[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06433258":3,"trial-entities:NCT06433258":89,"trial-summary:NCT06433258":92},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":38,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":57,"locations":60,"central_contacts":81,"overall_officials":84,"references":87,"see_also_links":88},"NCT06433258","HSC-SPH-23-1025","Implementation and Evaluation of an Evidence-Based, Multilevel Lifestyle Intervention for Underserved and Rural Populations in South Texas","Implementation and Evaluation of an Evidence-Based, Multilevel Lifestyle Intervention for Underserved and Rural Populations in South Texas: Tu Salud ¡Si Cuenta (TSSC)!","UNKNOWN","2025-03-01","2024-05","2024-05-29","2024-05-03","The University of Texas Health Science Center, Houston","OTHER",false,"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.",null,[19],"Cancer Prevention",[],"INTERVENTIONAL","PREVENTION",[24],"NA",{"count":26,"type":27},500,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","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.",[31],{"type":30,"name":35,"description":36,"armGroupLabels":37},"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.",[35],[39,42,44,46],{"measure":40,"timeFrame":41},"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",{"measure":43,"timeFrame":41},"Change in percentage of participants that report increase in fruit and vegetable intake as assessed by the Nutritious Eating Questionnaire",{"measure":45,"timeFrame":41},"Change in percentage of participants that report a reduced quantity of alcohol intake as assessed by a questionnaire",{"measure":47,"timeFrame":41},"Change in percentage of participants that report a reduced frequency of alcohol intake as assessed by a questionnaire",[],"ALL","18 Years",{"inclusion":52,"exclusion":54,"raw_text":56},[53],"residents of partnering municipalities throughout Cameron and Hidalgo",[55],"participated in TSSC before","Inclusion Criteria:\n\n* residents of partnering municipalities throughout Cameron and Hidalgo\n\nExclusion Criteria:\n\n* participated in TSSC before",[58,59],"ADULT","OLDER_ADULT",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":78},"The University of Texas Health Science Center at Houston","RECRUITING","Houston","Texas","77030","United States",[69,74],{"name":70,"role":71,"phone":72,"email":73},"Belinda Reininger, DrPH","CONTACT","956-755-0600","Belinda.M.Reininger@uth.tmc.edu",{"name":75,"role":71,"phone":76,"email":77},"Maria Zolezzi","(956) 755-0600","Maria.E.Zolezzi@uth.tmc.edu",{"lat":79,"lon":80},29.76328,-95.36327,[82,83],{"name":70,"role":71,"phone":76,"email":73},{"name":75,"role":71,"phone":76,"email":77},[85],{"name":70,"affiliation":13,"role":86},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":90,"biomarkers":91},[19],[],{"nct_id":4,"found":93,"summary":94,"prompt_version":17},true,{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an interventional study with a planned enrollment of 500 participants. It is evaluating two behavioral interventions: the Original TSSC curriculum and an Enhanced TSSC curriculum.","completed","Lifestyle Intervention for Cancer Prevention in South Texas","This study is testing an enhanced lifestyle program called TSSC to help prevent cancer in underserved and rural communities in South Texas. The program offers education on healthy living, including physical activity, healthy eating, and reducing sugar intake. The enhanced version also includes information on alcohol risks and resources for social needs that affect health. Researchers want to see if participants increase their physical activity, eat more fruits and vegetables, and reduce alcohol intake over nine months. You can join if you are 18 or older and live in partnering municipalities in Cameron and Hidalgo counties, and have not participated in TSSC before. The study plans to enroll 500 people.","Participants will be followed for 9 months after the start of the study, with assessments at 6 and 9 months.",110,"Participants will receive education through either the Original TSSC curriculum or the Enhanced TSSC curriculum. Your physical activity, fruit and vegetable intake, and alcohol intake will be assessed at the start, and again at 6 and 9 months.","Not stated in the trial record.",[]]