Lifestyle Intervention Forever: Healthy Weight for Pregnancy and Birth (Pilot Study)
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Women's Studies |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 4/21/2016 |
| Start Date: | September 2012 |
| End Date: | July 2015 |
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.
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.
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.
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.
Inclusion Criteria:
- Women aged 18-40 years with a confirmed singleton pregnancy of up to 18 weeks
gestation
- Pre-pregnancy or early pregnancy BMI greater than or equal to 30 kg/m2
Exclusion Criteria:
- Aged < 18 years or > 40 years
- BMI < 30 kg/m2 at study screening
- Multiple gestations
- Previously diagnosed with type 1 or type 2 diabetes mellitus
- Subjects will be excluded from the study if they present with any absolute or
relative contraindications to exercise in pregnancy (as defined by ACOG); determined
by completion of medical questionnaire by supervising physician
- Any evidence of:
i. Drug or alcohol abuse ii. Presence of any unstable psychiatric disorder iii. Plans
to move away from the geographical area within the next nine months iv. Other medical
or behavioral factors that, in the judgement of the supervising physician, may
interfere with their ability to take part in a lifestyle intervention program during
pregnancy.
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