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

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ClinicalTrials.gov Identifier: NCT03199209
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : June 3, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Family Member Health Status Unknown Other: Behavioral, Psychological or Informational Intervention Behavioral: Patient Visit Other: Questionnaire Administration Other: Text Message Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Tu Salud ¡Si Cuenta! (Your Health Matters!): Promoting Healthy Lifestyles in Latino Family Dyads
Actual Study Start Date : June 6, 2016
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

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

Behavioral: Patient Visit
Attend study visit with research staff
Other Names:
  • Healthcare Visit
  • Patient Encounter
  • Subject Visit
  • visit

Other: Questionnaire Administration
Ancillary studies

Other: Text Message
Receive information about healthy lifestyles
Other Name: 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: 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: Questionnaire Administration
Ancillary studies

Other: Text Message
Receive texts about healthy homes
Other Name: Text; SMS Text Message; SMS Text




Primary Outcome Measures :
  1. Changes in Physical Activity [ Time Frame: 12 months ]
    Changes in physical activity determined by using univariable and multivariable mixed effect models.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199209


Contacts
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Contact: Larkin L. Strong 713-563-8930 llstrong@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Larkin Strong    713-563-8930      
Principal Investigator: Larkin Strong         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Larkin Strong M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03199209     History of Changes
Other Study ID Numbers: 2016-0399
NCI-2019-02503 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0399 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
R01HL128705 ( U.S. NIH Grant/Contract )
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
physical activity
healthy eating
behavioral intervention
community health worker
Hispanic/Latino