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Tu Salud Si Cuenta Media Campaign (TSSC)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Belinda Reininger, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00788879
First received: November 10, 2008
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

The Tu Salud, Si Cuenta (TSSC) media campaign uses behavioral journalism, community outreach and environmental changes to promote physical activity and nutritional changes among disadvantaged Mexican-Americans living along the U.S./Mexico border. This intervention posits that increased physical activity and increased fruit and vegetable consumption with smaller portion sizes will result in a decrease in obesity prevalence and diabetes incidence in this population.


Condition Intervention
Obesity
Diabetes
Behavioral: TSSC
Behavioral: TSSC Randomized Behavioral Intervention for weight loss

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of a Media Campaign: Tu Salud Si Cuenta

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Physical Activity [ Time Frame: baseline, yr. 3, post-intervention ] [ Designated as safety issue: No ]
  • Fruit and Vegetable Intake [ Time Frame: baseline, yr. 3, post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Waist circumference [ Time Frame: baseline, yr. 3, post-intervention ] [ Designated as safety issue: No ]
  • Hip circumference [ Time Frame: baseline, yr. 3, post-intervention ] [ Designated as safety issue: No ]
  • Confirmed Awareness: Confirmation of recognition of messages [ Time Frame: baseline, third year, post-intervention ] [ Designated as safety issue: No ]

Enrollment: 3100
Study Start Date: February 2003
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
This study arm is located in Brownsville, Texas. This community is exposed to the TSSC media messages as well as may be visited by the lay health workers and see the built environment changes
Behavioral: TSSC
The intervention community is exposed to the media messages of the TSSC campaign. Residents of this community also receive the lay health worker visits as well as benefit from the positive built environment changes.
Behavioral: TSSC Randomized Behavioral Intervention for weight loss

We will enroll up to 200 weight-loss challenge participants to receive text messages on personal mobile phones throughout the challenge. Consent and enrollment in the trial will take place at registration for the weight-loss community challenge in the language of their choice. Recruited participants will be randomly assigned to a group after consenting to the study and the timing and content of text messages will vary according to group assignment (Groups A - D).

Group A will receive weekly reminders for upcoming weigh-in events. Group B will receive the same weekly reminders but will also receive one-way messages every two weeks providing the participant motivational messages/topics and weight loss health tips. Group C will receive the same text messages as Group B but will also receive weekly prompts to self-monitor weight status. Group D will receive the same text messages as Group C plus daily prompts that will act as a guide for the participant to monitor behavior changes.

No Intervention: 2
The control group is located in Laredo. This community is not exposed to the TSSC messages nor does the campaign work to actively change the built environment or use lay health workers to share physical activity and nutrition information.

  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:

  • To be included in the evaluation survey study the participants must be living in Cameron park or Laredo TX at the time of the study, Hispanic men or women aged 20 - 75. The participants must speak Spanish.
  • To be included in the observational study of physical activity the participants must be visiting the observational study site (park, exercise facility, walking trail) at the time of observation. No other criteria for inclusion exists for this study.
  • To be included in the Randomized Behavioral Intervention, the participants must be participants in the weight-loss challenge and 18 years or older.

Exclusion Criteria:

  • Participants who will be excluded from the evaluation survey study include those who are not Hispanic, not living in Cameron Park or Laredo TX, unable to speak Spanish and are either older than 55 or younger than 20.
  • Participants excluded from the Randomized Behavioral Intervention are those younger than 18 and not participants of the weight loss challenge.
  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: NCT00788879

Locations
United States, Texas
University of Texas Houston Health Science Center, Brownsville Regional Campus
Brownsville, Texas, United States, 78521
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Belinda M Reininger, DrPH University of Texas Houston Health Science Center
Principal Investigator: Kevin Hwang, MD University of Texas Medical School
  More Information

Publications:
Responsible Party: Belinda Reininger, Associate Professor, Health Promotion and Behavioral Sciences, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00788879     History of Changes
Other Study ID Numbers: HSC-SPH-05-0488, NIH NCMHD P20 MD000170-06
Study First Received: November 10, 2008
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014