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Implementation and Evaluation of an Evidence-Based, Multilevel Lifestyle Intervention for Underserved and Rural Populations in South Texas

Implementation and Evaluation of an Evidence-Based, Multilevel Lifestyle Intervention for Underserved and Rural Populations in South Texas: Tu Salud ¡Si Cuenta (TSSC)!

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06433258
Enrollment
500
Registered
2024-05-29
Start date
2024-05-03
Completion date
2025-03-01
Last updated
2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Prevention

Brief summary

The purpose of this study is to enhance the current TSSC multilevel intervention delivered in Cameron and Hidalgo counties by adding additional components including an educational module on the risks of alcohol intake and its connection to cancer, as well as developing training and referral systems to address social determinants of health (SDOH) that negatively impact uptake of cancer prevention behaviors.

Interventions

BEHAVIORALEnhanced TSSC curriculum

In addition to the original TSSC curriculum participants will also be educated with the enhanced curriculum which includes components related to alcohol and social determinants of health needs) to promote cancer prevention through healthy lifestyles.

BEHAVIORALOriginal TSSC curriculum

Participants will be educated with evidence-based modules focused on topics such as introduction to TSSC, physical activity, fruit and vegetable consumption, reduce sugar intake, diabetes, portion control, cancer, and high blood pressure.These modules are provided by community health workers who have been trained in the contents of the modules, as well as motivational interviewing techniques for delivering the modules.

Sponsors

Cancer Prevention Research Institute of Texas
CollaboratorOTHER
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* residents of partnering municipalities throughout Cameron and Hidalgo

Exclusion criteria

* participated in TSSC before

Design outcomes

Primary

MeasureTime frame
Change in percentage of participants that report a reduced frequency of alcohol intake as assessed by a questionnaireBaseline , 6 month follow up , 9 month month follow up
Change in percentage of participants that show an increase in moderate and vigorous physical activity minutes as assessed by the Physical Activity QuestionnaireBaseline , 6 month follow up , 9 month month follow up
Change in percentage of participants that report increase in fruit and vegetable intake as assessed by the Nutritious Eating QuestionnaireBaseline , 6 month follow up , 9 month month follow up
Change in percentage of participants that report a reduced quantity of alcohol intake as assessed by a questionnaireBaseline , 6 month follow up , 9 month month follow up

Countries

United States

Contacts

Primary ContactBelinda Reininger, DrPH
Belinda.M.Reininger@uth.tmc.edu(956) 755-0600
Backup ContactMaria Zolezzi
Maria.E.Zolezzi@uth.tmc.edu(956) 755-0600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026