LIFT: Lifestyle Interventions For Two

Completed · Not applicable

Conditions studied: Overweight, Pregnancy

In brief

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.

Key facts

Study ID

NCT01616147

Run by

Columbia University

People needed

210

Starts

2012-10-01

Expected to finish

2017-08-31

Last updated by the study team

2019-02-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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