Family MemberNCT03199209
Your Health Matters! (Tu Salud ¡Si Cuenta!): Promoting Healthy Lifestyles in Latino Families
A study testing Behavioral, Psychological or Informational Intervention, Patient Visit and Questionnaire Administration in people with Family Member and Health Status Unknown, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Family Member, Health Status Unknown
- What is being tested?
- Behavioral, Psychological or Informational Intervention, Patient Visit and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2016to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Family Member, Health Status Unknown
- Being tested
- Behavioral, Psychological or Informational Intervention, Patient Visit, Questionnaire Administration, Text Message
- Keywords
- physical activity, healthy eating, behavioral intervention, community health worker, Hispanic/Latino
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral, Psychological or Informational InterventionOther
Receive information about healthy lifestyles
Behavioral, Psychological or Informational InterventionOther
Receive information about healthy homes
Patient VisitBehavioural
Also called Healthcare Visit, Patient Encounter, Subject Visit, visit
Attend study visit with research staff
Questionnaire AdministrationOther
Ancillary studies
Text MessageOther
Also called Text; SMS Text Message; SMS Text
Receive information about healthy lifestyles
Text MessageOther
Also called Text; SMS Text Message; SMS Text
Receive texts about healthy homes
| Study group | Role | What they receive |
|---|---|---|
| Group I (home visit, information about healthy lifestyles) | Experimental | 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. Receives: Other: Behavioral, Psychological or Informational Intervention; Behavioral: Patient Visit; Other: Questionnaire Administration; Other: Text Message |
| Group II (home visit, information about healthy homes) | Experimental | 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. Receives: Other: Behavioral, Psychological or Informational Intervention; Behavioral: Patient Visit; Other: Questionnaire Administration; Other: Text Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Physical Activity
Changes in physical activity determined by using univariable and multivariable mixed effect models.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start6 Jun 2016
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family MemberStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Larkin Strong, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199209
- Sponsor's protocol ID
- 2016-0399
- Other IDs
- NCI-2019-02503, 2016-0399
- Status last verified
- Aug 2026
- First submitted
- 22 Jun 2017
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tu Salud ¡Si Cuenta! (Your Health Matters!): Promoting Healthy Lifestyles in Latino Family Dyads
- ClinicalTrials.gov ID
- NCT03199209
- Acronym / sponsor ID
- 2016-0399
- Conditions
- Family Member, Health Status Unknown
- Keywords
- physical activity, healthy eating, behavioral intervention, community health worker, Hispanic/Latino
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 6 Jun 2016 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (home visit, information about healthy lifestyles) | Experimental | Other: Behavioral, Psychological or Informational Intervention, Behavioral: Patient Visit, Other: Questionnaire Administration, Other: Text MessageParticipants 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 (home visit, information about healthy homes) | Experimental | Other: Behavioral, Psychological or Informational Intervention, Behavioral: Patient Visit, Other: Questionnaire Administration, Other: Text MessageParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral, Psychological or Informational InterventionReceive information about healthy lifestyles | Other | Group I (home visit, information about healthy lifestyles) |
| Behavioral, Psychological or Informational InterventionReceive information about healthy homes | Other | Group II (home visit, information about healthy homes) |
| Patient VisitAlso: Healthcare Visit, Patient Encounter, Subject Visit, visitAttend study visit with research staff | Behavioural | Group I (home visit, information about healthy lifestyles), Group II (home visit, information about healthy homes) |
| Questionnaire AdministrationAncillary studies | Other | Group I (home visit, information about healthy lifestyles), Group II (home visit, information about healthy homes) |
| Text MessageAlso: Text; SMS Text Message; SMS TextReceive information about healthy lifestyles | Other | Group I (home visit, information about healthy lifestyles) |
| Text MessageAlso: Text; SMS Text Message; SMS TextReceive texts about healthy homes | Other | Group II (home visit, information about healthy homes) |
Primary outcome
Changes in Physical Activity
Time frame: 12 months
Changes in physical activity determined by using univariable and multivariable mixed effect models.
Increase in Fruit and Vegetable (F/V) Consumption
Time frame: 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larkin Strong principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral, Psychological or Informational Intervention, Patient Visit and Questionnaire Administration in people with Family Member and Health Status Unknown, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Physical Activity (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.