An interventional study of Intensive Lifestyle Intervention (ILI) and Usual Care in Overweight and Pregnancy, sponsored by Columbia University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-01.
Sponsored by Columbia University · Not applicable, Interventional, and Prevention
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.
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.
3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.
This study's enrollment of 210 is above the median of 73 across 3,263 interventional studies indexed under Overweight.
Browse Overweight studies →Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.
Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.
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Exclusion Criteria:
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 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 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.
Infant Percent Fat at Birth
Infant % fat at birth as a continuous variable. This will be ascertained from PeaPod within 24 hours after birth.
Time frame: Within 24 hours of birth
Mother fat mass gain 35 Weeks
Fat mass gain of mother at 35,0-35,6 weeks of pregnancy as a continuous variable.
Time frame: 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
Time frame: 48-56 weeks postpartum
Mother's weight one-year postpartum
Weight of mother at 52 (range 48-56) weeks
Time frame: 48-56 weeks postpartum
Infant % fat 14 weeks
Infant %fat at 14 (range 13-15) weeks. This will be ascertained from PeaPod.
Time frame: 13-15 weeks
Infant % fat 52 weeks
Infant %fat 52 (range 48-56) weeks.
Time frame: 48-52 weeks
Infant Weight 14 weeks
Infant weight at 14 (range 13-15) weeks.
Time frame: 13-15 weeks
Infant weight 52 weeks
Infant weight at 52 (range 48-56) weeks.
Time frame: 48-56 weeks
Plan to share: Undecided
The record gives a start of Oct 2012, a primary completion of Aug 2017 and a completion of Aug 2017. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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