LIFT: Lifestyle Interventions For Two

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by St. Luke's-Roosevelt Hospital Center
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01616147
First received: June 7, 2012
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

A 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) 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.


Condition Intervention
Overweight
Pregnancy
Behavioral: Intensive Lifestyle Intervention (ILI)
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: LIFT: Lifestyle Interventions For Two (Member of the LIFE Moms Consortium)

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Infant Percent Fat at Birth [ Time Frame: Within 24 hours of birth ] [ Designated as safety issue: No ]
    Infant % fat at birth as a continuous variable. This will be ascertained from PeaPod within 24 hours after birth.


Secondary Outcome Measures:
  • Mother fat mass gain 35 Weeks [ Time Frame: 35,0-35,6 weeks of pregnancy ] [ Designated as safety issue: No ]
    Fat mass gain of mother at 35,0-35,6 weeks of pregnancy as a continuous variable.

  • Mother fat mass gain one year postpartum [ Time Frame: 48-56 weeks postpartum ] [ Designated as safety issue: No ]
    Mother's fat mass at 52 (range 48-56) weeks postpartum

  • Mother's weight one-year postpartum [ Time Frame: 48-56 weeks postpartum ] [ Designated as safety issue: No ]
    Weight of mother at 52 (range 48-56) weeks

  • Infant % fat 14 weeks [ Time Frame: 13-15 weeks ] [ Designated as safety issue: No ]
    Infant %fat at 14 (range 13-15) weeks. This will be ascertained from PeaPod.

  • Infant % fat 52 weeks [ Time Frame: 48-52 weeks ] [ Designated as safety issue: No ]
    Infant %fat 52 (range 48-56) weeks.

  • Infant Weight 14 weeks [ Time Frame: 13-15 weeks ] [ Designated as safety issue: No ]
    Infant weight at 14 (range 13-15) weeks.

  • Infant weight 52 weeks [ Time Frame: 48-56 weeks ] [ Designated as safety issue: No ]
    Infant weight at 52 (range 48-56) weeks.


Estimated Enrollment: 210
Study Start Date: October 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Active Comparator: Usual Care
Women in the usual care group will be offered group support classes approximately every 2 months during pregnancy and 3 months after pregnancy.
Behavioral: Usual Care
Women in the usual care group will be offered group support classes approximately every 2 months during pregnancy and 3 months after pregnancy.

Detailed Description:

A 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) 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 bi-monthly and additional telephone and internet contacts will occur weekly. The mothers' will be assessed at 14 (9,0-15,6) and 36 (35,0-36,6) weeks of pregnancy and at 14 weeks (range 13-15) and 52 (range 48-56) weeks post-delivery. The measurements will be anthropometry and whole body plethysmography (BodPod). Additional optional measures include whole body MRI and EchoMRI. The infants' measurements will be anthropometry and whole body plethysmography (PeaPod) for fatness 14 weeks (range 13-15) weeks and 52 (range 48-56) weeks. Additional optional measures include whole body MRI and EchoMRI. 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. Careful record will be kept of expenses in providing the ILI, so that cost analysis of the intervention can be calculated. The study is powered on the primary outcome, fatness of the infants at birth. We require 180 participants to attain appropriate power. We will enroll 210 so as to allow for some dropouts along the way. Each mother will be followed during pregnancy and for a year post delivery. Each infant will be followed for a year after birth. We have the ability to continue to follow these participants if further funding is forthcoming, as they are all local to our hospital's catchment area and our own physicians.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Less than 18 years old
  • Diagnosis of Diabetes or 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 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 PI may interfere with study participation or ability to follow the intervention protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616147

Contacts
Contact: Michelle Horowitz, MS, RD 2125238713 mhorowit@chpnet.org
Contact: Kim Kelly-Dinham 2125238715 kkelly@chpnet.org

Locations
United States, New York
St. Luke's Roosevelt Hospital, Antenucci Building Recruiting
New York, New York, United States, 10019
Contact: Michelle Horowitz, MS    212-523-8715    mhorowit@chpnet.org   
Principal Investigator: Dympna Gallagher, EdD         
Principal Investigator: Xavier Pi-Sunyer, MD, MPH         
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Dympna Gallagher, EdD St. Luke's-Roosevelt Hospital Center
  More Information

No publications provided

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01616147     History of Changes
Other Study ID Numbers: 1U01DK094463
Study First Received: June 7, 2012
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014