Tu Salud Si Cuenta: UT Community Outreach Program for Community-based Diabetes Prevention and Control.
Condition: Diabetes, Obesity
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Building from existing intervention strategies designed for the Mexican American population
      entitled Tu Salud Si Cuenta(TSSC) or Your Health Matters. 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. The purpose of this study is to test the
      efficacy of the outreach elements of the Tu Salud Si Cuenta (TSSC) media campaign, a physical
      activity and healthful food choice intervention among Mexican Americans in the Lower Rio
      Grande Valley to achieve behavioral and clinical outcomes.
    

Detailed description: 
      The proposed intervention research study is building from existing intervention strategies
      designed for the Mexican American population entitled Tu Salud Si Cuenta (TSSC) or Your
      Health Matters. 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.

      To test the efficacy of the outreach components of this campaign we are proposing a
      behavioral intervention trial with two study arms: 1) media campaign or 2) media campaign
      plus promotora outreach. Data will be collected from the 500 newly enrolled members of the
      Cameron County Hispanic Cohort, each member from a different household and primarily from
      quartiles two and four. The measures of this group will be the standard measures collected
      from the cohort including their medical history, clinical measures and behavioral measures.
      Two additional measures specified in this proposal will be obtained.

      Participants assigned to the TSSC media campaign-only arm of the study will receive a welcome
      TSSC newsletter upon enrollment to the study, and will receive the same exposure to the TSSC
      media campaign as other community members not enrolled in the behavioral intervention trial.
      This includes exposure to the campaign when at the Clinical Research Unit for CCHC data
      collection via possible viewing of TSSC television segments in the waiting area, and
      availability of TSSC newsletters. Other possible TSSC campaign exposure will occur as it does
      for the general public via radio, television and website, using the walking trials, going to
      farmers market, etc.

      Participants assigned to the Promotora plus arm of the study will also receive the initial
      welcome TSSC newsletter, and other media campaign materials to assure that they are aware of
      the various media outlets and programming of the campaign. In addition, they will receive a
      promotora home visit within two weeks of their enrollment. The home visit will consist of the
      promotora delivering that month's TSSC newsletter, reviewing the newsletter with the
      participant, emphasizing the role model story, discussing physical activity and healthful
      food choices using motivational interviewing strategies. These strategies allow the community
      member to discuss their own goals for making change on these issues while the promotora
      reflectively listens and summarizes their comments. During the home visit, the promotora will
      also invite the participant to relevant and accessible opportunities for physical activity
      and healthful food choices, such as neighborhood walking groups, exercise classes, Farmers'
      Market, nutrition and cooking classes. Subsequently a monthly home visit will be made by a
      promotora to deliver the TSSC newsletter, and to follow-up on the initial conversation and
      referrals. Monthly visits will be made to all 250 participants in the promotora plus arm of
      the study. Other tools and resources the promotoras might use at the home visits might
      include showing the participant how to access recipes and resources on the TSSC website,
      viewing relevant TSSC TV clips on a laptop. Participants will also be invited to an annual
      celebration of the TSSC media campaign which will feature speakers, cooking and exercise
      demonstrations and opportunities for networking.

      The purpose of this study is to test the efficacy of the outreach elements of the Tu Salud Si
      Cuenta (TSSC) media campaign, a physical activity and healthful food choice intervention
      among Mexican Americans in Lower Rio Grande Valley, to achieve behavioral and clinical
      outcomes.

      Information will be collected from the participants and will be followed every five years
      under their current cohort protocol.

      Data of additional behavioral and clinical measures from these participants will be taken
      annually for up to five years following the same protocol as used for all CCHC participants
      and specifically collecting the measures below.

