or ethnicity may participate if they meet each of the following inclusion criteria:
- At least 18 years of age.
- Receive prenatal care at the nurse midwifery/obstetrics service of PIMC and plan to continue receiving such care throughout the pregnancy.
- Able to have an OGTT prior to 16 weeks gestation. Hyperemesis can preclude some pregnant women from successfully completing the OGTT; these women will not be excluded if the fasting blood samples can be obtained.
- Able to have an ultrasound examination to estimate fetal age.
- Complete initial run-in screening visits to determine whether the woman can manage the tasks required of participation in an intensive intervention if randomized to the intervention group.
Show all 10Show fewer
- Able to commit the time required for the interventions and follow-up.
- Singleton viable pregnancy. A twin pregnancy reduced to singleton before 14(0) weeks by project gestational age is acceptable. 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(6) weeks based on an algorithm that compares the LMP date and data from the earliest ultrasound.
- Body mass index greater than or equal to 25 kilogram / square meter based on first trimester measured weight and on measured height. The earliest weight measurement before randomization, measured specifically for the study, will be used. Reported pre-pregnancy weight will not be used to determine eligibility because of the potential for inaccuracy. If the earliest weight measurement is conducted at 14(0) to 14(6) weeks or 15(0) to 15(6) weeks, 1 pound or 2 pounds will be subtracted from the measured weight, respectively, to adjust to a first trimester weight. This weight and the resultant BMI are defined as the baseline weight and BMI, respectively.
Who cannot join
- Diagnosis of diabetes prior to pregnancy or any of the following results of the oral glucose tolerance test at visit #1 that suggest diabetes prior to pregnancy: HbA1c greater than or equal 6.5 %, FPG greater than or equal 126 milligrams per deciliter, or 2-hour post-load plasma glucose greater than or equal 200 milligrams per deciliter (75 grams oral glucose tolerance test). All potential participants will have HbA1c and a 75 grams oral glucose tolerance test performed prior to randomization.
- Women who meet the above criteria for diagnosed or presumed diabetes prior to pregnancy will be excluded. Others who meet criteria for GDM will be eligible. Criteria for GDM diagnosis will be based on ADA 2012 criteria (at least one of FPG greater than or equal to 92 milligrams per deciliter, 1 hour PG greater than or equal 180 milligrams per deciliter, or 2 hour PG greater than or equal to 153 milligrams per deciliter.)
- Known fetal anomaly
- Planned termination of pregnancy
- History of three or more consecutive first trimester miscarriages
- Past history of anorexia or bulimia by medical history or patient report. Binge eating disorder (BED) is not an exclusion.
Show all 33Show fewer
- Current eating disorder diagnosed by EDE-Q questions 2-4 and confirmed after discussion with the participant by study staff
- Actively suicidal defined as a value greater than or equal 2 on the BDI-II question 9
- Prior or planned (within 1 year of expected delivery) bariatric surgery
- Current use of one or more of the following medications:
- Metformin
- Systemic steroids
- Antipsychotic agents (e.g., Abilify (apriprazole), Haldol (haloperidol), Risperdal (resperidone), Seroquel (quetipapine), Zyprexa (olanzapine))
- Anti-seizure medications or mood stabilizers that would be expected to have a significant impact on body weight (e.g., Depakote (valproic acid), Lamictal (lamotrigine), Lithium, Neurontin (gabapentin), Tegretol (carbamazepine), Topamax (topiramate), Keppra (levetiracetam)
- Medications for ADHD including amphetamines and methylphenidate
- Any teratogenic agent Class D or X (site specific)
- Continued use of weight loss medication including OTC and dietary supplements for weight loss (e.g., Adipex (phentermine), Suprenza(phentermine) Tenuate (dietheylpropion), Xenical (orlistat), Alli (orlistat), conjugated linoleic acid, Hoodia, Green tea extract, Guar gum, HydroxyCut, Sensa, Corti-slim, Chromium, chitosan, Bitter orange)
- Contraindications to aerobic exercise in pregnancy specified in the ACOG Committee Opinion #267, 2002
- Hemodynamically significant heart disease defined as an AHA class II (short of breath with exercise) or greater
- Restrictive lung disease (e.g. pulmonary fibrosis)
- Poorly controlled hyperthyroidism
- Poorly controlled seizure disorder
- Poorly controlled hypertension defined as a blood pressure greater than or equal 160/110 millimeters of mercury
- History of extreme sedentary lifestyle (e.g. bed bound)
- Orthopedic limitations to aerobic exercise
- Severe anemia defined as a hemoglobin less than 8 grams per deciliter
- Any condition that requires follow-up at specialty care clinics outside of PIMC (e.g., pregnancies at high risk for maternal or fetal demise)
- Participation in another interventional study that influences weight control
- Enrollment in this trial in a previous pregnancy
- Intention of the participant or of the care provider for the delivery to be outside the greater Phoenix metropolitan area.
