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| ID | Type | Description | Link |
|---|---|---|---|
| 8485 | Other Identifier | SLU eRS | |
| 22009 | Other Identifier | SLU IRB |
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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.
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:
To establish an effective contingency management behavioral program (LIFE), increasing adherence to nutritional recommendations and exercise guidelines during pregnancy.
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.
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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle intervention group | Experimental | The LIFE program emphasizes improved nutritional quality, moderate physical activity, and weight maintenance (±10 lb) in obese pregnant women using a contingency management (CM) approach to reinforce behavior change. Participants will meet with the study dietitian and exercise physiologist every 2-4 weeks to develop and maintain individualized nutrition and physical activity plans, reinforced by CM. When the subject meets with the interventionists at their regular appointments, they will review the diet and exercise requirements, and provide vouchers earned as reinforcement from the previous study period. Diet requirements include at least 5 days of food logs each week. Exercise requirements include objective verification of up to 5 exercise sessions per week (as prescribed). |
|
| Routine care group | No Intervention | Participants in the Routine Care (RC) control group will receive no additional intervention beyond standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Gestational weight gain from study entry to delivery | Maternal weight (lb) will be measured at program entry and at the time of delivery to determine weight gain during the study period. Pre-pregnancy body weight will be self-reported and used to estimate total gestational weight gain (lb). | Approx. 20-25 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measure Change from baseline in maternal body composition | Changes in lean and fat mass will be examined at study entry, in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum | 16-21 weeks |
| Measure Change from baseline in maternal aerobic capacity |
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Inclusion Criteria:
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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| Name | Affiliation | Role |
|---|---|---|
| Rosemary Catanzaro | St. Louis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Louis University | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Peak aerobic capacity will be examined via a standard maximal oxygen consumption (VO2max) test performed on a stationary cycle ergometer at study entry, in late pregnancy (34-36 weeks gestation), and at 12 weeks postpartum |
| 16-21 weeks |
| Measure Maternal hormonal/metabolic changes from baseline | A fasted blood sample will be collected at study entry, in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum to examine changes in lipid profile and adipokines (TNF-alpha, leptin). Fasting glucose, insulin and C-peptide will also be measured and entered into the homeostatic model (HOMA) to estimate changes in insulin sensitivity and beta cell function during the study period. | 16-21 weeks |
| Number of participants with Obstetric complications | Parameters examined will include:
| 1-25 weeks |
| Change from baseline in maternal dietary intake | Dietary intake will be examined at study entry (15-18 weeks gestation), in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum. | 16-21 weeks |
| Measure Change from baseline in maternal psychometric outcomes | Psychometric outcomes examined at study entry, in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum include:
| 16-21 weeks |
| Measure Offspring - fetal growth | Fetal growth and abdominal circumference will be examined by fetal ultrasound at approximately 28-30, 34-36 and 38-40 weeks gestation and/or as part of routine care after 28 weeks gestation. | 10-25 weeks |
| Measure Neonatal size at birth | Between group comparisons of birth size will include birth weight (g), crown-heel length (mm), head circumference (mm), body mass index (kg/m2), ponderal index. Population-specific standard deviation (SD) scores will be calculated and the incidence of small for gestational age, appropriate for gestational age and large for gestational age will be compared between groups. | Within 48 hours of birth |
| Measure Neonatal body composition at birth | Neonatal lean and fat mass (g) will be calculated based on anthropometric measurements performed within 48 hours after birth | Within 48 hours of birth |
| Measure Offspring metabolic markers | Concentrations of insulin-like growth factor (IGF)-I, IGF-II, IGF binding protein-1, IGF binding protein-3, glucose, insulin, leptin and triglyceride will be examined from cord blood samples taken at the time of delivery. | 20-25 weeks |
| Measure Pilot study outcomes | The following pilot and feasibility outcomes will be assessed:
| 32-37 weeks |
| Measure Postpartum weight retention at 12 weeks postpartum | Maternal weight (lb) will be measured at 6 & 12 weeks postpartum and compared to delivery weight (lb) to determine postpartum weight retention. | 12 weeks |
| Measure Change from baseline in maternal physical activity levels | Physical activity levels will be examined at study entry (15-18 weeks gestation), in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum. | 16-21 weeks |
| Measure Infant size at 12 weeks of age | Between group comparisons of body weight (g), length (mm), head circumference (mm), body mass index (kg/m2), and ponderal index. Population-specific SD scores will be calculated and compared between groups. | 12 weeks |
| Measure Infant body composition at 12 weeks of age | Infant lean and fat mass (g) will be calculated based on anthropometric measurements performed at 12 weeks of age. | 12 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |