Texting for Mobility in Overweight/Obese Adults With Peripheral Artery Disease

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追踪信息

首次提交日期 ^ICMJE

October 1, 2018

首次发布日期e ^ICMJE

October 3, 2018

最后更新发布日期

October 3, 2018

预计研究开始日期 ^ICMJE

October 2018

预计主要完成日期

April 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Walking distance[ Time Frame: Change from Baseline to Month 3 ]

Change in walking distance as measured by the 6 minute walk test.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Weight loss[ Time Frame: Change from Baseline to Month 3 ]
Change in weight
Quality of life (QoL)[ Time Frame: Change from Baseline to Month 3 ]
Change in QoL as measured by the VascQOL.
Physical activity[ Time Frame: Change from Baseline to Month 3 ]
Physical activity to be measured using the Exercise Behaviors Questionnaire.
Dietary habits[ Time Frame: Month 3 ]
Dietary habits tracked using the Diet History Questionnaire.

描述性信息

简略标题 ^ICMJE

Texting for Mobility in Overweight/Obese Adults With Peripheral Artery Disease

正式标题 ^ICMJE

Text Messaging to Promote Mobility in Overweight/Obese Adults With Peripheral Artery Disease

简要概况

By doing this study, researchers hope to learn about the impact of text messaging to help overweight or obese adults with PAD lose weight and improve their walking distance.

详细说明

Peripheral artery disease (PAD) or poor leg circulation affects 8 to 12 million Americans including non-Hispanic Whites, African Americans and Latinos. Having PAD can limit how far you can walk. Many patients with PAD are also overweight or obese. Weight loss among overweight or obese adults with PAD may improve walking distance. Given how common obesity or being overweight is among persons with PAD, interventions are needed to address weight loss in this population.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Prevention

适用条件 ^ICMJE

干预项目 ^ICMJE

Behavioral: PACE
Patient-centered Assessment and Counseling for Exercise [PACE] program
Behavioral: Diet
Motivating healthy dietary habits
Other: App
Using an app to deliver communication to the participant.
Other: Face-to-face
Using in person meetings and/or phone communication with the participant.

研究工具

Experimental: PACE+DApp
Participants in this group will receive combined intervention and a mobile phone app.
Active Comparator: PACE+Dface-to-face
Participants in this group will receive combined intervention and in person/phone communication.

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

April 2019

预计主要完成日期

April 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Overweight or obese (body mass index >=27 kg/m2) - Have symptomatic PAD - English or Spanish speaking - Have 24 hour access to a cell phone Exclusion Criteria: - Cannot tolerate fruits and vegetables, fiber, and/or a low fat diet, as informed by a physician and/or registered dietician - Restricted intake of water - Pregnancy - Prior major amputation (foot or lower leg) or critical leg ischemia (tissue loss, gangrene, or ulcers) - Use of supplemental oxygen - Heart attack within preceding 3 months

性别

参与研究的性别:

All

年龄

最小年龄：21 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

University of Kansas Medical Center

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Traci Collins, MD, MPH University of Kansas Medical Center

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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