An interventional study of Financial incentives in Overweight, Obesity and Pregnancy, sponsored by University of Vermont. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-10-15.
Sponsored by University of Vermont · Not applicable, Interventional, and Prevention
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 136 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
-≥18 years of age and ≤ 45 years of age
-≤16 weeks gestation
Exclusion Criteria:
Participants receive behavioral intervention and financial incentives for meeting gestational weight gain goals
Behavioral: Financial incentives
Participants receive standard obstetrical care from their provider
Participants receive a behavioral intervention and financial incentives for meeting gestational weight gain goals.
Gestational weight gain within the Institute of Medicine guidelines
Total gestational weight gain at time of last prenatal visit. For participants in the intervention arm, gestational weight gain at 2 week intervals will also be assessed.
Time frame: At time of delivery
Cesarean delivery rate
Cesarean delivery rate (as a percent of total deliveries) will be assessed
Time frame: Time of delivery
Fetal macrosomia
Fetal weight at delivery will be recorded. Percent fetal macrosomia (birthweight \>4000g) will be assessed.
Time frame: At delivery
Cost of intervention
Costs to the patient attending the intervention (transportation, childcare, missed wages) will be calculated against cost differences in outcomes.
Time frame: Intake to 6 weeks postpartum
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University of Vermont