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

NCT ID: NCT03199209

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-06

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Family Member Health Status Unknown

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Behavioral, Psychological or Informational Intervention

Intervention Type OTHER

Receive information about healthy lifestyles

Patient Visit

Intervention Type BEHAVIORAL

Attend study visit with research staff

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Text Message

Intervention Type OTHER

Receive information about healthy lifestyles

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.

Group Type EXPERIMENTAL

Behavioral, Psychological or Informational Intervention

Intervention Type OTHER

Receive information about healthy homes

Patient Visit

Intervention Type BEHAVIORAL

Attend study visit with research staff

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Text Message

Intervention Type OTHER

Receive texts about healthy homes

Interventions

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Behavioral, Psychological or Informational Intervention

Receive information about healthy lifestyles

Intervention Type OTHER

Behavioral, Psychological or Informational Intervention

Receive information about healthy homes

Intervention Type OTHER

Patient Visit

Attend study visit with research staff

Intervention Type BEHAVIORAL

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Text Message

Receive information about healthy lifestyles

Intervention Type OTHER

Text Message

Receive texts about healthy homes

Intervention Type OTHER

Other Intervention Names

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Healthcare Visit Patient Encounter Subject Visit visit Text; SMS Text Message; SMS Text Text; SMS Text Message; SMS Text

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Larkin Strong

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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NCI-2019-02503

Identifier Type: REGISTRY

Identifier Source: secondary_id

2016-0399

Identifier Type: OTHER

Identifier Source: secondary_id

2016-0399

Identifier Type: -

Identifier Source: org_study_id

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