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

Healthy Subject Clinical Trial

Official title:

Tu Salud ¡Si Cuenta! Reaching Latino Family Dyads to Increase Physical Activity and Healthy Eating

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03199365
• Other study ID #: 2015-0735
• Secondary ID: NCI-2018-0113620
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 10, 2016
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVES:

I. Conduct formative research with adult Latino family dyads to assess the home environment and current behaviors, and identify perceived determinants of healthy eating and physical activity (PA) within the family context.

II. Adapt the "Tu Salud Si Cuenta" (TSSC) intervention to focus on increasing physical activity (PA) and healthy eating among adult Latino family dyads (TSSC-Family).

III. Evaluate the acceptability of intervention content, materials, and procedures with adult Latino family dyads.

OUTLINE:

FORMATIVE RESEARCH: To adapt the intervention, participants undergo immersive assessment over 3 hours which is conducted by research staff and involves examination of the home food and PA environments, objective and self-reported PA, nutritional intake, demographics and relevant psychosocial measures. Participants are also instructed to wear an accelerometer device to measure physical activity for up to 7 days and participate in in-depth interviews over 1.5 hours.

PRE-TESTING: Participants undergo two TSSC intervention sessions delivered at participants' homes by trained community health workers (CHWs) over 1.5 hours.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Self-reported Hispanic/Latino ethnicity

2. Age 18-65 years

3. Speak English or Spanish

4. Physically able to engage in low-to-moderate PA

5. Consumption of fewer than 5 servings of fruits and vegetables per day

6. Valid home address in the Houston neighborhoods of Gulfton, the East End/Magnolia, or Near Northside, or adjacent neighborhoods

7. Working telephone number

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Behavioral:
• Behavioral Dietary Intervention
Undergo TSSC intervention sessions
• Behavioral Intervention
Undergo TSSC intervention sessions

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   University of Texas MD Anderson Cancer Center Website