Incentives Targeting Gestational Weight Gain in Overweight/Obese Low Income Women

Completed · Not applicable

Conditions studied: Overweight, Obesity, Pregnancy

In brief

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.

Key facts

Study ID

NCT02233673

Run by

University of Vermont

People needed

136

Starts

2014-03-01

Expected to finish

2017-08-28

Last updated by the study team

2018-10-15

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

You may not qualify if…

• Major fetal congenital or chromosomal anomaly
• Women with a restricted diet (i.e., celiac disease, prior bariatric surgery, Phenylketonuria, or other metabolic disorder)

Where it is running

• University of Vermont — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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