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Healthy Lifestyle Program for Well-Being in Latino Families

N/A
Waitlist Available
Led By Larkin Strong
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-65 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial studies how a program to encourage healthy behaviors (Tu Salud Si Cuenta) works to increase physical activity and healthy eating habits among Latino families.

Who is the study for?
The trial is for Latino families with adults aged 18-65 who speak English or Spanish, live in specific Houston neighborhoods, and are physically able to do some exercise. They should eat less than 5 servings of fruits and veggies daily. Pregnant individuals or those considering pregnancy during the study can't participate.
What is being tested?
The 'Tu Salud Si Cuenta' program is being tested to see if it helps increase physical activity and encourages eating more fruits and vegetables among Latino families, potentially preventing cancer-related diseases.
What are the potential side effects?
Since this trial involves behavioral interventions like diet changes and increased physical activity, side effects may include muscle soreness from new exercises or digestive changes due to diet alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate and adapt the "Tu Salud Si Cuenta" (TSSC/Your Health Matters!) intervention
Evaluate the acceptability of intervention content, materials, and procedures
Identification of perceived determinants of healthy eating and physical activity (PA) as determined by questionnaires and interviews

Side effects data

From 2013 Phase 1 & 2 trial • 16 Patients • NCT01923896
13%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Behavioral Intervention & DCS
Behavioral Intervention & Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (TSSC intervention)Experimental Treatment2 Interventions
Participants undergo two TSSC intervention sessions delivered at participants' homes by trained CHWs over 1.5 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Dietary Intervention
2016
Completed Phase 1
~130
Behavioral Intervention
2021
Completed Phase 4
~3740

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,938 Previous Clinical Trials
47,792,218 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,728 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,090 Total Patients Enrolled
Larkin StrongPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
1,160 Total Patients Enrolled
~3 spots leftby Apr 2025
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