      All participants are invited to the Clinical Research Center for Clinical and Translational
      Sciences (CRC-CTSA) or if they prefer, visited in their home. Following a 10 hour fast, 2
      EDTA vials (20 cc) of blood will be collected from a peripheral vein (antecubital fossa).
      Participants are offered a small snack. Blood samples are placed on ice immediately and
      processed for cholesterol and triglyceride levels using Cardiochek bioscanners and test
      strips (Polymer Technology Systems, Inc. Indianapolis, IN). Plasma glucose is measured using
      a YSI 2300 STAT PLUS-D instrument (YSI, Inc. Yellow Springs, OA). Complete blood count with
      differential white blood counts is performed on whole blood using a Beckman coulter Ac-T diff
      analyzer (Beckman-Coulter, Inc. Fullerton, CA). Both EDTA tubes are centrifuged at 4.0 C in a
      refrigerated centrifuge at 4oC (Labnet International, Inc. Edison, NJ) at 1200 relative
      centrifugal force for 12 minutes. Plasma is separated, aliquoted and immediately frozen at
      -70° in more than one freezer at UTSPH-B field research laboratory.

      Total cholesterol and triglycerides and lipid profiles are assayed. High Density Lipoprotein
      (HDL) cholesterol is determined using the precipitation method. Low Density Lipoprotein (LDL)
      cholesterol is calculated by the Friedewald equation modified to use the factor of
      triglycerides/5 for adults. In all cases LDL is estimated if triglycerides are less than or
      equal to 400 mg/dl. Insulin is measured using radioimmunoassay (Diagnostic Products, Inc.,
      Los Angeles, CA) and insulin resistance is calculated using the HOMA equation.

      Total glycosylated hemoglobin and Hemoglobin A1c are measured using the principle of boronate
      affinity and high-performance liquid chromatography (HPLC) and be performed by the clinical
      laboratory of the Valley Baptist Medical Center (Harlingen, TX). C-reactive protein (CRP) is
      measured at the UTSPH-B field research laboratory using ELISA (Alpha Diagnostics Intl. Inc.
      San Antonio, TX) with external quality control performed on randomly selected samples at the
      Section of Atherosclerosis and Lipoprotein Research located in Baylor College of Medicine
      (Houston, TX). IL6 and TNFα will be performed using Elisa at the UTSPH-B field research
      laboratory (BD Biosciences, San Jose, CA).

      Survey information is collected from the participants in an interview format during their
      clinical visit as well. These surveys are conducted throughout the visit to ensure that the
      CCHC participant time is used wisely. All persons collecting the survey information are
      trained and monitored. Behavioral and awareness measures are collected. Clinical measures
      collected from the CCHC participants will be used in this proposed study as well.

      All individuals are given an exit interview to review immediate findings. Participants are
      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 and uses motivational interview strategies to
      discuss goal setting.

      In addition to the information regularly collected during an enrollment visit to the Cameron
      County Hispanic Cohort, participants consented for this study will also be asked to complete
      two additional questionnaires: Diabetes Knowledge and Health Care Utilization

      Course of Study: The study will take place for up to 5 years. Participants will be approached
      for participation in this study as they come for their scheduled visit to the Clinical
      Research Unit in Brownsville. They will be newly enrolled members of the cohort. Cohort
      participants are enrolled by selecting random census tracts and random census blocks. All
      households in the selected census block are eligible to participate in this study but, to
      avoid clustering within the same household, we plan to select only one household member
      between age 18-75 to participate in this study. This creates a model where neighbors are
      enrolled in the cohort. This also allows for neighborhood-based (census block) intervention
      programming to be conducted by the promotoras. We will be offering referrals to our TSSC
      exercise groups and walking groups located in the TSSC plus intervention arm blocks as well
      as regular visits by the promotoras to discuss media and newsletters using Motivational
      Interviewing Strategies.
    

Intervention name(s): Tu Salud Si Cuenta Behavioral Intervention
Intervention type(s): Behavioral
Intervention description(s): A behavioral intervention to assess the impact of the TSSC Media Campaign intervention outreach components with two study arms. The first arm is comprised of participants enrolled in the TSSC Media Campaign(control group) and the second arm(intervention group)consisting of participants exposed to media campaign who will be exposed to additional outreach efforts by monthly visits from lay health workers.
Other intervention name(s): TSSC Media Campaign Plus Refined Promotora Outreach group.(intervention group); TSSC Media Campaign ONLY group. (Control group)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Physical Activity, Mexican-American, Obesity, Diabetes, Nutrition, Border Health