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临床试验/NCT01584063
NCT01584063已完成不适用

Healthy Mothers on the Move

University of Michigan0 个研究点目标入组 276 人开始时间: 2004年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
276
主要终点
Physical Activity

研究概览

简要总结

Healthy Mothers on the Move (Healthy MOMs), was a prospective randomized controlled trial that aimed to demonstrate the effectiveness of a healthy lifestyle intervention to reduce risk factors for obesity and type 2 diabetes. This behavioral intervention was tailored to the needs of pregnant and postpartum Latino women. This study was conducted between 2004 and 2006 in southwest Detroit.

详细描述

Specific Aims

  1. Intervention group participants will have improved levels of protective behaviors (improved daily dietary composition and increased level of physical activity) that reduce the risk of type 2 diabetes compared to control group.
  2. Intervention group participants will have improved their status on clinical measures of risk for type 2 diabetes (anthropometric and metabolic status) compared to the control group.
  3. To assess whether theory-based variables, including changes in attitudes, behavioral and control beliefs, perceived social support and behavioral intention change from baseline, and whether these changes influence behavioral outcomes.
  4. To identify aspects of project planning and implementation that contributed to achievement of behavioral and clinical outcomes. Measures include recruitment, retention and intervention participation rates, barriers and facilitators of participation; and community involvement in, and satisfaction with, intervention components and project activities; and fidelity of intervention components.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • 18 years of age or older
  • A resident of Southwest Detroit
  • Less than 20 weeks gestational at the eligibility screening

排除标准

  • women with:
  • Type 1 or type 2 diabetes
  • Incompetent cervix/cerclage
  • Active thyroid
  • Multiple gestation
  • Cardiac, vascular or pulmonary disease
  • Drug or alcohol addiction
  • Serious physical or mental illness or condition that would substantially interfere with participation in or completion of the entire intervention

结局指标

主要结局

Physical Activity

Diet

次要结局

  • Weight (gain during pregnancy, postpartum retention)
  • Metabolic (e.g., glucose)

研究者

申办方类型
Other
责任方
Sponsor

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Healthy Mothers on the Move | 临床试验