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临床试验/NCT01803698
NCT01803698撤回不适用

MANAGEMENT OF GESTATIONAL WEIGHT GAIN BY FAMILY PHYSICIANS: SEEKING CONGRUENCE WITH GUIDELINES

Helena Piccinini1 个研究点 分布在 1 个国家开始时间: 2017年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Congruence with gestational weight gain guidelines

研究概览

简要总结

Background The Institute of Medicine (IOM) published guidelines in 2009 for optimal gestational weight gain (GWG) during pregnancy. These guidelines include trajectories for optimal GWG, based on a woman's pre-pregnancy body mass index (BMI), to be used throughout the duration of a pregnancy. Although there is a significant association between the total GWG recommended by these guidelines and maternal and perinatal outcomes, research has demonstrated that only approximately one-third of pregnant women have total GWG within the recommended amounts. Factors known to influence GWG include maternal age, parity, being in a committed relationship and smoking. In addition, recommendations by primary care providers have been shown to influence actual GWG. Women appreciate advice from their primary care providers, however, despite this, there is evidence that many patients report not being advised at all about GWG by their primary care providers.

Relevance Excess weight gain in pregnancy has been shown to be a modifiable risk factor for excess weight in childhood, thus contributing to the intergenerational cycle of obesity. There is an opportunity to interfere with this cycle during the peri-pregnancy period, as women's motivation to engage in behaviour change is elevated and contact with their primary care providers is frequent.

Research Question and Hypothesis What impact does training family physicians to regularly refer to the IOM trajectories and provide feedback about GWG ("training in the use of IOM charts") during routine prenatal visits, compared to usual care, have on congruence of total GWG with IOM guidelines? Null Hypothesis: there is no difference in the congruence of total GWG with IOM guidelines between women whose family physicians were assigned to training in the use of the IOM charts and those whose family physicians were assigned to usual care.

Objectives

The following are the objectives for this study:

  1. To compare the congruence of total GWG with IOM guidelines between women whose family physicians were assigned to training in the use of IOM trajectories and those whose family physicians were assigned to usual care.
  2. To explore the relationship between other independent variables (maternal age, parity, committed relationship and smoking) and congruence of total GWG with IOM guidelines, for women whose family physicians were assigned to training in the use of IOM trajectories and for those whose family physicians were assigned to usual care.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • family physicians who provide prenatal care
  • pregnant women with low risk pregnancy

排除标准

  • pregnant women < 18 years old
  • pregnant women with multiple gestation
  • pregnant women with chronic disease
  • pregnant women initially presenting in second trimester or later.

研究组 & 干预措施

Training in the use of IOM charts

Experimental

Training family physicians to regularly refer to the Institute of Medicine guideline trajectories and provide feedback about GWG ("training in the use of IOM charts") during routine prenatal visits.

干预措施: Training in the use of IOM charts (Behavioral)

Usual care

No Intervention

Family physicians providing usual prenatal care.

结局指标

主要结局

Congruence with gestational weight gain guidelines

时间窗: up to 38 weeks after enrolment

The congruence of total gestational weight gain with Institute of Medicine guidelines based on pre-pregnancy body mass index.

次要结局

未报告次要终点

研究者

发起方
Helena Piccinini
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Helena Piccinini

Family Physician

Nova Scotia Health Authority

研究点 (1)

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