Culturally and Linguistically Adapted Physical Activity Intervention for Latinas
Condition: Inactivity
Study type: Interventional

Summary: 
      The overall goals of this renewal are to replicate the findings of Seamos Saludables in
      Latina women, increase the effectiveness of the intervention, and measure
      intervention-related changes in clinical biomarkers. We will enhance the existing
      intervention by incorporating participant feedback (desire for greater interactivity and
      accountability), further targeting Social Cognitive Theory (SCT) constructs that were not
      influenced overall by the original intervention yet improved amongst our most successful
      participants (social support, outcome expectancies), and responding to changing trends and
      technology use in Latinos. We will conduct a clinical trial among Latina women in California
      randomized to either 1) the original Seamos Saludables tailored print only intervention or 2)
      a theory and text messaging-enhanced interactive technology based version of the Seamos
      Saludables intervention. We will also measure changes in cardiovascular and metabolic
      biomarkers (e.g., HbA1c, and LDL) to assess potential clinical impact of the intervention.
    

Detailed description: 
      Latinos are the largest racial/ethnic minority group in the U.S., and report substantial and
      widening health disparities. Prevalence of type II diabetes is 60-100% higher in Latinos than
      in non-Latino Whites, and incidence in Latinos is projected to increase by 500% by 20503. The
      largest disparities are projected for Latino women (Latinas). Rates of overweight and obesity
      are 23% and 37% higher in Latinas than in White women respectively, and have grown faster in
      Mexican American women, by far the largest subgroup of Latinas, than in White women during
      the past decade. Given that Latinos are projected to comprise nearly one-third of the US
      population by 2050, this signifies a pressing public health concern in terms of costs,
      diminished quality of life, and lost life years. Interventions are therefore needed that are
      not only linguistically adapted for this population but address their specific barriers.
      "Mediated" intervention delivery approaches (e.g., mail, phone, or web delivered) that
      emphasize home-based, lifestyle activities show larger effect sizes than face-to-face
      approaches, are more cost-effective, are likely more sustainable, and may be particularly
      appropriate for Latinas, as they reduce the burden of time, childcare, and transportation,
      barriers commonly cited by Latinas. Thus in the previously funded parent grant (R01NR011295)
      we responded to PAR-07-379, "Behavioral and Social Science Research on Understanding and
      Reducing Health Disparities," by modifying an existing print-based mail-delivered PA
      intervention and adapting it specifically for Latinas in the North Eastern U.S. with low
      acculturation, literacy, and socioeconomic status (SES), and testing the modified
      intervention in a randomized controlled trial (N=266). Participants in the PA intervention
      arm showed significantly greater increases in at least moderate intensity activity,
      increasing from 1.87 min/week at baseline to 73.36 min/week at 6 months (vs. 3.02 min/week to
      32.98 min/week in a contact control group). However, this is still well below the national
      guidelines of 150 minutes per week. This intervention therefore shows potential in promoting
      initial PA adoption, yet enhancements are needed to further help people achieve levels of PA
      that will prevent disease and reduce health disparities. The objectives of this renewal are
      to 1) enhance the intervention to achieve greater increases in PA, 2) assess its potential
      clinical impact by measuring changes in biomarkers, and 3) increase its generalizability by
      replicating it in Latina women, all of which would further the goal of designing an
      innovative behavioral intervention to promote health and prevent illness in diverse
      populations.
    

Intervention name(s): Original Tailored Intervention; Enhanced Tailored Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety).; Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Physical Activity; Latinas; Spanish-language; Text-Message; English-language; Exercise