M D Anderson Cancer Center
Houston, Texas, 77030, United States
NCT Number: NCT03199209
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receive information about healthy lifestyles
Attend study visit with research staff
Other names: Healthcare Visit, Patient Encounter, Subject Visit, visit
Ancillary studies
Receive information about healthy lifestyles
Other names: Text; SMS Text Message; SMS Text
Time frame: 12 months
Changes in physical activity determined by using univariable and multivariable mixed effect models.
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.
M.D. Anderson Cancer Center
Other
Tu Salud ¡Si Cuenta! (Your Health Matters!): Promoting Healthy Lifestyles in Latino Family Dyads
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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