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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source | |
| R56HL128705 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention (TSSC intervention) | Experimental | Participants undergo two TSSC intervention sessions delivered at participants' homes by trained CHWs over 1.5 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Dietary Intervention | Behavioral | Undergo TSSC intervention sessions |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
1) Pregnancy at any point during the study period OR considering pregnancy during the study period
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| Name | Affiliation | Role |
|---|---|---|
| Larkin Strong | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Behavioral Intervention | Behavioral | Undergo TSSC intervention sessions |
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