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临床试验/NCT02690766
NCT02690766已完成不适用

Translating Healthy Lifestyle Interventions for Breast and Endometrial Cancer Survivors With Diabetes

University of North Carolina, Chapel Hill0 个研究点目标入组 17 人开始时间: 2015年3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
17
主要终点
Change in Body Weight

研究概览

简要总结

Investigators proposed to refine and test the feasibility and acceptability of a 4-month multi-modal lifestyle intervention in African American female breast or endometrial cancer survivors diagnosed with type 2 diabetes.

详细描述

Recent systematic reviews and meta-analyses of cohort studies show that physical activity can reduce mortality and morbidity in diabetes and obesity-related cancers. Yet, there have been few efforts to promote physical activity within the context of female cancer survivorship, particularly among women with diabetes. In response, investigators proposed to refine and test the feasibility and acceptability of a 4-month multi-modal lifestyle intervention in African Americans (AA) with diabetes and who are breast or endometrial cancer survivors. This web-based, lifestyle intervention, coupled with coaching calls and in-person exercise sessions, may be an effective way to promote physical activity and healthy survivorship. The primary goal is for participants to participate in 30 minutes of moderate-to-vigorous physical activity five times a week. The investigators' aims : i) refine a theory-driven healthy lifestyle intervention, that is delivered via computer technologies and periodic in-person group exercise sessions with appropriate content, literacy demand and graphics, ii) assess the preliminary effects of the intervention on the primary outcome of level of moderate to vigorous physical activity (MVPA), as measured by accelerometry; weight, glycosylated hemaglobin and evaluate the effect of eating behaviors, wellbeing/functioning (quality of life, depressive symptoms, self-efficacy), compliance/adherence to protocol and acceptability on response to the intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
30 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • African American women, ages 30
  • No evidence of pregnancy, as evidenced by negative urine pregnancy test.
  • Diagnosed with type 2 diabetes by their provider
  • Diagnosed with Stage I-III breast or endometrial cancer
  • Completed treatment for breast or endometrial cancer at least 4 months and no more 5 years ago English-speaking
  • Agree to participate in all aspects of the semi-structured interview (Aim 1)
  • Agree to participate in all aspects of the feasibility study, including group sessions (Aim 2)
  • Access to the internet via phone or computer
  • Access to a working phone for personal use

排除标准

  • Non-English speaking
  • Recent epilepsy, cardiac event or stroke in last 6 months,special nutritional needs (e.g. current evidence of malignancy; HIV)
  • History of epilepsy, cardiac event or stroke within the last year
  • Known diagnosis of HIV
  • Known new malignancy
  • Less than 4 months or more than 2 years post treatment of Stage I-III breast or endometrial cancer.
  • No diagnosis of type 2 diabetes
  • No self-report of African American race/ethnicity
  • No access to a phone for personal use
  • No access to the internet via computer or mobile phone

结局指标

主要结局

Change in Body Weight

时间窗: Week 0 and 16

Body weight in pounds will be measured on a digital scale to assess change in body weight over the 16-week intervention period

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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