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Peer-group-based Intervention Program (Fifty-Fifty)

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ClinicalTrials.gov Identifier: NCT02367963
Recruitment Status : Completed
First Posted : February 20, 2015
Last Update Posted : January 25, 2017
Sponsor:
Collaborators:
Spanish Agency for Consumer, Nutrition and Food Safety (AECOSAN).
Nutrition, physical activity and obese prevention Strategy (NAOS)
Spanish federation for municipalities and provinces (FEMP).
Information provided by (Responsible Party):
Foundation for Science, Health and Education, Spain

Brief 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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Behavioral: Training period Behavioral: Peer-group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 543 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Comprehensive Lifestyle Peer-group-based Intervention on Cardiovascular Risk Factor, a Randomized Controlled Trial: Fifty-Fifty Program
Study Start Date : September 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Intervention
A Training period and a Peer-group intervention are asigned to this arm. Peer-group intervention 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.
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.

Control

A Training period intervention is asigned to this arm. Once the workshops have been carried out, the control group will be provided with written and visual documentation of risk factors and overall health habits. The members of this group will have access to the study website, where they will be able to find information on risk factors and health habits and links to the same websites related to health as the intervention group.

They won`t participate in the sessions of peer education group dynamics for a period of 12 months.

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.




Primary Outcome Measures :
  1. The improvement in a newly defined score combining 5 individual variables: the Fuster-BEWAT score [ Time Frame: 1,2 and 3 year follow-up after the intervention. ]
    The primary outcome measure is the mean change in the overall Fuster-BEWAT score, which assimilates scores related to Blood pressure, Exercise, Weight, Alimentation and Tobacco. The primary outcome is whether individuals belonging to a lifestyle intervention program (intervention group) demonstrate an improvement of health related behaviors and biological parameters compared to the self-management approach (control group).


Secondary Outcome Measures :
  1. The mean changes in the individual components of the Fuster-BEWAT score and the mean changes in systolic and diastolic blood pressure levels and Body Mass Index and in the habit parameters evaluated using validated questionnaires. [ Time Frame: 2 and 3 years ]

    Anthropometric data of the subjects such weight, height, waist circumference and blood pressure are measured.

    Information related to eating habits, smoking, physical activity, quality of life, and socio-demographic data is collected using questionnaires:

    • The standardized International Phisical Activity Questionnaire (IPAQ).
    • The shortened Fagerström dependency and the Richmond questionnaires regarding smoking.
    • The "Prevención con dieta mediterránea" (PREDIMED) validated 14-item screening tool for measuring adherence to the Mediterranean diet.
    • A reduced version of SF36 (health survey to measure the overall health) questionnaire for measuring the quality of life.
    • In addition, all participants are asked to provide socio-demographic and report on readiness to change or improving healthy behaviors.



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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must sign the informed consent and acknowledge the program's objectives.
  • Subjects must be born between 1963 and 1988 both inclusive.
  • Subjects must at least present one of the following characteristics:

    • To be overweight or obese: BMI ≥ 25 kg/m2
    • To be physically inactive: carry out less than 150 minutes of exercise a week for periods not less than 10 minutes
    • To be a smoker
    • To have high blood pressure

Exclusion criteria:

  • To be unable to meet any of the inclusion criteria
  • To have been pregnant in January 2013 or to get pregnant during the program
  • To have a history of any of the chronic diseases given below:

    • Cardiovascular disease
    • Cerebrovascular disease
    • Diabetes mellitus
    • Other metabolic or endocrine diseases requiring continuous treatment
    • Pathological oncology
    • Inflammatory bowel disease
    • Any other disease of chronic nature requiring continuous treatment with immunosuppressive drugs or corticosteroid therapy
    • Other reasons and any other disease after the baseline assessment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02367963


Locations
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Spain
Foundation for Science, Health & Education
Madrid, Spain, 28003
Sponsors and Collaborators
Foundation for Science, Health and Education, Spain
Spanish Agency for Consumer, Nutrition and Food Safety (AECOSAN).
Nutrition, physical activity and obese prevention Strategy (NAOS)
Spanish federation for municipalities and provinces (FEMP).
Investigators
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Study Chair: Valentín Fuster, MD, PhD Chairman of the Foundation for Science for Health and Education
Principal Investigator: Emilia Gómez Pardo, PhD Scientific Director Foundation for Science for Health and Education
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Foundation for Science, Health and Education, Spain
ClinicalTrials.gov Identifier: NCT02367963    
Other Study ID Numbers: SHE-001-FM
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: February 2016
Keywords provided by Foundation for Science, Health and Education, Spain:
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
Additional relevant MeSH terms:
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Cardiovascular Diseases