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Trial Title:
Implementation and Evaluation of an Evidence-Based, Multilevel Lifestyle Intervention for Underserved and Rural Populations in South Texas
NCT ID:
NCT06433258
Condition:
Cancer Prevention
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
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.
Arm group label:
Enhanced TSSC curriculum
Intervention type:
Behavioral
Intervention name:
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.
Arm group label:
Original TSSC curriculum
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- residents of partnering municipalities throughout Cameron and Hidalgo
Exclusion Criteria:
- participated in TSSC before
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Texas Health Science Center at Houston
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Belinda Reininger, DrPH
Phone:
956-755-0600
Email:
Belinda.M.Reininger@uth.tmc.edu
Contact backup:
Last name:
Maria Zolezzi
Phone:
(956) 755-0600
Email:
Maria.E.Zolezzi@uth.tmc.edu
Start date:
May 3, 2024
Completion date:
March 1, 2025
Lead sponsor:
Agency:
The University of Texas Health Science Center, Houston
Agency class:
Other
Collaborator:
Agency:
Cancer Prevention Research Institute of Texas
Agency class:
Other
Source:
The University of Texas Health Science Center, Houston
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06433258
