Grenada Heart Project - Community Health Action to Encourage Healthy Behaviors
Condition: Health Behavior
Study type: Interventional
Phase: Phase 3

Summary: 
      The Grenada Heart Project (GHP) conducted an observational study within a randomly selected
      adult sample of Grenadians in 2008-2009. The aim of the study was to assess the clinical,
      biological and psychosocial determinants of the cardiovascular health in Grenada, in order to
      develop and implement a nationwide cardiovascular health promotion program.

      The sample of 2,827 adults was randomly selected from the national electronic voter list. The
      main outcome measures were self-reported cardiovascular disease and behavioral risk factors,
      anthropometric measures, blood pressure (BP), point-of-care testing for glucose and lipids,
      and ankle-brachial index. Analysis of the data revealed prevalence rates of obesity,
      hypertension and diabetes significantly exceeding those seen in the U.S.

      Since the completion of this assessment, an additional effort has contributed significantly
      to the current project. A parallel community health-promotion project was carried out in
      Cardona, Spain called the "Cardona Integral Fifty-Fifty" project with 80 subjects. The
      preliminary results of the Cardona study have a shown that peer motivation may significantly
      improve healthy behaviors and thus modify cardiovascular risk.

      The GHP CHANGE community -based intervention aims to promote positive behaviors and focus
      more on what creates health, rather than what prevents sickness. It is built on the
      foundations of social support, assessing whether people going through similar challenges will
      support each other, work together to identify and address barriers to success, and motivate
      each other to move forward. In this program we test for the impact of promotion of healthy
      lifestyle behaviors through peer motivation on blood pressure, physical activity, eating
      behavior, weight, and smoking.
    

Detailed description: 
      This culturally-tailored intervention program will take place over a 12-month period in the
      following four regions on the island:

        -  St. David's Parish

        -  St. Andrew's Parish

        -  St. George's Parish

        -  St. John's/St. Mark's Parish (combined ) •The program will involve approximately 400
           randomized participants (100 from each region). Participants, aged 18-70, from each
           parish will be divided into one of two groups: Intervention Group arm (peer support) or
           Control Group arm (individual study).

      The investigators will identify study participants previously enrolled in the Grenada Heart
      Project, with at least one vascular risk factor, as defined by the Adult Treatment Panel III
      guidelines which include: elevated BP, increased blood glucose level, increased waist
      circumference, minimal reported physical activity, minimally reported fruit and vegetable
      intake, or current smoking habits. Given a 10% refusal rate and 10% failure rate in the
      run-in phase, 120 participants from each site will be invited randomly, from the high risk
      group, to recruit for participation in the study.

      All eligible participants are invited to attend an informational half-day session, during
      which a general overview of the program is presented and participants have an opportunity to
      have any questions answered. During this session, eligible and interested individuals
      complete the written consent forms. Upon consenting, participants are informed of their
      randomization arm (education intervention or group intervention) and entered into a run-in
      phase. All participants receive a notebook, as well as certain health literate materials,
      provided by the American Heart Association. The educational materials will promote management
      of risk factors and the notebook will provide an avenue for recording of lifestyle behaviors,
      such as health goals, BP values, and eating habits.

      •Participants enrolled in the run-in phase will complete the following assessments at three
      time points (baseline, 6-months, and 12-months):

        -  Anthropometric measurements

        -  GHP data collection form

        -  International physical activity questionnaire (iPAQ)

        -  Lifestyle Assessment [modified SF-36 questionnaire tailored to the Grenadian population]

        -  Point-of-care testing using an LDX analyzer (solely for the 12 month assessment).

      The investigators have developed a "GHP Health outcomes Score" which captures a person's
      health profile on a 0-to-3 point scale related to smoking habits, overweight, sedentary
      lifestyle, and hypertension During the run-in phase, participants will attend a series of
      core lifestyle and risk factor education workshops related to motivation for change,
      nutrition (two sessions), smoking cessation, physical education and BP control. Only those
      participants who attend 4 of the 6 sessions will be eligible for randomization.

      Eligible participants will be randomized to the intervention arm or to the control arm,
      stratified by parish. In the group intervention arm a group leader will be selected
      internally within the support groups, who will receive additional training from the research
      team in regards to group motivation and facilitation. Those randomized into the Intervention
      arm will be organized into peer groups of approximately 10 persons.

      The specific aims of this study are:

      Specific Aim 1: Hypothesis: Individuals will show an improvement of health-related behaviors
      through directed peer education groups (intervention group), compared to the individuals not
      receiving such peer support (control group).

      Specific Aim 2: Hypothesis: Individuals will show an improvement in their quality of life
      through directed peer education groups (intervention group), compared to the individuals not
      receiving such peer support (control group).

      Specific Aim 3: Hypothesis: Individuals will show an improvement in cardiovascular risk
      factors through directed peer education groups (intervention group), compared to the
      individuals not receiving such peer support (control group).
    

Intervention name(s): Peer Groups
Intervention type(s): Behavioral
Intervention description(s): The intervention group arm will attend biweekly or monthly peer group meetings to discuss health successes and challenges.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cardiovascular health; behavior change; community-based; prevention