Seamos Activas: Increasing Physical Activity Among Latinas

Inactivity Clinical Trial

Official title:

Seamos Activas: Increasing Physical Activity Among Latinas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724165
• Other study ID #: R21NR009864
• Secondary ID: R21NR009864
• Status: Completed
• Phase: Phase 2
• First received: July 25, 2008
• Last updated: February 4, 2013
• Start date: September 2006
• Est. completion date: July 2009

Study information

• Verified date: February 2013
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Inactivity

Intervention

Behavioral:
• Intervention
Culturally-modified, individually tailored physical activity print materials
• Control
Bilingual health education booklets

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Reported physical activity		Baseline, 3 months, and 6 months	No