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Clinical Trials/NCT03199365
NCT03199365
Active, not recruiting
Not Applicable

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

M.D. Anderson Cancer Center1 site in 1 country80 target enrollmentJune 10, 2016

Overview

Phase
Not Applicable
Intervention
Behavioral Dietary Intervention
Conditions
Healthy Subject
Sponsor
M.D. Anderson Cancer Center
Enrollment
80
Locations
1
Primary Endpoint
Identification of perceived determinants of healthy eating and physical activity (PA) as determined by questionnaires and interviews
Status
Active, not recruiting
Last Updated
16 days ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 10, 2016
End Date
April 30, 2027
Last Updated
16 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Prevention (TSSC intervention)

Participants undergo two TSSC intervention sessions delivered at participants' homes by trained CHWs over 1.5 hours.

Intervention: Behavioral Dietary Intervention

Prevention (TSSC intervention)

Participants undergo two TSSC intervention sessions delivered at participants' homes by trained CHWs over 1.5 hours.

Intervention: Behavioral Intervention

Outcomes

Primary Outcomes

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.

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.

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.

Study Sites (1)

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