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临床试验/NCT02233673
NCT02233673已完成不适用

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

University of Vermont2 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2014年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
136
试验地点
2
主要终点
Gestational weight gain within the Institute of Medicine guidelines

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ≥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

排除标准

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

研究组 & 干预措施

Behavioral, incentives

Experimental

Participants receive behavioral intervention and financial incentives for meeting gestational weight gain goals

干预措施: Financial incentives (Behavioral)

Standard care

No Intervention

Participants receive standard obstetrical care from their provider

结局指标

主要结局

Gestational weight gain within the Institute of Medicine guidelines

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julie Phillips

Project Director

University of Vermont

研究点 (2)

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