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

NCT06433258 | Recruiting

• 1 other identifier: HSC-SPH-23-1025
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Enhanced TSSC curriculum

EXPERIMENTAL

Behavioral: Enhanced TSSC curriculum

Original TSSC curriculum

ACTIVE COMPARATOR

Behavioral: Original TSSC curriculum

Interventions

Enhanced TSSC curriculum BEHAVIORAL

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.

Enhanced TSSC curriculum

Original TSSC curriculum BEHAVIORAL

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.

Original TSSC curriculum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• residents of partnering municipalities throughout Cameron and Hidalgo

You may not qualify if:

• participated in TSSC before

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Cancer Prevention Research Institute of Texas: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Belinda Reininger, DrPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Belinda Reininger, DrPH

CONTACT

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

Maria Zolezzi

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: May 3, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)