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

NCT ID: NCT06433258

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-03

Study Completion Date

2025-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Enhanced TSSC curriculum

Group Type EXPERIMENTAL

Enhanced TSSC curriculum

Intervention Type 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.

Original TSSC curriculum

Group Type ACTIVE_COMPARATOR

Original TSSC curriculum

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* residents of partnering municipalities throughout Cameron and Hidalgo

Exclusion Criteria

* participated in TSSC before
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Prevention Research Institute of Texas

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Belinda Reininger

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Belinda Reininger, DrPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Belinda Reininger, DrPH

Role: CONTACT

(956) 755-0600

Maria Zolezzi

Role: CONTACT

(956) 755-0600

Facility Contacts

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Belinda Reininger, DrPH

Role: primary

956-755-0600

Maria Zolezzi

Role: backup

(956) 755-0600

Other Identifiers

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HSC-SPH-23-1025

Identifier Type: -

Identifier Source: org_study_id

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