Peer-group-based Intervention Program
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Cardiovascular disease is the leading cause of death in Spain and worldwide. Interventions
      targeting dietary patterns, weight reduction and new physical activity habits often result in
      impressive rates of initial behavior changes, but frequently these are not translated into
      long term maintenance. We hypothesize that a peer-group intervention, addressing multiple
      facets of cardiovascular disease risk factor can be successfully implemented improving the
      adherence of participants to healthy habits.

      A multicenter, randomized control trial scheme was adopted. A peer-group based intervention
      approach in which community members support each other to promote health-enhancing changes
      was chosen. Around 600 participants from 7 Spanish municipalities received a 12h initial
      training and were randomly allocated to intervention or control groups for a 12-month peer
      intervention. Baseline measurements took place before and after the initial training.
      Follow-up measurements will be taken at the end of the intervention and 1 and 2 years after
      the end of the study. The primary outcome is the improvement in a newly defined score
      combining 5 individual variables. Secondary outcomes are 1, 2 and 3 years variations in
      anthropometric parameters and/or healthy behaviors.

      The project seeks the empowerment of subjects from 25 to 50 years of age to improve their
      overall health habits and self-control of risk factor through peer education. The initiative
      is being developed in cooperation with the Spanish Agency for Consumer Affairs, Food Safety
      and Nutrition (AECOSAN). This study will allow the economic and feasibility evaluation of the
      intervention, which will enable policy makers to consider its potential wider implementation
      for a real community-based intervention.
    

Detailed description: 
      Cardiovascular disease is the leading cause of death in Spain and worldwide. Obesity,
      smoking, physical inactivity and high blood pressure act as major risk factors. Although
      these major risk factors cannot be necessarily eliminated developing healthy habits and
      behaviors can reduce the possibilities of heart attacks.

      The hypothesis of the project focuses on the thought that if adults are trained, among peers,
      and are provided with new knowledge, skills and attitudes on a healthy lifestyle their
      cardiovascular health and self-control of risk factors will improve.

      The main objective of this comprehensive intervention is to explore the evolution of multiple
      cardiovascular diseases, risk factor including blood pressure, body mass index (BMI) and
      waist circumference.

      The project is a pilot study for a community intervention, multicenter, randomized,
      controlled and longitudinal in nature for a period of 15 months, lasting the intervention 12
      months. Besides, the project entails a follow-up after 2 year.

      The overall approach of the study is as follows:

        1. Recruitment: For participant recruitment, town council representatives were contacted by
           the management team and a strategy was designed for the publicity of the project among
           the town population. A representative from the town council designed as the coordinator
           for the local municipality works in close collaboration with the project team. Once
           potential subjects were identified, a recruiting meeting was held in which the overall
           project objective is presented.

        2. Inclusion: Volunteers that expressed their interest in participating in the program were
           examined for inclusion criteria. Eligible participants are aged 25-50 and present at
           least one of the following cardiovascular risk factor and/or lifestyle-related risk
           factor: hypertension (≥140/90 or ≤140/90 under treatment), overweight or obesity (BMI
           ≥25), smoking (Smoker), or physical inactivity (≤150min/week).

           Those acceptable were included and registered at the program's website. A more detailed
           and in-depth explanation of the program was then given to the selected subjects in a
           second meeting. Afterwards subjects were invited to sign the informed consent and to
           acknowledge the program's objectives.

        3. Baseline Assessment (A1): the physical annotations of the subjects are carried out.
           Variables such weight, height, waist perimeter and blood pressure and the calculation of
           the BMI are measured. Additionally information related to eating habits, smoking,
           physical activity, quality of life, and socio-demographic data is collected using the
           online questionnaire.

           All participants followed a training period consisting on six workshops in which
           education on health habits and encouragement to reduce risk factors was promoted.
           Workshops addressed rigorous, accurate and effective technical information but were
           tailored to general public to ensure that subjects became aware of the importance of
           change in their overall health.

