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临床试验/NCT02872402
NCT02872402进行中(未招募)不适用

Feasibility of a Lifestyle Intervention Early After Delivery on the Cardiometabolic Risk Profile of Women With Recent Gestational Diabetes

Laval University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
1
主要终点
Weight retention

研究概览

简要总结

The goal of the study is to investigate the effect of a lifestyle intervention program (adoption of exclusive breastfeeding, healthy diet and regular physical activity) on minimizing postpartum weight retention among women with recent GDM.

详细描述

Women with a history of gestational diabetes (GDM) are characterized by increased risk for subsequent type 2 diabetes (T2D) and cardiovascular disease (CVD). These women are also characterized by higher body mass index (BMI) and waist circumference compared to women without prior GDM. Failure to lose the weight gained during pregnancy can lead to increased BMI for subsequent pregnancies. As such, the childbearing-age period has been described as a potential period of weight gain and represents a critical window for the development of obesity, T2D and CVD. Therefore, strategies aiming at preventing postpartum weight retention (WR) and early cardiometabolic alterations in women with a history of GDM are of paramount importance. Principal investigator have shown that a low diet quality score was associated with greater adiposity and lower insulin sensitivity in women with prior GDM. Furthermore, less than 10% of women with prior GDM met the recommendations for breastfeeding, nutrition, and physical activity. Investigators have shown that attitude and perceived behavioral control were significant predictors of the intention to adopt healthy eating. For those who did engage in healthy behaviors, lower prevalence of cardiometabolic alterations was observed, providing supportive evidence that the adoption of healthy behaviors may be key to prevent the progression to an altered cardiometabolic profile.

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 (Investigator)

入排标准

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

入选标准

  • •Pregnant women diagnosed with GDM
  • •Fluent in French
  • •Had a singleton pregnancy
  • •At least 18 yrs old
  • •With a reported pre-pregnancy BMI ≥18.5 kg/m2

排除标准

  • •Women who had bariatric surgery
  • •Women who plan another pregnancy in the following year
  • •Women with a history of type 1 or type 2 diabetes
  • •Women with a multiple pregnancy

研究组 & 干预措施

Intervention group

Experimental

At 2-mo postpartum, women will start the 1-yr lifestyle intervention that will consist of 7 face-to-face individual sessions of 1-hr (at 2, 3, 4, 5, 6, 9, 12 mo postpartum and a follow-up at 18 mo). Metabolic and anthropometric measurements will be assessed at 2,6,12 and 18 mo postpartum. In addition, 7 individual sessions of 30 min between face-to-face sessions will be carried out on the phone.

Benefits of exclusive breastfeeding, healthy eating and physical activity will be portrayed at each visit .

干预措施: Lifestyle intervention (Behavioral)

Active control lifestyle intervention

Active Comparator

Women in the control group will come to the testing unit at 2, 6, 12 and 18 mo postpartum for metabolic and anthropometric measurements and at 3, 4, 5, 9 mo for weight measurements only. They will receive standard lifestyle recommendations in the form of written information at each visit.

干预措施: Active control lifestyle intervention (Behavioral)

结局指标

主要结局

Weight retention

时间窗: 12 months postpartum

次要结局

  • Body composition(12 months postpartum)
  • Insuline(12 months)
  • Healthy eating index(12 months)
  • Glucose(12 months)
  • Glycated hemoglobin(12 months)
  • Resting blood pressure(12 months)
  • Time physically active(12 months)
  • Waist circumference(12 months postpartum)
  • Oral glucose tolerance test (75g)(12 months)
  • Lipid profile(12 months)
  • Breastfeeding duration(12 months)

研究者

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

Julie Robitaille

Associate Professor

Laval University

研究点 (1)

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