OverweightLIFTNCT01616147
LIFT: Lifestyle Interventions For Two
A study testing Intensive Lifestyle Intervention (ILI) in people with Overweight and Pregnancy, run by Columbia University at 1 site in United States.
Trial summary
This randomized, controlled trial is proposed to study the effect, in a cohort of racially and ethnically diverse group of overweight and obese pregnant women, of an Intensive Lifestyle Intervention (ILI) which utilize cognitive behavioral strategies to help participants achieve and maintain changes in dietary intake… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overweight, Pregnancy
- What is being tested?
- Intensive Lifestyle Intervention (ILI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 31 Aug 2017
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton viable pregnancy
- Gestational age between 9,0 and 15,6
- Body Mass Index of 25 and above
- Age 18 and over
- Ability to contact
Who cannot join
- Less than 18 years old
- Diagnosis of Diabetes or Hemoglobin A1c (HbA1c)> or = 6.5%
- Known fetal anomaly
- Planned termination of pregnancy
- History of 3 more more consecutive first trimester miscarriages
- Current eating disorder
Show all 24Show fewer
- Actively suicidal
- Prior or planned bariatric surgery
- Current use of metformin, systemic steroids, antipsychotic agents, anti-seizure medications, mood stabilizers, attention deficit hyperactivity disorder medications
- Continued use of weight loss medication
- Contraindications to aerobic exercise in pregnancy
- 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 Lifestyle Interventions For Expectant (LIFE) Moms consortium hospital
- Participant's unwillingness or inability to commit to a 1 year follow-up of herself or her child, including planning to move away
- Smoking
- History of Drug and/or Alcohol Addiction
- Chronic health problems that prohibit regular exercise or known to influence body composition
- Other chronic disease as determined by investigators
- Claustrophobia (only for participants who elect to have MRI)
- Implanted metal objects that render MRI unsafe (only for participants who elect to have MRI)
- Lack of support from primary health care provider or family members
- Another member of the household is a study participant or staff member
- Any other medical, psychiatric, social or behavioral factor that in the judgement of the Principal Investigator (PI) may interfere with study participation or ability to follow the intervention protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: LIFT: Lifestyle Interventions For Two (Member of the LIFE Moms Consortium)
This randomized, controlled trial is proposed to study the effect, in a cohort of racially and ethnically diverse group of overweight and obese pregnant women, of an Intensive Lifestyle Intervention (ILI) which utilize cognitive behavioral strategies to help participants achieve and maintain changes in dietary intake and physical activity habits compared to Usual Care (UC) on gestational weight gain (GWG), infant fatness, and mothers' post-delivery weight retention. The hypothesis is that the percent body fat at birth will be significantly less in offspring from ILI mothers than UC mothers.
Read the detailed description
Overall body weight and weight gain during pregnancy have gone up among all women in the United States. Higher body weight of the mother at the time of the baby's conception and a greater weight gain during pregnancy are both associated with more fat in the infant and later overweight in children. Obesity in children has become a great public health problem. This study will use the new Institute of Medicine Guidelines for weight gain during pregnancy. These Guidelines are based on observations showing that women whose weight gain was within the recommended Guidelines had healthier pregnancies and better pregnancy outcomes than those who did not follow the Guidelines. It is important for researchers to understand whether a lifestyle intervention like LIFT can help women have healthier pregnancies and healthier babies. If the researchers find that a lifestyle intervention positively impacts the mothers and their babies, then the researchers can help other pregnant women have healthier pregnancies and babies as well.
This Study, The Lifestyle Intervention For Two (LIFT) Study, is part of the LIFE Moms consortium, a national project involving seven sites across the US. The purpose of the LIFE Moms consortium is to study different ways in which women who are overweight or obese can manage their body weight during pregnancy, and how this may affect them and their baby's health at birth and through the first year. As part of the LIFE Moms consortium, The LIFT Study will look how controlled weight gain during pregnancy will impact the health of the mother and her child. Researchers at Columbia University are investigating the effect of an intensive lifestyle intervention (i.e. diet and physical activity counseling). The researchers hope to positively impact not only body weight gain during pregnancy, but also positively impact infant body fatness and mother's weight loss after pregnancy. The LIFE Moms researchers are looking at whether too much weight gain in the mother will result in a leaner baby, and less retention of fat by the mother following pregnancy.
