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)!

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Prevention
• Intervention / Treatment: Behavioral: Enhanced TSSC curriculum; Behavioral: Original TSSC curriculum

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Belinda Reininger, DrPH; Phone Number: (956) 755-0600; Email: Belinda.M.Reininger@uth.tmc.edu
• Study Contact Backup: Name: Maria Zolezzi; Phone Number: (956) 755-0600; Email: Maria.E.Zolezzi@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Maria Zolezzi; Phone Number: (956) 755-0600; Email: Maria.E.Zolezzi@uth.tmc.edu
      • Contact: Belinda Reininger, DrPH; Phone Number: 956-755-0600; Email: Belinda.M.Reininger@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• residents of partnering municipalities throughout Cameron and Hidalgo

Exclusion Criteria:

• participated in TSSC before

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced TSSC curriculum	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.
Active Comparator: Original TSSC curriculum	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Cancer Prevention Research Institute of Texas
• Investigators: Principal Investigator: Belinda Reininger, DrPH, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HSC-SPH-23-1025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No