LIFT: Lifestyle Interventions For Two
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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) |
- 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.
- 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: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ILI |
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 weekly and additional telephone and internet contacts will occur.
|
| Active Comparator: Usual Care |
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 weekly and additional telephone and internet contacts will occur. The mothers' will be assessed at 14 (9,0-14,6) 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, 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 13-15) 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. 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 to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Nulliparous (no pregnancy lasting 20 weeks or more)
- Singleton viable pregnancy
- Gestational age between 9,0 and 14,6
- Body Mass Index 25-35
- Age 18-40
- 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, ADHD 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
- Implanted metal objects that render MRI unsafe
- 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| Contact: Michelle Horowitz, MS, RD | 2125238715 | mhorowit@chpnet.org |
| Contact: Mary Anne Holowaty, MS, CN | 2125235861 | mholowat@chpnet.org |
| 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 | |
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: | December 12, 2012 |
| 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 June 17, 2013