- Participant s unwillingness or inability to commit to a 1 year follow-up of herself or her child, including planning to move away.
- Inability or unwillingness to provide informed consent, in the English language, including consent for study staff to abstract data from all prenatal and delivery records (for the current pregnancy) whether the care or delivery occur at PIMC or elsewhere. English is the common language of the participants who receive care at PIMC. Some also speak tribal languages or Spanish. English is the language used in the intervention materials, the screening forms, and online documents. English is also the primary language of study staff.
- Any condition that in the opinion of the investigators would interfere with consent, treatment or follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lifestyle Interventions for Expectant Moms (LIFE-Moms) Phoenix
Background:
- LIFE-Moms (Lifestyle Interventions for Expectant Moms) is a national project that is studying pregnant women who are overweight or obese. It is looking at ways they can manage their weight gain in pregnancy and how this may affect them and their babies health at birth and through the first year. Researchers want to recruit pregnant women who are being treated at the Phoenix Indian Medical Center. They will participate in a two-part study.
Read more
Objectives:
- To study pregnant women who are in the LIFE-Moms project at the Phoenix Indian Medical Center.
Eligibility:
- Pregnant women at least 18 years of age who are overweight or obese.
- Participants must be receiving care at the Phoenix Indian Medical Center.
- Participants must be having only one child in their pregnancy (no twins or other multiple births).
Design:
- This study will have two parts. The first part will have three visits to obtain data about health early in pregnancy. It will also let participants and researchers find out if the participants are eligible and should continue in the second part of the study. In the second part, participants will be monitored throughout their pregnancy and during the first year after the baby s birth to test the effects of a lifestyle intervention to control weight gain during pregnancy.
- On the Part 1 study visits, participants will have a physical exam and medical history. They will provide blood, urine, hair, and other samples to be examined for possible genetic conditions.
- For the Part 2 study visits, participants will be placed in one of two treatment groups. Each group will receive the same prenatal and postnatal care that they would get if they did not join the study.
- The first group will have a lifestyle intervention program. They will spend about 2 hours every week with other members of their group to learn diet and activity behaviors that may help with their health.
- The second group will have an enhanced care program. They will be given additional information about health and pregnancy and be invited to attend three classes to learn about staying healthy during pregnancy.
Read the detailed description
LIFE-Moms (Phoenix center) is a randomized clinical trial in overweight and obese pregnant women that will test the effects of an intensive lifestyle intervention on gestational weight gain, control of maternal hyperglycemia, and post-partum return to pre-pregnancy weight. The Phoenix center will be conducted in collaboration between the Phoenix Indian Medical Center (PIMC) nurse midwifery and obstetrics services and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). It is part of the LIFE-Moms Consortium consisting of six other clinical centers that will follow similar protocols and a research coordination unit.
American Indians are at high risk for developing obesity and type 2 diabetes mellitus (T2DM) and its complications. A major factor responsible for this finding is exposure of the fetus in the womb to its mother s diabetes, which increases the risk of diabetes in the offspring particularly during childhood and adolescence. This study is designed to evaluate the effects of an intensive lifestyle intervention (ILI) in at least 200 adult (age greater than or equal to 18 years) pregnant women who are eligible for prenatal care at PIMC. Interventions will be provided to overweight and obese pregnant women who do not have pregestational diabetes but may have (GDM), i.e., diabetes that first develops or is first recognized in pregnancy, or are at high risk of developing GDM. The lifestyle intervention will be patterned after the Diabetes Prevention Program (DPP) that prevented or delayed the onset of diabetes in non pregnant adults; the interventions will be modified to be appropriate in pregnancy. For women who develop diabetes, interventions will include coaching to optimize glycemic control.
