Seamos Activas: Increasing Physical Activity Among Latinas

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dr.Bess Marcus, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00724165
First received: July 25, 2008
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Inactivity
Behavioral: Intervention
Behavioral: Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Seamos Activas: Increasing Physical Activity Among Latinas

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Self-Reported physical activity [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: September 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: Intervention
Culturally-modified, individually tailored physical activity print materials
Active Comparator: 2 Behavioral: Control
Bilingual health education booklets

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724165

Locations
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Bess H Marcus, PhD Alpert Medical School of Brown University
  More Information

No publications provided by University of California, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr.Bess Marcus, Professor and Chair, Department of Family and Preventive Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00724165     History of Changes
Other Study ID Numbers: R21NR009864, R21NR009864
Study First Received: July 25, 2008
Last Updated: February 4, 2013
Health Authority: United States: Federal Government

Keywords provided by University of California, San Diego:
physical activity
Latinas

ClinicalTrials.gov processed this record on October 21, 2014