Tu Salud Si Cuenta Intervention in Increasing Physical Activity and Healthy Eating Among Latino Families

NCT03199365 | Active Not Recruiting

• 4 other identifiers: 2015-0735NCI-2018-01136P30CA016672R56HL128705
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. Improving physical activity and healthy eating habits may help in preventing cancer-related diseases and lead to a better quality of life among Latino families.

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (3)

• Identification of perceived determinants of healthy eating and physical activity (PA) as determined by questionnaires and interviews

  The appropriate summary statistics will be calculated for continuous and categorical variables along with corresponding liberal (i.e., 80%) confidence intervals where appropriate. Boxplots, histograms, and other graphical displays will also be generated in order to describe the sample. Descriptive information will be used to inform future trials aimed at testing the intervention.

  Up to 2 years

• Evaluate and adapt the "Tu Salud Si Cuenta" (TSSC/Your Health Matters!) intervention

  Results from the formative research phase will inform the adaptation of the TSSC intervention to focus on dyadic collaboration and support. In general, TSSC-Family is proposed as a 6-month intervention involving six monthly home visits by a community health worker (CHW) who will deliver the TSSC curricula (Fitness for Life and Nutritious Eating), adapted for the dyadic approach, using non-directive motivational techniques. Participants will be instructed in standard behavioral skills such as self-monitoring, goal setting, problem solving, and relapse prevention.

  Up to 2 years

• Evaluate the acceptability of intervention content, materials, and procedures

  The appropriate summary statistics will be calculated for continuous and categorical variables along with corresponding liberal (i.e., 80%) confidence intervals where appropriate. Boxplots, histograms, and other graphical displays will also be generated in order to describe the sample. Descriptive information will be used to inform future trials aimed at testing the intervention.

  Up to 2 years

Study Arms (1)

Prevention (TSSC intervention)

EXPERIMENTAL

Participants undergo two TSSC intervention sessions delivered at participants' homes by trained CHWs over 1.5 hours.

Behavioral: Behavioral Dietary Intervention; Behavioral: Behavioral Intervention

Interventions

Behavioral Dietary Intervention BEHAVIORAL

Undergo TSSC intervention sessions

Prevention (TSSC intervention)

Behavioral Intervention BEHAVIORAL

Undergo TSSC intervention sessions

Also known as: Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, BEHAVIORAL THERAPY, Behavioral Treatment, Behavioral Treatments

Prevention (TSSC intervention)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported Hispanic/Latino ethnicity
• Age 18-65 years
• Speak English or Spanish
• Physically able to engage in low-to-moderate PA
• Consumption of fewer than 5 servings of fruits and vegetables per day
• Valid home address in the Houston neighborhoods of Gulfton, the East End/Magnolia, or Near Northside, or adjacent neighborhoods
• Working telephone number

You may not qualify if:

• \) Pregnancy at any point during the study period OR considering pregnancy during the study period

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Larkin Strong

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: June 26, 2017
• Study Start: June 10, 2016
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)