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Clinical Trials/NCT02233673
NCT02233673
Completed
Not Applicable

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

University of Vermont1 site in 1 country136 target enrollmentMarch 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overweight
Sponsor
University of Vermont
Enrollment
136
Locations
1
Primary Endpoint
Gestational weight gain within the Institute of Medicine guidelines
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
August 28, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julie Phillips

Project Director

University of Vermont

Eligibility Criteria

Inclusion Criteria

  • ≥18 years of age and ≤ 45 years of age
  • ≤16 weeks gestation
  • 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)

Outcomes

Primary Outcomes

Gestational weight gain within the Institute of Medicine guidelines

Time Frame: At time of delivery

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.

Secondary Outcomes

  • Cesarean delivery rate(Time of delivery)
  • Fetal macrosomia(At delivery)

Study Sites (1)

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