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临床试验/NCT01425645
NCT01425645已完成不适用

Families Defeating Diabetes: Canadian Intervention for Family-Centered Diabetes Prevention Following Gestational Diabetes (GDM)

Lawson Health Research Institute2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2012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
已完成
入组人数
180
试验地点
2
主要终点
Proportion of study subjects achieving a 7% weight loss

研究概览

简要总结

No evidence-based, evaluated, population-appropriate resources exist to translate Type 2 diabetes (T2DM) primary prevention messages to Canadians. Significant barriers to such large-scale interventions include:

  • the need to identify, then target specific at-risk populations
  • significant time-delays before any program effects on T2DM incidence may manifest.

However, women with gestational diabetes (GDM) are a readily identifiable study cohort at significant risk for recurrent GDM and T2DM-hence GDM women provide important opportunities for rigorous, timely diabetes prevention intervention studies. The investigators propose FDD (Families Defeating Diabetes), a Canadian diabetes prevention intervention uniquely targeting women with recent GDM in the context of their families.

FDD is a 12 month, randomized, controlled T2DM prevention intervention targeting women with recent GDM, within their family context. Five Canadian sites and 177 women will participate. Multifaceted information and behavioural change support will be provided for diet, weight loss, and activity through: seminar, walking groups, electronic updates, password-protected social networking site.

Subjects and controls will be compared for: DM prevention knowledge; diet/activity choices; HbA1C; body habitus at study onset/during study/12 months/24 months.

Consenting immediate family members will have protective knowledge/diet/exercise choices/body habitus measures documented at study onset/12 and 24 months.

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • women aged 18-50 with recent GDM
  • able to speak and write English
  • overweight (BMI >25 before pregnancy)
  • significant other family members

排除标准

  • women with Types 1 or 2 diabetes
  • women with BMI under 25

研究组 & 干预措施

Lifestyle and behavioural change support

Active Comparator

Interventional arm will be offered a 12 month lifestyle program translating DM prevention issues to the family milieu

干预措施: FDD program (Other)

control

No Intervention

Control arm will receive standard diabetes prevention care as outlined in the current Canadian diabetes association Clinical Practice Guidelines.

结局指标

主要结局

Proportion of study subjects achieving a 7% weight loss

时间窗: one year post-partum

Weight loss in intervnetional vs control women will be documented by one year post-partum

次要结局

未报告次要终点

研究者

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

Ruth McManus

MD, FRCPC, Cert Endo, Professor of Medicine, UWO

Lawson Health Research Institute

研究点 (2)

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