Your Health Matters! (Tu Salud ¡Si Cuenta!): Promoting Healthy Lifestyles in Latino Families

Health Status Unknown Clinical Trial

Official title:

Tu Salud ¡Si Cuenta! (Your Health Matters!): Promoting Healthy Lifestyles in Latino Family Dyads

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03199209
• Other study ID #: 2016-0399
• Secondary ID: NCI-2019-0250320
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 6, 2016
• Est. completion date: December 31, 2025

Study information

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

Clinical Trial Summary

This trial studies how well a theoretically-based motivational behavior change program called Tu Salud Si Cuenta! works in promoting healthy lifestyles in Latino families. Tu Salud Si Cuenta! will deliver programs on healthy lifestyles and healthy homes to Hispanic/Latino families and may help to improve their health.

Description:

PRIMARY OBJECTIVES: I. To evaluate the efficacy of the Tu Salud, Si Cuenta! Familiar (TSSC-Family) intervention in facilitating positive changes in physical activity and nutrition among Latino adults not meeting physical activity or nutrition recommendations. SECONDARY OBJECTIVES: I. To test the effects of TSSC-Family on hypothesized intervention mechanisms (e.g., self-efficacy, stage of change, social support, social control), and the role of those mechanisms in mediating TSSC-Family effects of physical activity and nutrition outcomes. OUTLINE: Participants are randomized to 1 of 2 groups. GROUP I: Participants and their family member meet with a community health worker in their home over 90 minutes to learn about physical activity, healthy eating, and to set goals, once a month for 6 months. Participants also receive 2-5 text messages per week that contain health tips related to healthy lifestyles and information about local resources. Participants also attend a study visit with a research staff over 90-120 minutes at a community center, MD Anderson, or at home at baseline, 6 months, and 12 months. GROUP II: Participants and their family member meet with a community health worker in their home over 90 minutes to receive information on how to be safe and healthy at home and information about indoor air quality, home safety, cardiopulmonary resuscitation (CPR)/first aid, how to prepare for emergencies, and keeping pests away, once a month for 6 months. Participants also receive 2-5 text messages per week that contain information about healthy homes and local resources. Participants also attend a study visit with a research staff over 90-120 minutes at a community center, MD Anderson, or at home at baseline, 6 months, and 12 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Self-reported Hispanic/Latino ethnicity.
• Speak English or Spanish.
• Physically able to engage in low-to-moderate physical activity (PA) as assessed by the PA Readiness Questionnaire (PAR-Q), or with medical clearance.
• Insufficient self-reported moderate-to-vigorous PA (< 150 minutes/week) or limited fruits and vegetable (FV) intake (defined as less than or equal to 4 cups of FV combined or < 1 cup of vegetables per day).
• Able to enroll with one eligible adult family member.
• Valid home address in the Houston neighborhoods of Gulfton, the East End/Magnolia, Northside, Pasadena or adjacent neighborhoods.
• Have a functioning cellular telephone and able and willing to send and receive text messages.
• Blood pressure reading less than 160/100 mmHg, or with medical clearance.

Exclusion Criteria:

• Pregnancy or considering pregnancy during the study period, self-reported.
• Currently participating in a program or research study to promote physical activity, healthy eating, or weight loss.
• Plans to move outside the greater Houston area during the study period.
• Past weight loss surgery.

Related Conditions & MeSH terms

• Family Member
• Health Status Unknown

Intervention

Other:
• Behavioral, Psychological or Informational Intervention
Receive information about healthy lifestyles
• Behavioral, Psychological or Informational Intervention
Receive information about healthy homes

Behavioral:
• Patient Visit
Attend study visit with research staff

Other:
• Questionnaire Administration
Ancillary studies
• Text Message
Receive information about healthy lifestyles
• Text Message
Receive texts about healthy homes

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	Changes in Physical Activity	Changes in physical activity determined by using univariable and multivariable mixed effect models.	12 months
Primary	Increase in Fruit and Vegetable (F/V) Consumption	Assuming 1.6 portions of F/V consumed per day in the control group, power calculations show that Poisson regression model with a 0.05 two-sided significance level has 80% power to detect a 22% or greater increase (rate ratio (RR) =1.22) in portions of F/V consumption for intervention group if we have total 522 participants (261 dyads) with Intra-cluster correlation coefficient (ICC) of 0.08.	12 months

External Links

•   University of Texas MD Anderson Cancer Center Website