NCT01584063已完成不适用
Healthy Mothers on the Move
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
- 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.
- 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.
- 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.
- 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
- 否
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
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