This study is a randomized controlled trial to study the effect, in a cohort of racially and ethnically diverse group of overweight and obese pregnant women, of an Intensive Lifestyle Intervention (ILI) compared to Usual Care (UC) on gestational weight gain (GWG), infant fatness, and mothers' post-delivery weight retention. Women in the ILI arm will receive intensive counseling during pregnancy and group counseling after delivery regarding behavior, nutrition, and physical activity change. Visits to counselors will occur semi-monthly and additional telephone and internet contacts will occur. The mothers' will be assessed at 14 and 36 weeks of pregnancy and at 14 weeks (range 13-15) and 52 (range 48-56) weeks post-delivery. The measurements will be anthropometry, whole body MRI, EchoMRI, and whole body plethysmography (BodPod). The infants' measurements will be anthropometry, whole body MRI, EchoMRI, and whole body plethysmography (PeaPod) for fatness 14 weeks (range 14-15) weeks and 52 (range 48-56) weeks. Mothers and children will have cardio-metabolic risk factors measured in plasma. Data will be collected regarding mothers' dietary intake and physical activity (questionnaires and accelerometry) to assist in counseling. Other data to be collected include questionnaires on quality of life, socio-economic status. Each mother will be followed during pregnancy and for a year post delivery. Each infant will be followed for a year after birth. The researchers have the ability to continue to follow these participants if further funding is forthcoming, as they are all local to the hospital's catchment area and to own physicians.
- Conditions
- Overweight, Pregnancy
- Being tested
- Intensive Lifestyle Intervention (ILI), Usual Care
- Keywords
- Intensive Lifestyle Intervention
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Lifestyle Intervention (ILI)Behavioural
Women in the ILI arm will receive intensive counseling during pregnancy and group counseling after delivery regarding behavior, nutrition, and physical activity change. Visits to counselors will occur twice monthly with additional weekly telephone and internet contacts.
Usual CareBehavioural
Women in the usual care group will be offered group support classes approximately every 2 months during pregnancy and 3 months after pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Lifestyle Intervention (ILI) | Experimental | Women in the ILI arm will receive intensive counseling during pregnancy and group counseling after delivery regarding behavior, nutrition, and physical activity change. Visits to counselors will occur twice monthly with additional weekly telephone and internet contacts. Receives: Behavioral: Intensive Lifestyle Intervention (ILI) |
| Usual Care | Active comparator | Women in the usual care group will be offered group support classes approximately every 2 months during pregnancy and 3 months after pregnancy. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Percent Fat at Birth
Infant % fat at birth as a continuous variable. This will be ascertained from PeaPod within 24 hours after birth.
Measured: Within 24 hours of birth
Secondary outcomes (7)
Mother fat mass gain 35 Weeks
Fat mass gain of mother at 35,0-35,6 weeks of pregnancy as a continuous variable.
Measured: 35,0-35,6 weeks of pregnancy
Mother fat mass gain one year postpartum
Mother's fat mass at 52 (range 48-56) weeks postpartum
Measured: 48-56 weeks postpartum
Mother's weight one-year postpartum
Weight of mother at 52 (range 48-56) weeks
Measured: 48-56 weeks postpartum
Infant % fat 14 weeks
Infant %fat at 14 (range 13-15) weeks. This will be ascertained from PeaPod.
Measured: 13-15 weeks
Infant % fat 52 weeks
Infant %fat 52 (range 48-56) weeks.
Measured: 48-52 weeks
Infant Weight 14 weeks
Infant weight at 14 (range 13-15) weeks.
