- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00724165
Seamos Activas: Increasing Physical Activity Among Latinas
February 4, 2013 updated by: Dr.Bess Marcus, University of California, San Diego
The overarching goal of this project is to develop a culturally congruent intervention to increase levels of physical activity among sedentary Latinas (i.e., Latina/Hispanic women).
The first phase will involve culturally and linguistically modifying an existing evidenced-based intervention, founded on the Transtheoretical Model and Social Cognitive Theory, to target sedentary Latinas.
Then, we will conduct a pilot randomized clinical trial to test whether the culturally-modified individually tailored intervention increases physical activity levels in comparison to standard care comprised of bilingual health education booklets.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
While the general United States population is suffering from an epidemic of sedentary lifestyle, Latinos are even more sedentary than their non-Hispanic white counterparts.
Notably, Latinos suffer from greater rates of morbidity and mortality of conditions associated with being sedentary than non-Hispanic whites.
One concern is that due to cultural artifacts, socioeconomic circumstances, and language barriers, Latinos have limited access to public health interventions that promote active lifestyles.
The current study will advance nursing science by using a theory-based computer-run expert system to provide an effective physical activity intervention for this underserved population.
The consent form was completed by all participants and describes the nature and purpose of the study, procedure, risks and benefits to participating, alternative therapies available, and confidentiality.
Study Type
Interventional
Enrollment (Actual)
106
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02912
- Brown University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Sedentary (i.e., participating in moderate or vigorous physical activity two days per week or less for 30 minutes or less each day) women ages 18 to 65 who self-identify as Latina (or of a group defined as Hispanic/Latino by the Census Bureau) are eligible for participation
Exclusion Criteria:
- Exclusion criteria are history of coronary heart disease (history of myocardial infarction or symptoms of angina), diabetes, stroke, osteoarthritis, osteoporosis, orthopedic problems, or any other serious medical condition that would make physical activity unsafe. Other exclusion criteria will include individuals who report consuming three or more alcoholic drinks per day, current or planned pregnancy, planning to move from the area within the next six months, current suicidal ideation or psychosis, current clinical depression, hospitalization due to a psychiatric disorder in the past 3 years, BMI above 40, and/or taking medication that may impair physical activity tolerance or performance (e.g., beta blockers). Participants in the pilot study must also agree to be assigned to one of the two intervention conditions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
|
Culturally-modified, individually tailored physical activity print materials
|
|
Active Comparator: 2
|
Bilingual health education booklets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Self-Reported physical activity
Time Frame: Baseline, 3 months, and 6 months
|
Baseline, 3 months, and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Bess H Marcus, PhD, Alpert Medical School of Brown University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
July 25, 2008
First Submitted That Met QC Criteria
July 25, 2008
First Posted (Estimate)
July 29, 2008
Study Record Updates
Last Update Posted (Estimate)
February 6, 2013
Last Update Submitted That Met QC Criteria
February 4, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R21NR009864 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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