Women will be randomly assigned to one of two intervention groups, assigned with equal probability: an enhanced standard of care group or an intensive lifestyle intervention group (ILI). Following delivery, all the mothers and infants will be treated in the same way regardless of their initial treatment group. For example, all mothers will be encouraged to breast feed and follow other recommended practices for the health of themselves and their babies. After delivery the mother will be invited to bring the infant to the research clinic five times during the first 6 months and again at 1 year of age. These follow up visits for the infant are timed 1) to understand the patterns of change in neonatal body composition and 2) to coincide, when possible, with well-child pediatric visits. We will also question the mothers and abstract data from the medical record regarding the child s feeding practice, overall health, hospitalizations, immunizations, and medicine use.
Outcomes will be assessed on the same schedule for both intervention groups. Prenatal measurements include demographic, anthropometric, and biochemical data. The latter will focus on periodic measures related to blood glucose (sugar), including glucose tolerance tests. Diet and physical activity will be assessed by questionnaires and objective activity monitors. Many of these tests will be repeated in the mother at 6-12 weeks and 12 months post-partum. Infant data at or shortly after birth and at months 1 through 6 and 12 will include weight, length, head size, estimated body fat, feeding practices, and medical record abstraction.
- Conditions
- Obesity, Diet Therapy, Diabetes Type 2
- Being tested
- Enhanced standard care, Intensive lifestyle intervention
- Keywords
- Pregnancy, Weight Control, Weight Gain
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced standard careBehavioural
Standard prenatal care plus education
Intensive lifestyle interventionBehavioural
Intervention to limit excess gestational weight gain
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Standard Care | Active comparator | Standard prenatal care plus education Receives: Behavioral: Enhanced standard care |
| Intensive lifestyle intervention | Experimental | Intervention to limit excess gestational weight gain Receives: Behavioral: Intensive lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational weight gain
Weight at 36 weeks minus weight at baseline, kg
Measured: 36 weeks
Secondary outcomes (1)
Gestational Diabetes
Neonatal weight for height will be plotted from birth and at study visits up to 12 months of age
Measured: 24-28 weeks gestation, 6 weeks post-partum and 1 year post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study start28 Mar 2013
- Primary completion27 Mar 2017
- Study completion27 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mary A Hoskin, R.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812694
- Sponsor's protocol ID
- 999913055
- Other IDs
- 13-DK-N055
- Status last verified
- 12 Feb 2026
- First submitted
- 14 Mar 2013
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 33238176Peaceman 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Interventions for Expectant Moms (LIFE-Moms) Phoenix
- ClinicalTrials.gov ID
- NCT01812694
- Acronym / sponsor ID
- 999913055
- Conditions
- Obesity, Diet Therapy, Diabetes Type 2
- Keywords
- Pregnancy, Weight Control, Weight Gain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 28 Mar 2013 (actual)
- Primary completion
- 27 Mar 2017 (actual)
- Study completion
- 27 Mar 2017 (actual)
- First posted
- 18 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- LIFE-Moms (Lifestyle Interventions for Expectant Moms) is a national project that is studying pregnant women who are overweight or obese. It is looking at ways they can manage their weight gain in pregnancy and how this may affect them and their babies health at birth and through the first year. Researchers want to recruit pregnant women who are being treated at the Phoenix Indian Medical Center. They will participate in a two-part study.
Objectives:
- To study pregnant women who are in the LIFE-Moms project at the Phoenix Indian Medical Center.
Eligibility:
- Pregnant women at least 18 years of age who are overweight or obese.
- Participants must be receiving care at the Phoenix Indian Medical Center.
- Participants must be having only one child in their pregnancy (no twins or other multiple births).
Design:
- This study will have two parts. The first part will have three visits to obtain data about health early in pregnancy. It will also let participants and researchers find out if the participants are eligible and should continue in the second part of the study. In the second part, participants will be monitored throughout their pregnancy and during the first year after the baby s birth to test the effects of a lifestyle intervention to control weight gain during pregnancy.
- On the Part 1 study visits, participants will have a physical exam and medical history. They will provide blood, urine, hair, and other samples to be examined for possible genetic conditions.
- For the Part 2 study visits, participants will be placed in one of two treatment groups. Each group will receive the same prenatal and postnatal care that they would get if they did not join the study.
- The first group will have a lifestyle intervention program. They will spend about 2 hours every week with other members of their group to learn diet and activity behaviors that may help with their health.