Measured: 13-15 weeks
Infant weight 52 weeks
Infant weight at 52 (range 48-56) weeks.
Measured: 48-56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startOct 2012
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Columbia 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
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dympna Gallagher, Columbia University
- Investigators
- Dympna Gallagher, EdD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616147
- Sponsor's protocol ID
- AAAO0651
- Other IDs
- 1U01DK094463
- Acronym
- LIFT
- Status last verified
- Jan 2019
- First submitted
- 7 Jun 2012
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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 40839263Whyte K, Contento I, Wolf R, Guerra L, Martinez E, Pi-Sunyer X, Gallagher D. A secondary analysis of maternal ultra-processed food intake in women with overweight or obesity and associations with gestational weight gain and neonatal body composition outcomes. J Mother Child. 2022 Mar 23;25(4):244-259. doi: 10.34763/jmotherandchild.20212504.d-21-00025. eCollection 2021 Dec 1.
PubMed 35325513Redman 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 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIFT: Lifestyle Interventions For Two (Member of the LIFE Moms Consortium)
- ClinicalTrials.gov ID
- NCT01616147
- Acronym / sponsor ID
- LIFT / AAAO0651
- Conditions
- Overweight, Pregnancy
- Keywords
- Intensive Lifestyle Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2012
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 11 Jun 2012 (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.
This randomized, controlled trial is proposed to study the effect, in a cohort of racially and ethnically diverse group of overweight and obese pregnant women, of an Intensive Lifestyle Intervention (ILI) which utilize cognitive behavioral strategies to help participants achieve and maintain changes in dietary intake and physical activity habits compared to Usual Care (UC) on gestational weight gain (GWG), infant fatness, and mothers' post-delivery weight retention. The hypothesis is that the percent body fat at birth will be significantly less in offspring from ILI mothers than UC mothers.
Detailed description
Overall body weight and weight gain during pregnancy have gone up among all women in the United States. Higher body weight of the mother at the time of the baby's conception and a greater weight gain during pregnancy are both associated with more fat in the infant and later overweight in children. Obesity in children has become a great public health problem. This study will use the new Institute of Medicine Guidelines for weight gain during pregnancy. These Guidelines are based on observations showing that women whose weight gain was within the recommended Guidelines had healthier pregnancies and better pregnancy outcomes than those who did not follow the Guidelines. It is important for researchers to understand whether a lifestyle intervention like LIFT can help women have healthier pregnancies and healthier babies. If the researchers find that a lifestyle intervention positively impacts the mothers and their babies, then the researchers can help other pregnant women have healthier pregnancies and babies as well.
This Study, The Lifestyle Intervention For Two (LIFT) Study, is part of the LIFE Moms consortium, a national project involving seven sites across the US. The purpose of the LIFE Moms consortium is to study different ways in which women who are overweight or obese can manage their body weight during pregnancy, and how this may affect them and their baby's health at birth and through the first year. As part of the LIFE Moms consortium, The LIFT Study will look how controlled weight gain during pregnancy will impact the health of the mother and her child. Researchers at Columbia University are investigating the effect of an intensive lifestyle intervention (i.e. diet and physical activity counseling). The researchers hope to positively impact not only body weight gain during pregnancy, but also positively impact infant body fatness and mother's weight loss after pregnancy. The LIFE Moms researchers are looking at whether too much weight gain in the mother will result in a leaner baby, and less retention of fat by the mother following pregnancy.