        4. Assessment 2 (A2): after two months and the workshops' completion, at which contact
           details are reassured and the non-occurrence of any of the exclusion criteria is
           confirmed, repeated measures of body weight, waist perimeter, blood pressure and
           surveyed habits are assessed.

           After the training period, those who did not attend the workshops and the second
           assessment were excluded from the study. The remaining accepted participants were then
           randomized to either control or interventional groups using the sex as stratification
           factor to ensure that the groups were balanced by sex.

           To promote reduction of cardiovascular diseases risk, the Fifty-Fifty program uses
           evidenced-based recommendations for cardiovascular diseases prevention.

           The intervention is designed to promote the active participation of subjects in their
           own healthcare. The ultimate goal of the program, and specifically that of the
           intervention, is to reinforce the self-accountability of the subjects and nurture their
           self-care. The approach for health promotion is the peer education, in which community
           members support themselves promoting health-enhancing changes among peers.

           The participants are randomly assigned to subgroups for the intervention. The
           intervention is initiated by health, education and psychology professionals who help
           recruiting two volunteers from each subgroup to serve as peer educators or leaders.

           For selecting the leaders, each subgroup goes through a preset group-dynamics education
           directed by an expert psychologist, for assessing group members for leadership,
           availability for the role and clear understanding of the intervention. For preparing the
           chosen leaders as peer educators, they are trained in a 3-hour session on relevant
           health and health-promotion information, leadership and communication skills.

           Twelve peer-group meetings will be held on a monthly basis and each meeting will last
           for 60-90 minutes. The activities involved in the group dynamics will include, at their
           own choice, group discussions, role-playing, brainstorming, relaxation techniques, menu
           design, joint sportive activities, and others. These activities will directly stimulate
           the incorporation of healthy habits by participants and will enhance their confidence in
           their ability to manage risk factor and problems arising from healthy habits. At each
           meeting, participants will address emotion management, problem resolution, relapse
           prevention, diet control and physical activity engagement. Through these reflections
           participants will propose affordable goals that will improve their life style.

           As a fundamental instrument for increasing awareness on healthy habits and self-control
           of cardiovascular diseases risk factor, participants are provided with a health handbook
           to register their health parameters and will record their immediate goals at each group
           meeting. Progress and new goals will be discussed in the context of the whole group.

           An important aspect of the program is empowering individuals for the self- monitoring of
           blood pressure. Blood pressure is a main target of the intervention and is directly
           related to most healthy habits specifically targeted in this study. Automated blood
           pressure measuring devices will be donated to participants for their own use and
           appropriate training on the use of the devices is provided. Through this action
           participants will then directly control a fundamental aspect of their cardiovascular
           diseases risk. Due to its special relevance, a specific blood pressure registry card
           will be provided for the follow up of participants blood pressure during the whole
           study.

           In addition, for increasing the awareness on their situation and evolution, participants
           receive a copy of the score card in which the objective evaluation of their
           cardiovascular diseases risk factor is determined.

        5. Assessment at the end of the 12-month intervention (A3): this assessment is carried out
           upon the 15-month duration of the study. Again contact details are reconfirmed and
           repeated measures such as body weight, waist perimeter, blood pressure and surveyed
           habits are collected.

        6. Assessment (A4): this assessment is carried out one year after the intervention.

        7. Final assessment (A5): this assessment is carried out two year after the intervention.

      Data obtained:

        1. Anthropometric data: blood pressure, weight, height and waist circumference.

        2. Healthy habits are collected by standardized questionnaires

        3. Self-controlled blood pressure (BP) data are also obtained in the intervention group. A
           frequency of self-measures (2 per day -2 days per week - 2 weeks per month) is intended
           and will generate a total of 96 measures.

      Data registry: the SHE Foundation owns the project database. It is registered with the
      Spanish Agency for Data Protection under the name of the Fifty-Fifty Program.

      A responsible for the database coordinates the management of the all data arising from the
      study and monitors the quality control.

      Personal data will be introduced by each of the subjects at the time of registration. Once
      this data is included in the web application and a subject is selected by the research team,
      the computer system will send a code and password to each of them ensuring the anonymity of
      the assessment data arising from the study. If a subject has any troubles accessing the
      database information the responsible is there to facilitate his/her accessibility.

