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

Cancer Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06433258
• Other study ID #: HSC-SPH-23-1025
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Belinda Reininger, DrPH
• Phone: (956) 755-0600
• Email: Belinda.M.Reininger[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• residents of partnering municipalities throughout Cameron and Hidalgo

Exclusion Criteria:

• participated in TSSC before

Related Conditions & MeSH terms

• Cancer Prevention

Intervention

Behavioral:
• Enhanced 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.
• Original 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Cancer Prevention Research Institute of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in percentage of participants that show an increase in moderate and vigorous physical activity minutes as assessed by the Physical Activity Questionnaire		Baseline , 6 month follow up , 9 month month follow up
Primary	Change in percentage of participants that report increase in fruit and vegetable intake as assessed by the Nutritious Eating Questionnaire		Baseline , 6 month follow up , 9 month month follow up
Primary	Change in percentage of participants that report a reduced quantity of alcohol intake as assessed by a questionnaire		Baseline , 6 month follow up , 9 month month follow up
Primary	Change in percentage of participants that report a reduced frequency of alcohol intake as assessed by a questionnaire		Baseline , 6 month follow up , 9 month month follow up