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Increasing Physical Activity in Latino Men

2020年10月8日 更新者:Kim Gans、University of Connecticut

Increasing Physical Activity in Latino Men Through Tailoring

The purpose of this study is to determine the feasibility and preliminary efficacy of a web and text-messaged based intervention designed to increase physical activity among Latino men in Rhode Island. The study will also examine potential moderators of treatment effects including demographics, acculturation, and environmental variables such as the neighborhood built, social and economic environments.

研究概览

详细说明

Physical Activity in Latino Men Through Tailoring is an individually randomized web and text message based pilot study, designed to increase physical activity amongst Latino men. The study is conducting formative research with a diverse population of Latino men to inform the adaptation of the Pasos Hacia La Salud web-based intervention, which was developed for Latina women, to an intervention focused on Latino men. Consideration will also be taken to ensure intervention material is culturally appropriate for Latino men of Caribbean, South and Central American origin. Half the study participants will be randomized into the intervention arm and half into the comparison group. Participants in the intervention arm will have access to a website where they can complete questionnaires, receive information, log their physical activity and set goals. Participants complete monthly questionnaires to establish their stage of change toward increasing their physical activity and receive information manuals based on their current stage of change. They will also have access to tip sheets via the study website and receive reoccurring text messages reminding them to log into the website. Participants in the comparison arm will have access to a similar website with information related to nutrition and overall wellness, not including physical activity.

The primary aims of this project are (1) to conduct formative research with a diverse population of RI Latino men to adapt the existing web-based interventions and add text message-based components to complement and enhance the intervention. The second primary aim is to determine the feasibility, acceptability, and preliminary efficacy of the intervention and the study recruitment, implementation and evaluation protocols with a diverse population of Latino men. An additional exploratory aim will be to examine potential moderators of treatment effects including demographics, acculturation, and environmental variables such as the neighborhood built, social and economic environments. The hypothesis is that participants randomized to the intervention condition will have greater increases in weekly minutes of physical activity after six months than those randomized to a wellness control condition. The results of this pilot study will inform a future randomized controlled trial with Latino men to increase PA.

研究类型

介入性

注册 (实际的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Rhode Island
      • Providence、Rhode Island、美国、02912
        • Brown University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Be sedentary ( participate in moderate intensity leisure time PA two days a week for less than 30 minutes a day, or less)
  • Identify as a Latino male
  • Speak Spanish
  • Score of more than 16% on Spanish Shortened Test of Functional Health Literacy in Adults
  • Own a cell phone with texting capabilities and have internet access

Exclusion Criteria:

  • History of myocardial infarction or angina, insulin-dependent diabetes or hospitalization for diabetes in the past year, stroke, osteoarthritis, osteoporosis, orthopedic problems, or any medical condition that would make PA unsafe.
  • Planning to move from the area in the next 6 months
  • Hospitalization due to a psychiatric disorder in the past 3 years.
  • BMI of 45 or higher and/or taking any medication that may impair PA tolerance or performance.
  • If they or another family member is already enrolled in another PA or weight control study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention
After randomization into the intervention arm, participants will be instructed on how to use the Spanish language study website. During the six month intervention, they will complete online questionnaires to determine their stage of change towards increasing physical activity. A manual of information will be automatically generated based on their responses. Participants can read this information online, along with tip sheets related to increasing physical activity. On the website they can also set weekly goals and log their weekly PA. It will also include short videos with demonstrations for PA they can do at home and around their neighborhood. Information will also include community resources (community centers, public events, parks) where they can be physically active. Participants will also receive prompts and encouragement via text-message to encourage them to log into the website and continue to track their progress.
After randomization into the intervention arm, participants will be instructed on how to use the Spanish language study website. During the six month intervention, they will complete online questionnaires to determine their stage of change towards increasing physical activity. A manual of information will be automatically generated based on their responses. Participants can read this information online, along with tip sheets related to increasing physical activity. On the website they can also set weekly goals and log their weekly PA. It will also include short videos with demonstrations for PA they can do at home and around their neighborhood. Information will also include community resources (community centers, public events, parks) where they can be physically active. Participants will also receive prompts and encouragement via text-message to encourage them to log into the website and continue to track their progress.
有源比较器:Contact Control
Participants in the control arm will attend the same baseline orientation sessions and measurements as the intervention arm. After randomization into the control group, participants will complete an introductory in-person session to introduce them to a website, similar in design, with information on health topics other than physical activity, including diet and other factors associated with CVD risk. It will include information from NHLBI heart health materials for Latinos. Topics include healthy eating, increasing fruit and vegetable consumption, reducing fat and salt intake, learning about cholesterol, stress management. Participants will log onto a separate website unique to the control group and complete monthly surveys on the wellness topics and their progress. Participants will also receive prompts and encouragement text-messages to encourage them to log onto the website.
Participants in the control arm will attend the same baseline orientation sessions and measurements as the intervention arm. After randomization into the control group, participants will complete an introductory in-person session to introduce them to a website, similar in design, with information on health topics other than physical activity, including diet and other factors associated with CVD risk. It will include information from NHLBI heart health materials for Latinos. Topics include healthy eating, increasing fruit and vegetable consumption, reducing fat and salt intake, learning about cholesterol, stress management. Participants will log onto a separate website unique to the control group and complete monthly surveys on the wellness topics and their progress. Participants will also receive prompts and encouragement text-messages to encourage them to log onto the website.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Physical Activity from Baseline to 6 months
大体时间:Baseline and 6 months
Minutes of Moderate and Vigorous Physical Activity
Baseline and 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年3月12日

初级完成 (实际的)

2020年4月30日

研究完成 (实际的)

2020年6月30日

研究注册日期

首次提交

2017年6月15日

首先提交符合 QC 标准的

2017年6月20日

首次发布 (实际的)

2017年6月23日

研究记录更新

最后更新发布 (实际的)

2020年10月9日

上次提交的符合 QC 标准的更新

2020年10月8日

最后验证

2020年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • 1612001664

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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Physical Activity Intervention的临床试验

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