Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06433258

Conditions

Cancer Prevention

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enhanced TSSC curriculum

Original TSSC curriculum

Study Details

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.

Conditions

Cancer Prevention

Study ID

NCT06433258

Start date

May 3, 2024

Status verified date

May, 2024

Completion date

Mar 1, 2025

Anticipated

Primary completion date

Mar 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • residents of partnering municipalities throughout Cameron and Hidalgo

Exclusion Criteria:

  • participated in TSSC before

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Enhanced TSSC curriculum

active comparator: Original TSSC curriculum

Interventions

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.

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Belinda Reininger, DrPH

(956) 755-0600Belinda.M.Reininger@uth.tmc.edu

Maria Zolezzi

(956) 755-0600Maria.E.Zolezzi@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Belinda Reininger, DrPH

956-755-0600Belinda.M.Reininger@uth.tmc.edu

Maria Zolezzi

(956) 755-0600Maria.E.Zolezzi@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 29, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2024-05-29.