跳至主要内容
临床试验/NCT01168765
NCT01168765已完成不适用

Tu Salud Si Cuenta: UT Community Outreach Program for Community-based Diabetes Prevention and Control

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2010年6月1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
500
试验地点
2
主要终点
Outcome of Physical Activity

研究概览

简要总结

Building from existing intervention strategies designed for the Mexican American population entitled Tu Salud Si Cuenta(TSSC) or Your Health Matters. This intervention highlights in the media successful role models who have changed their food choices and physical activity levels. In addition, the intervention designs environmental changes to help community members carry out recommended behavior change strategies. The purpose of this study is to test the efficacy of the outreach elements of the Tu Salud Si Cuenta (TSSC) media campaign, a physical activity and healthful food choice intervention among Mexican Americans in the Lower Rio Grande Valley to achieve behavioral and clinical outcomes.

详细描述

The proposed intervention research study is building from existing intervention strategies designed for the Mexican American population entitled Tu Salud Si Cuenta (TSSC) or Your Health Matters. This intervention highlights in the media successful role models who have changed their food choices and physical activity levels. In addition the intervention designs environmental changes to help community members carry out recommended behavior change strategies. Outcomes of interest for this study include increased physical activity so as to achieve the CDC/ACSM recommendations of 150 minutes of moderate to vigorous physical activity each week (Haskell et al., 2007), eating 5 servings of fruits and vegetables each day, reducing food portion sizes, and subsequent changes in biomarkers of health.

To test the efficacy of the outreach components of this campaign we are proposing a behavioral intervention trial with two study arms: 1) media campaign or 2) media campaign plus promotora outreach. Data will be collected from the 500 newly enrolled members of the Cameron County Hispanic Cohort, each member from a different household and primarily from quartiles two and four. The measures of this group will be the standard measures collected from the cohort including their medical history, clinical measures and behavioral measures. Two additional measures specified in this proposal will be obtained.

Participants assigned to the TSSC media campaign-only arm of the study will receive a welcome TSSC newsletter upon enrollment to the study, and will receive the same exposure to the TSSC media campaign as other community members not enrolled in the behavioral intervention trial. This includes exposure to the campaign when at the Clinical Research Unit for CCHC data collection via possible viewing of TSSC television segments in the waiting area, and availability of TSSC newsletters. Other possible TSSC campaign exposure will occur as it does for the general public via radio, television and website, using the walking trials, going to farmers market, etc.

Participants assigned to the Promotora plus arm of the study will also receive the initial welcome TSSC newsletter, and other media campaign materials to assure that they are aware of the various media outlets and programming of the campaign. In addition, they will receive a promotora home visit within two weeks of their enrollment. The home visit will consist of the promotora delivering that month's TSSC newsletter, reviewing the newsletter with the participant, emphasizing the role model story, discussing physical activity and healthful food choices using motivational interviewing strategies. These strategies allow the community member to discuss their own goals for making change on these issues while the promotora reflectively listens and summarizes their comments. During the home visit, the promotora will also invite the participant to relevant and accessible opportunities for physical activity and healthful food choices, such as neighborhood walking groups, exercise classes, Farmers' Market, nutrition and cooking classes. Subsequently a monthly home visit will be made by a promotora to deliver the TSSC newsletter, and to follow-up on the initial conversation and referrals. Monthly visits will be made to all 250 participants in the promotora plus arm of the study. Other tools and resources the promotoras might use at the home visits might include showing the participant how to access recipes and resources on the TSSC website, viewing relevant TSSC TV clips on a laptop. Participants will also be invited to an annual celebration of the TSSC media campaign which will feature speakers, cooking and exercise demonstrations and opportunities for networking.

The purpose of this study is to test the efficacy of the outreach elements of the Tu Salud Si Cuenta (TSSC) media campaign, a physical activity and healthful food choice intervention among Mexican Americans in Lower Rio Grande Valley, to achieve behavioral and clinical outcomes.

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mexican American men and women aged between 18-75 years old are eligible. All participants of the Behavioral Intervention Trial will first be newly enrolled participants in the Cameron County Hispanic Cohort(CCHC). Persons involved in other intervention studies are eligible to be included in this study as well.

排除标准

  • Mexican American men and women older than 75 years or younger than 18 years will be excluded. Persons not enrolled in CCHC will be excluded.

结局指标

主要结局

Outcome of Physical Activity

时间窗: minutes of physical activity obtained in last 7 days

Minutes of physical activity obtained during last 7 days and examined annually by study groups over time.

Outcome of Fruit and Vegetable intake

时间窗: servings of fruits & vegetables consumed daily

serving of fruits and vegetables consumed daily as determined by pictures of serving sizes and examined annually

Biomarkers

时间窗: assessed annually by study groups over time

Biomarkers measured by standardized clinical measurement, as in blood pressure, fasting blood glucose, etc., and assessed annually.

次要结局

  • Diabetes knowledge(assessed annually by a measured score on diabetes knowledge survey)
  • Quality adjusted life years(assessed annually at examination)

研究者

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

Belinda Reininger

Associate Professor, Health Promotion and Behavioral Sciences

The University of Texas Health Science Center, Houston

研究点 (2)

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