- The second group will have an enhanced care program. They will be given additional information about health and pregnancy and be invited to attend three classes to learn about staying healthy during pregnancy.
Detailed description
LIFE-Moms (Phoenix center) is a randomized clinical trial in overweight and obese pregnant women that will test the effects of an intensive lifestyle intervention on gestational weight gain, control of maternal hyperglycemia, and post-partum return to pre-pregnancy weight. The Phoenix center will be conducted in collaboration between the Phoenix Indian Medical Center (PIMC) nurse midwifery and obstetrics services and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). It is part of the LIFE-Moms Consortium consisting of six other clinical centers that will follow similar protocols and a research coordination unit.
American Indians are at high risk for developing obesity and type 2 diabetes mellitus (T2DM) and its complications. A major factor responsible for this finding is exposure of the fetus in the womb to its mother s diabetes, which increases the risk of diabetes in the offspring particularly during childhood and adolescence. This study is designed to evaluate the effects of an intensive lifestyle intervention (ILI) in at least 200 adult (age greater than or equal to 18 years) pregnant women who are eligible for prenatal care at PIMC. Interventions will be provided to overweight and obese pregnant women who do not have pregestational diabetes but may have (GDM), i.e., diabetes that first develops or is first recognized in pregnancy, or are at high risk of developing GDM. The lifestyle intervention will be patterned after the Diabetes Prevention Program (DPP) that prevented or delayed the onset of diabetes in non pregnant adults; the interventions will be modified to be appropriate in pregnancy. For women who develop diabetes, interventions will include coaching to optimize glycemic control.
Women will be randomly assigned to one of two intervention groups, assigned with equal probability: an enhanced standard of care group or an intensive lifestyle intervention group (ILI). Following delivery, all the mothers and infants will be treated in the same way regardless of their initial treatment group. For example, all mothers will be encouraged to breast feed and follow other recommended practices for the health of themselves and their babies. After delivery the mother will be invited to bring the infant to the research clinic five times during the first 6 months and again at 1 year of age. These follow up visits for the infant are timed 1) to understand the patterns of change in neonatal body composition and 2) to coincide, when possible, with well-child pediatric visits. We will also question the mothers and abstract data from the medical record regarding the child s feeding practice, overall health, hospitalizations, immunizations, and medicine use.
Outcomes will be assessed on the same schedule for both intervention groups. Prenatal measurements include demographic, anthropometric, and biochemical data. The latter will focus on periodic measures related to blood glucose (sugar), including glucose tolerance tests. Diet and physical activity will be assessed by questionnaires and objective activity monitors. Many of these tests will be repeated in the mother at 6-12 weeks and 12 months post-partum. Infant data at or shortly after birth and at months 1 through 6 and 12 will include weight, length, head size, estimated body fat, feeding practices, and medical record abstraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Standard Care | Active comparator | Behavioral: Enhanced standard careStandard prenatal care plus education |
| Intensive lifestyle intervention | Experimental | Behavioral: Intensive lifestyle interventionIntervention to limit excess gestational weight gain |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Adult pregnant women of any race or ethnicity may participate if they meet each of the following inclusion criteria:
- At least 18 years of age.
- Receive prenatal care at the nurse midwifery/obstetrics service of PIMC and plan to continue receiving such care throughout the pregnancy.
- Able to have an OGTT prior to 16 weeks gestation. Hyperemesis can preclude some pregnant women from successfully completing the OGTT; these women will not be excluded if the fasting blood samples can be obtained.
- Able to have an ultrasound examination to estimate fetal age.
Key exclusion criteria (33 listed)
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 |
|---|---|---|
| Enhanced standard careStandard prenatal care plus education | Behavioural | Enhanced Standard Care |
| Intensive lifestyle interventionIntervention to limit excess gestational weight gain | Behavioural | Intensive lifestyle intervention |
Primary outcome
Gestational weight gain
Time frame: 36 weeks
Weight at 36 weeks minus weight at baseline, kg
1 secondary outcome
Gestational Diabetes
Time frame: 24-28 weeks gestation, 6 weeks post-partum and 1 year post partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- 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 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.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Mary A Hoskin, R.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intensive lifestyle intervention in people with Obesity and Diet Therapy, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site 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 10 inclusion and 33 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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 36 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 NCT01812694, which also lists 5 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 8 Oct 2026.