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

May 22, 2024 updated by: Belinda Reininger, The University of Texas Health Science Center, Houston

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Baseline , 6 month follow up , 9 month month follow up
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
Time Frame: Baseline , 6 month follow up , 9 month month follow up
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
Time Frame: Baseline , 6 month follow up , 9 month month follow up
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
Time Frame: Baseline , 6 month follow up , 9 month month follow up
Baseline , 6 month follow up , 9 month month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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