## Protocol Section
### Identification Module
**NCT ID:** NCT06433258

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

**Official Title:** Implementation and Evaluation of an Evidence-Based, Multilevel Lifestyle Intervention for Underserved and Rural Populations in South Texas: Tu Salud ¡Si Cuenta (TSSC)!

#### Organization Study ID Info
**ID:** HSC-SPH-23-1025
#### Organization
**Class:** OTHER
**Full Name:** The University of Texas Health Science Center, Houston
### Status Module
#### Completion Date
**Date:** 2025-03-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-03-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-03

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Cancer Prevention Research Institute of Texas

#### Lead Sponsor

**Class:** OTHER

**Name:** The University of Texas Health Science Center, Houston

#### Responsible Party

**Investigator Affiliation:** The University of Texas Health Science Center, Houston

**Investigator Full Name:** Belinda Reininger

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Cancer Prevention

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 500

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Enhanced TSSC curriculum

**Label:** Enhanced TSSC curriculum

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Behavioral: Original TSSC curriculum

**Label:** Original TSSC curriculum

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Enhanced TSSC curriculum

**Description:** 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.

**Name:** Enhanced TSSC curriculum

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Original TSSC curriculum

**Description:** 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.

**Name:** Original TSSC curriculum

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**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

**Measure:** 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

**Measure:** 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

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* residents of partnering municipalities throughout Cameron and Hidalgo

Exclusion Criteria:

* participated in TSSC before

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Belinda.M.Reininger@uth.tmc.edu

**Name:** Belinda Reininger, DrPH

**Phone:** (956) 755-0600

**Role:** CONTACT

**Contact 2:**

**Email:** Maria.E.Zolezzi@uth.tmc.edu

**Name:** Maria Zolezzi

**Phone:** (956) 755-0600

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Houston

**Contacts:**

***Contact 1:***

- **Email:** Belinda.M.Reininger@uth.tmc.edu

- **Name:** Belinda Reininger, DrPH

- **Phone:** 956-755-0600

- **Role:** CONTACT

***Contact 2:***

- **Email:** Maria.E.Zolezzi@uth.tmc.edu

- **Name:** Maria Zolezzi

- **Phone:** (956) 755-0600

- **Role:** CONTACT

**Country:** United States

**Facility:** The University of Texas Health Science Center at Houston

**State:** Texas

**Status:** RECRUITING

**Zip:** 77030

#### Overall Officials

**Official 1:**

**Affiliation:** The University of Texas Health Science Center, Houston

**Name:** Belinda Reininger, DrPH

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M3777

- Name: Ethanol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
