Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-27 @ 10:48 PM
Study NCT ID:
NCT01693666
Status:
COMPLETED
Last Update Posted:
2015-10-02
First Post:
2012-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle Intervention Forever: Healthy Weight for Pregnancy and Birth (Pilot Study)
Sponsor:
St. Louis University
Organization:
Study Overview
Official Title:
Lifestyle Intervention Forever: Healthy Weight for Pregnancy and Birth (Pilot Study)
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gaining too much weight in pregnancy is associated with adverse pregnancy complications and can have a long-term impact on maternal and offspring health, including increased risk for obesity and metabolic disease. Preventing excessive gestational weight gain could reduce adverse pregnancy outcomes and improve long-term health of mothers and offspring. Thirty obese (BMI ≥30) pregnant women will be recruited for this pilot study and randomly assigned to the Lifestyle Intervention ForEver (LIFE) program or routine care (RC). Participants will be enrolled before 18 weeks gestation and will be followed until 12 weeks after delivery. Women in the LIFE program will be given guidance on healthy eating and exercise at their regularly scheduled obstetric visits. To increase adherence to the program, a contingency management (CM) intervention offering incentives will be used to establish and maintain healthy nutrition and physical activity habits, working towards the goal of restricted weight gain (± 10lb) during their pregnancy. Three study testing visits will be scheduled for all participants: at study entry, 34-36 weeks gestation, and 12 weeks after delivering. Primary outcomes include adherence to the LIFE program, weight change in pregnancy and postpartum, and objective measures of maternal and offspring health.
Detailed Description:
The ultimate goal of this research is to examine the impact of a healthy lifestyle intervention, targeting weight gain restriction during pregnancy in obese women (BMI≥30kg/m2), on maternal and fetal outcomes.
The overarching research program has 3 main objectives:
1. To establish an effective contingency management behavioral program (LIFE), increasing adherence to nutritional recommendations and exercise guidelines during pregnancy.
2. To examine the impact of the LIFE program on weight gain restriction during pregnancy and postpartum weight loss in obese women in comparison to the RC group.
3. To examine the impact of the LIFE program on short- and long-term maternal and offspring outcomes at study enrollment, 34-36 weeks gestation and 3 months postpartum in obese women in comparison to the RC group.
* Maternal Outcomes: body composition; peak aerobic capacity; maternal hormonal/metabolic profiles (fasted blood sample); obstetric parameters (incidence of GDM, preeclampsia, cesarean deliveries, obstetric trauma and neonatal complications)
* Offspring Outcomes: fetal growth pattern (fetal ultrasound); neonatal anthropometry assessed ≤ 48 h of birth (crown-heel length, weight, head, chest and waist circumferences, skinfold analyses); metabolic markers at birth (cord blood); and infant anthropometry at 12 weeks of age (as above).
The experimental hypotheses to be tested are that participation in the LIFE intervention in obese pregnant women will prevent excessive weight gain and/or achieve weight maintenance (± 10 lb) during pregnancy and will result in 7-10% weight loss at 12 weeks postpartum. Secondly, we hypothesize that participation in the LIFE intervention in obese pregnant women will be associated with improved aerobic capacity, reduced incidence of obstetric complications and reduced rates of LGA as a result of beneficial alterations to metabolic intrauterine environment for fetal growth.
With regard to this IRB application, we will be conducting a pilot and feasibility trial to address the following specific aims:
1. To establish the feasibility of the LIFE program as a large-scale funded project, including participant engagement in the intervention and all study visits.
2. To evaluate the feasibility of the LIFE program in achieving weight maintenance and postpartum weight loss targets in obese pregnant women across all three obesity classes.
3. To develop and refine the study materials for the LIFE program and assessment battery.
The overarching research program has 3 main objectives:
1. To establish an effective contingency management behavioral program (LIFE), increasing adherence to nutritional recommendations and exercise guidelines during pregnancy.
2. To examine the impact of the LIFE program on weight gain restriction during pregnancy and postpartum weight loss in obese women in comparison to the RC group.
3. To examine the impact of the LIFE program on short- and long-term maternal and offspring outcomes at study enrollment, 34-36 weeks gestation and 3 months postpartum in obese women in comparison to the RC group.
* Maternal Outcomes: body composition; peak aerobic capacity; maternal hormonal/metabolic profiles (fasted blood sample); obstetric parameters (incidence of GDM, preeclampsia, cesarean deliveries, obstetric trauma and neonatal complications)
* Offspring Outcomes: fetal growth pattern (fetal ultrasound); neonatal anthropometry assessed ≤ 48 h of birth (crown-heel length, weight, head, chest and waist circumferences, skinfold analyses); metabolic markers at birth (cord blood); and infant anthropometry at 12 weeks of age (as above).
The experimental hypotheses to be tested are that participation in the LIFE intervention in obese pregnant women will prevent excessive weight gain and/or achieve weight maintenance (± 10 lb) during pregnancy and will result in 7-10% weight loss at 12 weeks postpartum. Secondly, we hypothesize that participation in the LIFE intervention in obese pregnant women will be associated with improved aerobic capacity, reduced incidence of obstetric complications and reduced rates of LGA as a result of beneficial alterations to metabolic intrauterine environment for fetal growth.
With regard to this IRB application, we will be conducting a pilot and feasibility trial to address the following specific aims:
1. To establish the feasibility of the LIFE program as a large-scale funded project, including participant engagement in the intervention and all study visits.
2. To evaluate the feasibility of the LIFE program in achieving weight maintenance and postpartum weight loss targets in obese pregnant women across all three obesity classes.
3. To develop and refine the study materials for the LIFE program and assessment battery.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: