Seamos Saludables - Physical Activity Intervention Study for Latinas

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dr.Bess Marcus, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01583140
First received: March 6, 2012
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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 Intervention
Sedentary Lifestyle
Behavioral: Wellness control
Behavioral: Physical Activity Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Culturally and Linguistically Adapted Physical Activity Intervention for Latinas (Seamos Saludables)

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 312
Study Start Date: October 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

In the U.S., Latinos report higher rates of inactivity and related health conditions (e.g., hypertension,hypercholesteremia, obesity, heart disease, stroke, diabetes) than non-Hispanic whites. Furthermore, Latino women (Latinas) report higher rates of sedentary behavior than Latino men. Due to cultural factors, socioeconomic circumstances, differences in educational background, and language barriers, Latinos in general, and especially Latinas, have limited access to public health interventions that promote physically active lifestyles. To address this public health crisis, effective interventions that leverage state-of-the-art theory and methods are needed. The investigators research group has 20 years experience developing and evaluating individually tailored computer expert system-driven physical activity interventions (based on Social Cognitive Theory and the Transtheoretical Model). In the investigators recent pilot study (R21NR009864), the investigators culturally and linguistically adapted the existing tailored intervention for sedentary Latinas and conducted a small randomized trial of the modified program (N=94). Six month (post-intervention) assessments are still ongoing, but three month data have been collected on 87 participants (93% retention). Intervention participants increased their physical activity from a mean of 17 minutes per week (SD=25.8) at baseline to 92 minutes (SD=69.8) at three months, whereas contact control participants reported increasing their physical activity from 12 minutes per week (SD=21.8) at baseline to 64 minutes (SD=84.3) at three months. The trends in the means at 3 months lend preliminary support for the efficacy of the intervention and the high retention rates, especially for a study targeting a hard-to-reach group like Latinas, bode well for its feasibility and acceptability. For the current proposal, the investigators will build on these encouraging results by conducting an adequately powered (N=312) randomized controlled trial to test the efficacy of the culturally and linguistically modified, individually tailored print intervention compared with a wellness contact control condition (e.g., cardiovascular health information from NHLBI in Spanish). Data will be collected at baseline, 6, and 12 months using well-established physical activity measures (7-Day PAR, Actigraphs), as well as a comprehensive set of psychosocial questionnaires. 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. The investigators will also examine the maintenance of treatment effects at 12 months, costs of delivering the tailored intervention program, and potential mediators and moderators of the intervention-physical activity relationship. In the proposed study the investigators seek to promote physical activity among this at-risk population using a high-reach, low-cost strategy, which has great potential for adoption on a larger scale and thus high potential for reducing existing health disparities in the U.S.

  Eligibility

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

Inclusion Criteria:

  • Females
  • Generally healthy
  • Sedentary (Less than 60 minutes per week of mod or vigorous physical activity)
  • Latina (self-defined)
  • Must be able to read and write Spanish fluently
  • 18 - 65 years of age
  • Planning on living in the area for the next 12 months

Exclusion Criteria:

  • Pregnant or planning on becoming pregnant
  • BMI greater than 45
  • Not able to walk continuously for 30 minutes/limited ability to complete daily activity or ability to exercise
  • Exercise is against advice of doctor
  • Heart disease/treatment
  • Heart murmur
  • Angina/chest pain or Angina/chest pain with exertion
  • Palpitations
  • Stroke/TIA
  • Peripheral vascular disease
  • Diabetes I or II
  • Chronic Infectious Disease - HIV, Hepatitis
  • Chronic liver disease
  • Cystic fibrosis
  • Abnormal EKG on last EKG performed
  • Emphysema, Chronic bronchitis, COPD
  • Seizure in past year
  • Surgery in past year on heart, lung, joint, orthopedic surgery
  • Surgery pending in next year on lung, joint, orthopedic surgery
  • Unusual/concerning shortness of breath
  • Asthma
  • High blood pressure/high blood pressure medication
  • Abnormal medical Stress Test
  • musculoskeletal problems
  • Fainting/dizziness more than 3 times in past year OR interferes with daily activities OR causes loss of balance
  • Cancer treatment in past 3 months
  • Hospitalized for psychiatric disorder in past 3 years or suicidal
  • 3 or more alcoholic beverages 5 or more days per week
  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: NCT01583140

Locations
United States, Rhode Island
Brown University Institute for Community Health Promotion
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Bess H Marcus, Ph.D. University of California, San Diego
  More Information

Publications:
Responsible Party: Dr.Bess Marcus, Professor and Chair, Department of Family and Preventive Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01583140     History of Changes
Other Study ID Numbers: SALUDABLES-2009, 5R01NR011295
Study First Received: March 6, 2012
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014