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临床试验/NCT00810342
NCT00810342已完成3 期

Physical Activity in Women With Infants

University of Hawaii2 个研究点 分布在 1 个国家目标入组 311 人开始时间: 2008年4月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
311
试验地点
2
主要终点
Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months

研究概览

简要总结

This is a study testing ways to motivate new mothers to become more physically active over a one year period.

详细描述

Mothers of an infant are much less likely to exercise regularly compared with women who have older children or no children. This low level of physical activity (PA) contributes to postpartum weight retention which can predict levels of obesity up to 15 years later. Ethnic minorities have higher rates of inactivity and gain more weight following childbirth, which places them at increased risk for cancer and other chronic diseases consistent with known health disparities for these ethnic groups. Few PA interventions have been designed to increase PA in women with an infant, especially ethnic minority women. This study will test the efficacy of a tailored intervention to increase and maintain PA in a multiethnic population of 268 young, healthy postpartum women living in Hawaii. Women will be recruited from health care settings, mother/baby support groups, and from the media campaigns(TV, radio, newspaper, parents magazines). Subjects will be randomly assigned to either a tailored postpartum counseling intervention on PA or standard care for PA. The tailored PA intervention will address key personal, social, and environmental factors derived from Social Cognitive Theory and the Transtheoretical Model. Also, multimodal contacts (telephone, e-mail, website) will be used to deliver theoretically-derived, culturally sensitive PA counseling,behavioral skills training (e.g., goal setting), and local resources/referrals tailored to a mother with an infant. The standard care condition receives American Heart Association/American College of Sports Medicine print materials/e-mails and referral to PA internet resources.

The primary PA outcome is minutes of moderate/vigorous physical activity (MVPA) per week, as measured by the Active Australia Questionnaire, with validation by accelerometers worn by all subjects. Condition differences in the initiation of PA will be tested at 6 and 12 months post-baseline. Key psychosocial, physiological, and cultural factors will be tested as mediators or moderators of PA, for example: self-efficacy, social support, processes of change, ethnicity, BMI, and cultural values. This study will serve as a model for the design and implementation of PA interventions for at-risk ethnic minority postpartum women.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • mother of infant aged 2-12 months
  • sedentary
  • healthy, able to do moderate intensity physical activity
  • BMI = 18.5-40
  • not planning to become pregnant in next year
  • woman aged 18-45
  • able speak and read English

排除标准

  • planning to leave Oahu, Hawaii in the next year (permanently move away)
  • a diagnosis of cancer, coronary heart disease (including atrial fibrillation), insulin-dependent diabetes mellitus (IDDM), and other atherosclerotic cardiovascular diseases (e.g., stroke),

结局指标

主要结局

Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months

时间窗: 12 months

Self reported minutes of moderate or vigorous physical activity per week after 12-months

次要结局

  • Accelerometer Collected Moderate to Vigorous Physical Activity(12-Months)

研究者

发起方
University of Hawaii
申办方类型
Other
责任方
Sponsor

研究点 (2)

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Physical Activity in Women With Infants | 临床试验