This study is a randomized controlled trial to study the effect, in a cohort of racially and ethnically diverse group of overweight and obese pregnant women, of an Intensive Lifestyle Intervention (ILI) compared to Usual Care (UC) on gestational weight gain (GWG), infant fatness, and mothers' post-delivery weight retention. Women in the ILI arm will receive intensive counseling during pregnancy and group counseling after delivery regarding behavior, nutrition, and physical activity change. Visits to counselors will occur semi-monthly and additional telephone and internet contacts will occur. The mothers' will be assessed at 14 and 36 weeks of pregnancy and at 14 weeks (range 13-15) and 52 (range 48-56) weeks post-delivery. The measurements will be anthropometry, whole body MRI, EchoMRI, and whole body plethysmography (BodPod). The infants' measurements will be anthropometry, whole body MRI, EchoMRI, and whole body plethysmography (PeaPod) for fatness 14 weeks (range 14-15) weeks and 52 (range 48-56) weeks. Mothers and children will have cardio-metabolic risk factors measured in plasma. Data will be collected regarding mothers' dietary intake and physical activity (questionnaires and accelerometry) to assist in counseling. Other data to be collected include questionnaires on quality of life, socio-economic status. Each mother will be followed during pregnancy and for a year post delivery. Each infant will be followed for a year after birth. The researchers have the ability to continue to follow these participants if further funding is forthcoming, as they are all local to the hospital's catchment area and to own physicians.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Lifestyle Intervention (ILI) | Experimental | Behavioral: Intensive Lifestyle Intervention (ILI)Women in the ILI arm will receive intensive counseling during pregnancy and group counseling after delivery regarding behavior, nutrition, and physical activity change. Visits to counselors will occur twice monthly with additional weekly telephone and internet contacts. |
| Usual Care | Active comparator | Behavioral: Usual CareWomen in the usual care group will be offered group support classes approximately every 2 months during pregnancy and 3 months after pregnancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Singleton viable pregnancy
- Gestational age between 9,0 and 15,6
- Body Mass Index of 25 and above
- Age 18 and over
- Ability to contact
Key exclusion criteria (24 listed)
- Less than 18 years old
- Diagnosis of Diabetes or Hemoglobin A1c (HbA1c)> or = 6.5%
- Known fetal anomaly
- Planned termination of pregnancy
- History of 3 more more consecutive first trimester miscarriages
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 |
|---|---|---|
| Intensive Lifestyle Intervention (ILI)Women in the ILI arm will receive intensive counseling during pregnancy and group counseling after delivery regarding behavior, nutrition, and physical activity change. Visits to counselors will occur twice monthly with additional weekly telephone and internet contacts. | Behavioural | Intensive Lifestyle Intervention (ILI) |
| Usual CareWomen in the usual care group will be offered group support classes approximately every 2 months during pregnancy and 3 months after pregnancy. | Behavioural | Usual Care |
Primary outcome
Infant Percent Fat at Birth
Time frame: Within 24 hours of birth
Infant % fat at birth as a continuous variable. This will be ascertained from PeaPod within 24 hours after birth.
7 secondary outcomes
Mother fat mass gain 35 Weeks
Time frame: 35,0-35,6 weeks of pregnancy
Mother fat mass gain one year postpartum
Time frame: 48-56 weeks postpartum
Mother's weight one-year postpartum
Time frame: 48-56 weeks postpartum
Infant % fat 14 weeks
Time frame: 13-15 weeks
Infant % fat 52 weeks
Time frame: 48-52 weeks
Infant Weight 14 weeks
Time frame: 13-15 weeks
Infant weight 52 weeks
Time frame: 48-56 weeks
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 1 Feb 2019.
- 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 35325513Whyte K, Contento I, Wolf R, Guerra L, Martinez E, Pi-Sunyer X, Gallagher D. A secondary analysis of maternal ultra-processed food intake in women with overweight or obesity and associations with gestational weight gain and neonatal body composition outcomes. J Mother Child. 2022 Mar 23;25(4):244-259. doi: 10.34763/jmotherandchild.20212504.d-21-00025. eCollection 2021 Dec 1.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
Dympna Gallagher, EdD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Lifestyle Intervention (ILI) in people with Overweight and Pregnancy, run by Columbia University 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 5 inclusion and 24 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 1 Feb 2019. 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.
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?
Infant Percent Fat at Birth (time frame: Within 24 hours of birth). 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 NCT01616147, 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 1 Feb 2019.