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Tu Salud Si Cuenta Intervention in Increasing Physical Activity and Healthy Eating Among Latino Families

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03199365
Recruitment Status : Active, not recruiting
First Posted : June 26, 2017
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This trial studies how a program to encourage healthy behaviors (Tu Salud Si Cuenta) works to increase physical activity and healthy eating habits among Latino families. Improving physical activity and healthy eating habits may help in preventing cancer-related diseases and lead to a better quality of life among Latino families.

Condition or disease Intervention/treatment Phase
Healthy Subject Behavioral: Behavioral Dietary Intervention Behavioral: Behavioral Intervention Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Conduct formative research with adult Latino family dyads to assess the home environment and current behaviors, and identify perceived determinants of healthy eating and physical activity (PA) within the family context.

II. Adapt the "Tu Salud Si Cuenta" (TSSC) intervention to focus on increasing physical activity (PA) and healthy eating among adult Latino family dyads (TSSC-Family).

III. Evaluate the acceptability of intervention content, materials, and procedures with adult Latino family dyads.

OUTLINE:

FORMATIVE RESEARCH: To adapt the intervention, participants undergo immersive assessment over 3 hours which is conducted by research staff and involves examination of the home food and PA environments, objective and self-reported PA, nutritional intake, demographics and relevant psychosocial measures. Participants are also instructed to wear an accelerometer device to measure physical activity for up to 7 days and participate in in-depth interviews over 1.5 hours.

PRE-TESTING: Participants undergo two TSSC intervention sessions delivered at participants' homes by trained community health workers (CHWs) over 1.5 hours.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Tu Salud ¡Si Cuenta! Reaching Latino Family Dyads to Increase Physical Activity and Healthy Eating
Actual Study Start Date : June 10, 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: Prevention (TSSC intervention)
Participants undergo two TSSC intervention sessions delivered at participants' homes by trained CHWs over 1.5 hours.
Behavioral: Behavioral Dietary Intervention
Undergo TSSC intervention sessions

Behavioral: Behavioral Intervention
Undergo TSSC intervention sessions
Other Names:
  • Behavior Conditioning Therapy
  • behavior modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • BEHAVIORAL THERAPY
  • Behavioral Treatment
  • Behavioral Treatments




Primary Outcome Measures :
  1. Identification of perceived determinants of healthy eating and physical activity (PA) as determined by questionnaires and interviews [ Time Frame: Up to 2 years ]
    The appropriate summary statistics will be calculated for continuous and categorical variables along with corresponding liberal (i.e., 80%) confidence intervals where appropriate. Boxplots, histograms, and other graphical displays will also be generated in order to describe the sample. Descriptive information will be used to inform future trials aimed at testing the intervention.

  2. Evaluate and adapt the "Tu Salud Si Cuenta" (TSSC/Your Health Matters!) intervention [ Time Frame: Up to 2 years ]
    Results from the formative research phase will inform the adaptation of the TSSC intervention to focus on dyadic collaboration and support. In general, TSSC-Family is proposed as a 6-month intervention involving six monthly home visits by a community health worker (CHW) who will deliver the TSSC curricula (Fitness for Life and Nutritious Eating), adapted for the dyadic approach, using non-directive motivational techniques. Participants will be instructed in standard behavioral skills such as self-monitoring, goal setting, problem solving, and relapse prevention.

  3. Evaluate the acceptability of intervention content, materials, and procedures [ Time Frame: Up to 2 years ]
    The appropriate summary statistics will be calculated for continuous and categorical variables along with corresponding liberal (i.e., 80%) confidence intervals where appropriate. Boxplots, histograms, and other graphical displays will also be generated in order to describe the sample. Descriptive information will be used to inform future trials aimed at testing the intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 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 PA
  • Consumption of fewer than 5 servings of fruits and vegetables per day
  • Valid home address in the Houston neighborhoods of Gulfton, the East End/Magnolia, or near Northside, or adjacent neighborhoods
  • Working telephone number

Exclusion Criteria:

  • Pregnancy at any point during the study period OR considering pregnancy during the study period

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): NCT03199365


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
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: NCT03199365     History of Changes
Other Study ID Numbers: 2015-0735
NCI-2018-01136 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2015-0735 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
R56HL128705 ( U.S. NIH Grant/Contract )
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: May 22, 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