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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Belinda Reininger, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01168765
First received: July 21, 2010
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Diabetes, Obesity
Behavioral: Tu Salud Si Cuenta Behavioral Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Tu Salud Si Cuenta: UT Community Outreach Program for Community-based Diabetes Prevention and Control

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Outcome of Physical Activity [ Time Frame: minutes of physical activity obtained in last 7 days ] [ Designated as safety issue: No ]
    Minutes of physical activity obtained during last 7 days and examined annually by study groups over time.

  • Outcome of Fruit and Vegetable intake [ Time Frame: servings of fruits & vegetables consumed daily ] [ Designated as safety issue: No ]
    serving of fruits and vegetables consumed daily as determined by pictures of serving sizes and examined annually

  • Biomarkers [ Time Frame: assessed annually by study groups over time ] [ Designated as safety issue: No ]
    Biomarkers measured by standardized clinical measurement, as in blood pressure, fasting blood glucose, etc., and assessed annually.


Secondary Outcome Measures:
  • Diabetes knowledge [ Time Frame: assessed annually by a measured score on diabetes knowledge survey ] [ Designated as safety issue: No ]
    A diabetes knowledge survey will be administered annually and the measurement will be based on the resulting score.

  • Quality adjusted life years [ Time Frame: assessed annually at examination ] [ Designated as safety issue: No ]
    Measured according to a score on five constructs(mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and assessed annually.


Enrollment: 500
Study Start Date: June 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group
This is the promotora plus group that will receive the TSSC newsletter and exposure to the media campaign but will also receive monthly visits by promotoras/lay health workers who will review the monthly newsletter with participants, emphasize role model stories, and discuss physical activity and healthful food choices using motivational interviewing strategies.
Behavioral: Tu Salud Si Cuenta Behavioral Intervention
A behavioral intervention to assess the impact of the TSSC Media Campaign intervention outreach components with two study arms. The first arm is comprised of participants enrolled in the TSSC Media Campaign(control group) and the second arm(intervention group)consisting of participants exposed to media campaign who will be exposed to additional outreach efforts by monthly visits from lay health workers.
Other Names:
  • TSSC Media Campaign Plus Refined Promotora Outreach group.(intervention group)
  • TSSC Media Campaign ONLY group. (Control group)
Control group
TSSC Media Campaign only participants who will receive a newsletter and the same exposure to the media campaign intervention as other community members not enrolled in the behavioral intervention.
Behavioral: Tu Salud Si Cuenta Behavioral Intervention
A behavioral intervention to assess the impact of the TSSC Media Campaign intervention outreach components with two study arms. The first arm is comprised of participants enrolled in the TSSC Media Campaign(control group) and the second arm(intervention group)consisting of participants exposed to media campaign who will be exposed to additional outreach efforts by monthly visits from lay health workers.
Other Names:
  • TSSC Media Campaign Plus Refined Promotora Outreach group.(intervention group)
  • TSSC Media Campaign ONLY group. (Control group)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168765

Locations
United States, Texas
University of Texas School of Public Health-Brownsville Regional Campus
Brownsville, Texas, United States, 78520
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Belinda Reininger, DrPH University of Texas Health Science Center at Houston School of Public Health-Brownsville Regional Campus
  More Information

No publications provided

Responsible Party: Belinda Reininger, Associate Professor, Health Promotion and Behavioral Sciences, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01168765     History of Changes
Other Study ID Numbers: HSC-SPH-10-0015, 2010-033710
Study First Received: July 21, 2010
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Physical Activity, Mexican-American, Obesity, Diabetes, Nutrition, Border Health

Additional relevant MeSH terms:
Obesity
Diabetes Mellitus
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014