Seamos Saludables - Physical Activity Intervention Study for Latinas
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Wellness control; Physical Activity Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the Wellness Control arm of the study receive a variety of print materials focused on general health topics.; Participants in the Physical Activity Intervention arm of the study receive culturally-modified, individually tailored physical activity print materials.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: physical activity; Latinas