Seamos Saludables - Physical Activity Intervention Study for Latinas
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|ClinicalTrials.gov Identifier: NCT01583140|
Recruitment Status : Completed
First Posted : April 23, 2012
Last Update Posted : January 28, 2013
In this study the investigators are specifically targeting Latina women because they are more likely to be inactive and, therefore, are at higher risk for developing chronic conditions like obesity, diabetes, or cardiovascular disease. Through focus groups and cognitive interviews with Latinas in the Providence area, the investigators have modified our print-based intervention, already tested and proven to be effective in English-speaking communities, to be culturally and linguistically appropriate for the Latina community.
The objective of Seamos Saludables is to determine whether this culturally tailored print intervention will produce greater increases in physical activity levels among Latina women than a program focused on general health topics. Participants are randomly assigned to one of two groups (exercise and general wellness) and attend 4 clinic visits to complete baseline and follow-up assessments.
The investigators hypothesize that at the end of treatment, intervention participants will report significantly more minutes of at least moderate intensity physical activity per week than the wellness contact control participants.
|Condition or disease||Intervention/treatment||Phase|
|Sedentary Lifestyle||Behavioral: Wellness control Behavioral: Physical Activity Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||312 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Culturally and Linguistically Adapted Physical Activity Intervention for Latinas (Seamos Saludables)|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
Experimental: Exercise Intervention
Culturally-modified, individually tailored physical activity print materials
Behavioral: Physical Activity Intervention
Participants in the Physical Activity Intervention arm of the study receive culturally-modified, individually tailored physical activity print materials.
Active Comparator: Control
Bilingual health education booklets
Behavioral: Wellness control
Participants in the Wellness Control arm of the study receive a variety of print materials focused on general health topics.
- Change in total weekly minutes of physical activity as measured by the 7-Day PAR (Physical Activity Recall), from Baseline to 6-months and 12-months [ Time Frame: 6 and 12 months ]The 7-Day PAR is an interviewer administered instrument that uses multiple strategies for increasing accuracy of participant recall regarding many types of activities including time spent sleeping and in moderate, hard, and very hard activity. The 7-Day PAR is used across many studies in physical activity and has consistently demonstrated acceptable reliability, internal consistency, and congruent validity with other more objective measures of activity levels, along with sensitivity to changes in both moderate and intensive levels of physical activity.
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): NCT01583140
|United States, Rhode Island|
|Brown University Institute for Community Health Promotion|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Bess H Marcus, Ph.D.||University of California, San Diego|