      The data from the physical assessment-weight, height, waist perimeter, blood pressure-will be
      collected by those trained for the purpose, and will be uploaded into the system; again,
      ensuring the highest standards of confidentiality and security. The data collected will be
      verified by the responsible for the database.

      An essential part of the study is data anonymization to comply with current regulations and
      legislation. At the moment that the subject enters the study, the system will assign him/her
      an identification (ID) number that will be unique and exclusive to that subject. Each
      subject's visit will be recorded by a code associated with his/her ID number. This will
      guarantee that the information appearing in a list is anonymous and cannot be credited to any
      specific individual.

      The processing of the data will conform to the provisions of the Organic Law 15/1999,
      December, 13, regarding the protection of personal data. Access to the subject information is
      restricted to a very limited part of the staff involved in the study, but always maintaining
      absolute confidentiality thereof and complying with current legislation therefrom.

      The website database will contain all the study information including data from different
      explorations, survey information and data on the progress of the scores of both the initial
      and longitudinal phases of the study. The database will be centralized and will be unique to
      avoid redundancies and inconsistencies. The information contained in the database will have
      followed a rigorous quality control.

      Ethical concerns: Informed written consent for participation is required from the
      participants to become part of the study. The written consent specifies the purpose of the
      study and the intervention, test and measures that are going to be taken. Participants are
      also notified that withdrawal at any time is immediate and without any consequences. We
      assure the confidentiality of all the data submitted and measures taken from the
      participants. The information collected is treated according to the organic law 215/1999 for
      the protection of personal data. Ethical approval was received from a committee of reference.

      Statistical analysis: The percentage of individuals in the intervention and control groups
      who substantially improve their health habits will be estimated. Based on power calculations,
      a difference of at least 15% between the intervention and control groups will be detected.
      Assuming and approximate 10% loss to follow-up and/or refusal to participate, the minimum
      number of subjects needed in each group to detect this change is 250 participants.

      A descriptive analysis of the population based on selected variables will be carried out at
      baseline and follow up. The prevalence of overweight, obesity, hypertension, smoking,
      physical inactivity and adherence to Mediterranean diet in both groups by sex and age (from
      25 to 34 and 35 to 50 years) in each of the 3 assessments will be calculated. Total
      Fuster-BEWAT score (combination of 5 variables: blood pressure, exercise, weight,
      alimentation and tobacco) values will be computed. The percentages of subjects who have
      increased their total score from the beginning of the program to its completion will be
      determined. A comparison test of proportions for independent samples will be used to assess
      whether significant changes have occurred in the total score and in the various dimensions of
      the score, assuming as statistical significance the value of p<0.05. Student's t-test will be
      used to assess whether the average score at the end of the program is significantly different
      in both intervention and control groups.
    

Intervention name(s): Training period; Peer-group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Six workshops in which education on health habits and encouragement to reduce risk factors was promoted. Workshops addressed rigorous, accurate and effective technical information but were tailored to general public to ensure that subjects became aware of the importance of change in their overall health. Workshops led by experts dealt with the following relevant subjects: Motivation to Change; Physical Activity, Healthy Diet, Smoking Cessation; Stress Management and Self-control of Blood Pressure.; The ultimate goal is to reinforce the self-accountability in the subjects and nurture their self-care. It is designed to make the subjects participate actively in their healthcare. Through the different activities subjects will begin to successfully make various changes that increase their confidence in the ability to manage risk factors and problems arising from unhealthy habits. Along the twelve sessions (60-90 minutes) subjects propose assumable health goals; learn to manage their emotions, to resolve problems, to control their diet, to increase their physical activity, to control their state of mind and how the acquisition or not of healthy habits influences their relationships.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Peer education; Comprehensive health intervention; Lifestyle; Adult; Mid age; Male; Female; Human; Clinical trial; Prevention and control; Cardiovascular Disease; Behavior; Risk Factors; Healthy lifestyle; Healthy people program; Peer-group