Peer-group-based Intervention Program

NCT02367963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 543

Last updated 2017-01-25

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Training period

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.

BEHAVIORAL

Peer-group

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.

Sponsors & Collaborators

  • Spanish Agency for Consumer, Nutrition and Food Safety (AECOSAN).

    collaborator UNKNOWN
  • Nutrition, physical activity and obese prevention Strategy (NAOS)

    collaborator UNKNOWN
  • Spanish federation for municipalities and provinces (FEMP).

    collaborator UNKNOWN
  • Foundation for Science, Health and Education, Spain

    lead OTHER

Principal Investigators

  • Valentín Fuster, MD, PhD · Chairman of the Foundation for Science for Health and Education

  • Emilia Gómez Pardo, PhD · Scientific Director Foundation for Science for Health and Education

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02367963 on ClinicalTrials.gov