LIFT: Lifestyle Interventions For Two
LIFT
2 other identifiers
interventional
210
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2012
CompletedFirst Posted
Study publicly available on registry
June 11, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2017
CompletedFebruary 1, 2019
January 1, 2019
4.9 years
June 7, 2012
January 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infant Percent Fat at Birth
Infant % fat at birth as a continuous variable. This will be ascertained from PeaPod within 24 hours after birth.
Within 24 hours of birth
Secondary Outcomes (7)
Mother fat mass gain 35 Weeks
35,0-35,6 weeks of pregnancy
Mother fat mass gain one year postpartum
48-56 weeks postpartum
Mother's weight one-year postpartum
48-56 weeks postpartum
Infant % fat 14 weeks
13-15 weeks
Infant % fat 52 weeks
48-52 weeks
- +2 more secondary outcomes
Study Arms (2)
Intensive Lifestyle Intervention (ILI)
EXPERIMENTALWomen 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 COMPARATORWomen in the usual care group will be offered group support classes approximately every 2 months during pregnancy and 3 months after pregnancy.
Interventions
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.
Women in the usual care group will be offered group support classes approximately every 2 months during pregnancy and 3 months after pregnancy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
Related Publications (6)
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.
PMID: 41029405DERIVEDFlanagan 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.
PMID: 40839263DERIVEDWhyte 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.
PMID: 35325513DERIVEDRedman 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.
PMID: 33238176DERIVEDPeaceman 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.
PMID: 30230252DERIVEDClifton 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.
PMID: 26708836DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dympna Gallagher, EdD
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Nutritional Medicine at CUMC
Study Record Dates
First Submitted
June 7, 2012
First Posted
June 11, 2012
Study Start
October 1, 2012
Primary Completion
August 31, 2017
Study Completion
August 31, 2017
Last Updated
February 1, 2019
Record last verified: 2019-01