Nutrition Intervention for the Promotion of Healthy Weight Gain During Pregnancy: The Revere Pregnancy Weight Management Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Percent of total weight gained during pregnancy compared to current Institute of Medicine Guidelines.
研究概览
简要总结
The purpose of this study is to determine if twice monthly interaction with a registered dietitian from 6-16 weeks gestation through 6 months postpartum will help women who are overweight or obese gain weight during pregnancy closer to the Institute of Medicine (IOM)guidelines and lose weight more effectively within the 6 month postpartum period than those who do not receive twice monthly interaction with a registered dietitian during this period.
Overweight/obesity can lead to a number of adverse pregnancy, delivery and birth outcomes, including increased risk of hypertension, eclampsia, and diabetes during pregnancy, miscarriage, premature delivery, birth injuries, neural tube defects, and prenatal death. More than half of women of childbearing age are overweight or are obese. Women of color and low-income women are affected disproportionately.
Unfortunately, women know little, if anything, about the impact of overweight and obesity on pregnancy and health care providers are unsure how to effectively address the problem with their patients.
A limited number of programs have tested ways to effectively address weight gain management during pregnancy. None have been successful in addressing weight gain in women who are obese or overweight at the start of pregnancy. The 2-year Revere Health Center Pregnancy Weight Management Study will test the feasibility and efficacy of providing pregnant women who are overweight or obese with regular access to a registered dietitian during and after pregnancy to help achieve total weight gain closer to recommended guidelines and to ensure the best outcomes for the mother and her newborn.
详细描述
The Revere Pregnancy and Weight Management Study has been designed to test the hypothesis that women with a BMI > 25 and < 40 who receive information about the risks of excessive weight gain during pregnancy and bimonthly interventions from a registered dietitian from the beginning of their pregnancy (6-16 weeks gestation) through 6 months postpartum, will achieve total weight gain closer to IOM (Institute of Medicine) guidelines and will have fewer complications as compared to women who only receive information about the risks of excessive weight gain (i.e. Current standard of optimal care). In addition, we hope to find that women who participate in the program will increase physical activity and show improvement in overall nutritious food choices as will be measured by the results of a nutrition and physical activity questionnaire completed by all participants at 3 points during the study.
This study will be managed completely by a registered dietitian who has experience working with pregnant women. The dietitian will have direct access to the participants' primary clinicians for consultation throughout the course of the study.
All patients, regardless of whether in the control or intervention group, will receive the optimal standard of prenatal and postpartum care and any additional care needed to ensure the best outcomes for the mother and newborn.
Everyone in the study will meet with the dietitian who works at the Revere Health Center at least one time. During the initial visit, participants will receive information about healthy eating and exercise during pregnancy. Women will also receive information about risks to mother and baby related to excessive weight gain during pregnancy for overweight and obese women.
Women in the control group will have no further interaction with the study dietitian.
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 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women ages 18 to 49 with a BMI >25 and <40 at the first prenatal visit
- •Women < 16 weeks gestation
- •Both women who have and have not received previous nutritional counseling
- •Both women who have and have not dieted in the past
- •Women with a documented medical history or who report a history of disordered eating including over eating, night eating, or binge eating without a diagnosis listed in the "exclusion criteria" will not be excluded
排除标准
- •Pregnant women over age 49
- •Pregnant women ages 18 to 49 with a BMI <25 or > 40 at their first prenatal visit
- •Women > 16 weeks gestation
- •Women pregnant with multiples
- •Diabetes prior to pregnancy
- •Women with a documented medical history of an eating disorder including anorexia nervosa, bulimia nervosa, anorexia athletica, and orthorexia will be excluded
结局指标
主要结局
Percent of total weight gained during pregnancy compared to current Institute of Medicine Guidelines.
时间窗: Weight at first prenatal care appointment. Weight at last obstetrical appointment prior to delivery.
次要结局
- Overall improvement of the intake of nutritious foods as quantified by a written nutrition and exercise questionnaire.(Enrollment, 6 weeks postpartum, 6 months postpartum)
- Prevalence of complications, specifically: -hypertension and eclampsia, -gestational diabetes, -caesarian delivery, -macrosomia -admission to neonatal intensive care unit (NICU)(Throughout study participation)
- Initiation of breastfeeding(6 weeks postpartum)
- Postpartum weight reduction in comparison to pre-pregnancy baseline weight (BMI)(6 month postpartum)
- Maintenance of improvements in overall intake of nutritious foods as quantified by the nutrition and exercise questionnaire(6 weeks post partum, 6 months postpartum)
- Maintenance of improvements in physical activity as quantified by the nutrition and exercise questionnaire(6 weeks postpartum, 6 months postpartum)
- Maintenance of breastfeeding(6 weeks postpartum, 6 months postpartum)
研究者
Alessandra Peccei, MD
Alessandra Peccei, MD
Massachusetts General Hospital