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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Tu Salud ¡Si Cuenta! Reaching Latino Family Dyads to Increase Physical Activity and Healthy Eating

Conditions
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Healthy Subject

Intervention / Treatment
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* Behavioral: Behavioral Dietary Intervention
* Behavioral: Behavioral Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported Hispanic/Latino ethnicity Age 18-65 years 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: 1) Pregnancy at any point during the study period OR considering pregnancy during the study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention (TSSC intervention)<br>Participants undergo two TSSC intervention sessions delivered at participants' homes by trained CHWs over 1.5 hours. | Behavioral: Behavioral Dietary Intervention<br>* Undergo TSSC intervention sessions<br>Behavioral: Behavioral Intervention<br>* Undergo TSSC intervention sessions<br>* Other names: Behavioral Treatments;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of perceived determinants of healthy eating and physical activity (PA) as determined by questionnaires and interviews | 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. | Up to 2 years | 
| Evaluate and adapt the Tu Salud Si Cuenta (TSSC/Your Health Matters!) intervention | 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. | Up to 2 years | 
| Evaluate the acceptability of intervention content, materials, and procedures | 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. | Up to 2 years |