Tu Salud Si Cuenta Worksite: Pilot Intervention Study
Condition: Obesity; Physical Activity; Diet; Stress
Study type: Interventional

Summary: 
      Building on existing intervention strategies of the Tu Salud Si Cuenta media campaign, this
      proposed worksite pilot study will be testing a new feature by designing worksite promotion
      intervention strategies. The purpose of this study is to test the feasibility of a
      worksite-based physical activity and healthful food choice. The intervention will be among
      two worksites in the Lower Rio Grande Valley who employ primarily Mexican-American personnel.
    

Detailed description: 
      Obesity has not only been increasing over the past three decades (Wang & Beydoun, 2007; Wang
      & Zhang, 2002), it is predicted to increase in the future until by 2048 all American adults
      would be overweight (Wang, Beydoun, Liang, Caballero, Kumanyika, 2008). Moreover, the
      majority of Mexican American men and women are predicted to be overweight and obese by 2030
      (91.1% and 86.7% respectively).

      The proposed intervention research study is building from existing intervention strategies
      designed for the Mexican American population entitled Tu Salud Si Cuenta. This intervention
      highlights in the media successful role models who have changed their food choices and
      physical activity levels. In addition the intervention designs environmental changes to help
      community members carry out recommended behavior change strategies. Outcomes of interest for
      this study include increased physical activity so as to achieve the CDC/ACSM recommendations
      of 150 minutes of moderate to vigorous physical activity each week (Haskell et al., 2007),
      eating 5 servings of fruits and vegetables each day, reducing food portion sizes, and
      subsequent changes in biomarkers of health.

      This proposed worksite pilot study will be testing a new feature to the TSSC intervention by
      designing worksite promotion intervention strategies to promote physical activity and
      healthful food choices through environmental change strategies at the worksite. The same full
      scope of behavioral and clinical outcomes of interest will be examined in this pilot.

      The participants in this study will be male and female employees of two worksites, aged 18-65
      years. A convenience sample will be used for this study. Employees from State Department of
      Public Health Region 11 Harlingen Office or City of Brownsville will be recruited.
      Supervisors from both sites have provided letters of support for this project and have agreed
      to allow recruitment. Employees will be contacted with informational flyers and e-mails sent
      by the supervisors providing the letters of support. Interested adults will be sent an
      interest letter and informed consent. Data collection will proceed after the participant
      completes the informed consent form and provides documentation of physician's clearance to
      participate in physical activity.

      The purpose of this study is to test the efficacy of a worksite-based physical activity and
      healthful food choice, intervention among two worksites in the Lower Rio Grande Valley who
      employ primarily Mexican American personnel.

      Persons will complete consent forms during an enrollment/pretest period of 4 weeks. This
      period will include an electronic pre-test survey using Survey Monkey online software
      (Finley, 2008) completed by each participant. Additionally, clinical measures such as blood
      pressure, anthropometrics, fasting total cholesterol, triglycerides and glucose will be
      collected for each participant. These exams will be conducted by the trained staff from the
      clinical research unit and follow the identical procedures used for members of the Hispanic
      Health Research Cohort. Finally, in line with the Centers for Disease Control and Prevention,
      each participant will be encouraged to visit their personal physician and discuss
      participation in the recommended 150 minutes of physical activity per week.

      All individuals are given an exit interview with a registered phlebotomist or registered
      nurse to review immediate findings. All samples for laboratory testing and storage will be
      coded and identifiers removed. Participants will also provided with a written summary
      including their height, weight, waist circumference, blood pressure, fasting glucose,
      cholesterol and triglycerides. Values out of their expected range are flagged and referrals
      made as necessary. This interview is also used to address any questions or concerns that may
      be raised.

      Descriptive analyses will be used to compare the characteristics of the participants in the
      intervention and control groups that we intend to compare with respect to any outcome of
      interests, (e.g., blood pressure). Specifically, we will compare the groups with respect to
      demographic and socio-economic factors such as age, sex, ethnicity, and education level.
      Since the outcome measurements at baseline and the follow up quarterly visit (at 3 months, 6
      months, etc) are expected to be correlated, we will use Generalized Estimating Equations
      (GEE) models. GEE takes into account the correlation of an outcome measured repeatedly over
      time by treating it as a nuisance parameter (Zeger & Liang, 1986). As a result, the
      within-subjects correlation is not modeled explicitly. GEE uses a "working correlation" to
      treat the within-subjects correlation, and produces standard error estimates that take into
      account the correlation of responses with subjects. In addition, we will use Random effects
      models (Wolfinger & O'Connell, 1993) to adjust for the heterogeneity of subjects, which can
      be due to unmeasured predispositions, such as genetic factors, that account for the
      correlation within subjects across time. Estimated effects of a covariate of interest (e.g.,
      males vs. females) are adjusted for these individual differences and model estimates should
      be interpreted in terms of the change due to the covariate in an individual at a given level
      of random subject effect. The random effects model is most useful when inferences about
      individual differences are the primary interest. Random effects models have been developed
      for both continuous and binary outcome variables (Wolfinger et al., 1993).

      The study will take place over a 1 year time frame. Participants will have data collected
      prior to the intervention and four posttests at 3-month intervals. The immediate intervention
      group will receive the pilot worksite intervention for the initial 12 week period. The
      delayed intervention group will receive the pilot worksite intervention beginning in month 3
      of the study.
    

Intervention name(s): Tu Salud Si Cuenta Worksite Intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention will consist of providing TSSC newsletters to employees of the worksite. Additionally, informational sessions about physical activity and healthful food choice (consistent with the TSSC messages) during work hours will be implemented. Social support groups for the behavior changes will be established thru colleague networks. Individualized behavior change plans will be designed for enrolled participants. Additionally, environmental changes including a well equipped exercise facility on site and access to healthful foods in vending machines and work groups providing fruit and vegetable access in kitchen area will be implemented.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Feasibility of implementing TSSC in worksite environment