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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Family Member; Health Status Unknown
• Intervention / Treatment: Other: Questionnaire Administration; Other: Behavioral, Psychological or Informational Intervention; Other: Behavioral, Psychological or Informational Intervention; Behavioral: Patient Visit; Other: Text Message; Other: Text Message

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (home visit, information about healthy lifestyles); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Behavioral, Psychological or Informational Intervention; Receive information about healthy lifestyles; Other: Behavioral, Psychological or Informational Intervention; Receive information about healthy homes; Behavioral: Patient Visit; Attend study visit with research staff; Other Names: Healthcare Visit; Patient Encounter; Subject Visit; visit; Other: Text Message; Receive information about healthy lifestyles; Other Names: Text; SMS Text Message; SMS Text; Other: Text Message; Receive texts about healthy homes; Other Names: Text; SMS Text Message; SMS Text
Experimental: Group II (home visit, information about healthy homes); 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, 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.	Other: Questionnaire Administration; Ancillary studies; Other: Behavioral, Psychological or Informational Intervention; Receive information about healthy lifestyles; Other: Behavioral, Psychological or Informational Intervention; Receive information about healthy homes; Behavioral: Patient Visit; Attend study visit with research staff; Other Names: Healthcare Visit; Patient Encounter; Subject Visit; visit; Other: Text Message; Receive information about healthy lifestyles; Other Names: Text; SMS Text Message; SMS Text; Other: Text Message; Receive texts about healthy homes; Other Names: Text; SMS Text Message; SMS Text

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Physical Activity	Changes in physical activity determined by using univariable and multivariable mixed effect models.	12 months
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Larkin Strong, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2016
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 26, 2017

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; behavioral intervention; community health worker; healthy eating; Hispanic/Latino
• Other Study ID Numbers: 2016-0399 (Other Identifier: M D Anderson Cancer Center); NCI-2019-02503 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No