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临床试验/NCT03196570
NCT03196570已完成不适用

Increasing Physical Activity in Latino Men Through Tailoring

University of Connecticut2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change in Physical Activity from Baseline to 6 months

研究概览

简要总结

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.

详细描述

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 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Change in Physical Activity from Baseline to 6 months

时间窗: Baseline and 6 months

Minutes of Moderate and Vigorous Physical Activity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kim Gans

Professor

University of Connecticut

研究点 (2)

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Increasing Physical Activity in Latino Men | 临床试验