Incentives Targeting Gestational Weight Gain in Overweight/Obese Low Income Women
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Obesity Weight Loss, Obesity Weight Loss, Women's Studies |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 10/17/2018 |
| Start Date: | March 2014 |
| End Date: | August 28, 2017 |
Excessive weight gain during pregnancy, particularly in overweight and obese women,
predisposes to adverse perinatal outcomes and has long term effects on maternal and neonatal
health. With an inverse relationship between socioeconomic status and obesity, significant
health disparities exist between obese and normal weight women. The Institute of Medicine
(IOM) recently revised its gestational weight gain recommendations, targeted to pregravid
body mass index (BMI), to minimize pregnancy complications. However, these recommendations
are based on cross sectional observational studies and neither the ideal method to achieve
weight gain goals nor whether perinatal outcome is optimized with active management of weight
gain is known. The investigators propose to investigate a behavioral incentive-based
intervention to improve compliance with IOM weight gain recommendations during pregnancy in
low-income overweight and obese women. The investigators will evaluate if 1) gestational
weight gain can be reliably targeted to the IOM recommendations and 2) active weight gain
management during pregnancy improves perinatal outcomes. Two study groups will be compared in
a prospective randomized trial; 1) those receiving standard obstetrical care and 2) those
receiving behavioral weight management counseling plus financial incentives for achieving
weight gain goals. The main outcome measure will be the percentage of women gaining within
the IOM recommendations based on prepregnancy BMI. Secondary outcomes evaluated will include
fetal growth and body composition changes, birth weight and the rate of cesarean delivery.
The investigators hypothesize that 1) the behavioral intervention with incentives will result
in greater compliance to IOM guidelines for gestational weight gain than standard care and 2)
targeting weight gain to the IOM guidelines will lead to a reduction in the rates of fetal
macrosomia and cesarean delivery. Finally, cost effectiveness of treatment conditions will be
examined. This intervention, if efficacious and cost-effective, has the potential to improve
compliance with gestational weight gain guidelines, optimize perinatal outcomes, and reduce
health disparities.
predisposes to adverse perinatal outcomes and has long term effects on maternal and neonatal
health. With an inverse relationship between socioeconomic status and obesity, significant
health disparities exist between obese and normal weight women. The Institute of Medicine
(IOM) recently revised its gestational weight gain recommendations, targeted to pregravid
body mass index (BMI), to minimize pregnancy complications. However, these recommendations
are based on cross sectional observational studies and neither the ideal method to achieve
weight gain goals nor whether perinatal outcome is optimized with active management of weight
gain is known. The investigators propose to investigate a behavioral incentive-based
intervention to improve compliance with IOM weight gain recommendations during pregnancy in
low-income overweight and obese women. The investigators will evaluate if 1) gestational
weight gain can be reliably targeted to the IOM recommendations and 2) active weight gain
management during pregnancy improves perinatal outcomes. Two study groups will be compared in
a prospective randomized trial; 1) those receiving standard obstetrical care and 2) those
receiving behavioral weight management counseling plus financial incentives for achieving
weight gain goals. The main outcome measure will be the percentage of women gaining within
the IOM recommendations based on prepregnancy BMI. Secondary outcomes evaluated will include
fetal growth and body composition changes, birth weight and the rate of cesarean delivery.
The investigators hypothesize that 1) the behavioral intervention with incentives will result
in greater compliance to IOM guidelines for gestational weight gain than standard care and 2)
targeting weight gain to the IOM guidelines will lead to a reduction in the rates of fetal
macrosomia and cesarean delivery. Finally, cost effectiveness of treatment conditions will be
examined. This intervention, if efficacious and cost-effective, has the potential to improve
compliance with gestational weight gain guidelines, optimize perinatal outcomes, and reduce
health disparities.
Inclusion Criteria:
-≥18 years of age and ≤ 45 years of age
-≤16 weeks gestation
- BMI ≥25
- Ultrasound documented viable singleton intrauterine pregnancy
- English speaking
- Planning to deliver at Fletcher Allen Health Care
- Willing to be randomized to one of the study groups
- Written informed consent
Exclusion Criteria:
- Major fetal congenital or chromosomal anomaly
- Women with a restricted diet (i.e., celiac disease, prior bariatric surgery,
Phenylketonuria, or other metabolic disorder)
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