CClinicalTrials.gg
RecruitingNCT06433258Updated May 29, 2024

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

An interventional study of Enhanced TSSC curriculum and Original TSSC curriculum in Cancer Prevention, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started May 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer Prevention
03

In context

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • residents of partnering municipalities throughout Cameron and Hidalgo

Exclusion criteria

Exclusion Criteria:

  • participated in TSSC before
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    Enhanced TSSC curriculum

    Behavioral: Enhanced TSSC curriculum

  • Active comparator
    Original TSSC curriculum

    Behavioral: Original TSSC curriculum

Interventions

  • BehavioralEnhanced 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.

  • BehavioralOriginal 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06433258
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborators
Cancer Prevention Research Institute of Texas
Responsible party
Belinda Reininger (Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
May 29, 2024
Start date
May 3, 2024
Primary completion
Mar 1, 2025 (estimated)
Completion
Mar 1, 2025 (estimated)
Last update
May 29, 2024

Study contacts

Belinda Reininger, DrPH
Contact
Belinda.M.Reininger@uth.tmc.edu
(956) 755-0600
Maria Zolezzi
Contact
Maria.E.Zolezzi@uth.tmc.edu
(956) 755-0600
Belinda Reininger, DrPH
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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