Peer-group-based Intervention Program

NCT02367963 | Completed

• 1 other identifier: SHE-001-FM
• Study Type: interventional
• Target: 543
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

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

Outcome Measures

Primary Outcomes (1)

• The improvement in a newly defined score combining 5 individual variables: the Fuster-BEWAT score

  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).

  1,2 and 3 year follow-up after the intervention.

Secondary Outcomes (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.

  2 and 3 years

Study Arms (2)

Intervention

EXPERIMENTAL

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; Behavioral: Peer-group

Control

OTHER

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

Interventions

Training period BEHAVIORAL

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.

Control; Intervention

Peer-group BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation for Science, Health and Education, Spain: lead
• Spanish Agency for Consumer, Nutrition and Food Safety (AECOSAN).: collaborator
• Nutrition, physical activity and obese prevention Strategy (NAOS): collaborator
• Spanish federation for municipalities and provinces (FEMP).: collaborator

Study Sites (1)

Foundation for Science, Health & Education

Madrid, Spain, 28003, Spain

Location

Related Publications (2)

• Fernandez-Alvira JM, Fernandez-Jimenez R, de Miguel M, Santos-Beneit G, Bodega P, Hill CA, Carral V, Rodriguez C, Carvajal I, Orrit X, de Cos-Gandoy A, Dal Re M, Robledo T, Fuster V. The challenge of sustainability: Long-term results from the Fifty-Fifty peer group-based intervention in cardiovascular risk factors. Am Heart J. 2021 Oct;240:81-88. doi: 10.1016/j.ahj.2021.06.006. Epub 2021 Jun 18.

  PMID: 34147462 DERIVED

• Gomez-Pardo E, Fernandez-Alvira JM, Vilanova M, Haro D, Martinez R, Carvajal I, Carral V, Rodriguez C, de Miguel M, Bodega P, Santos-Beneit G, Penalvo JL, Marina I, Perez-Farinos N, Dal Re M, Villar C, Robledo T, Vedanthan R, Bansilal S, Fuster V. A Comprehensive Lifestyle Peer Group-Based Intervention on Cardiovascular Risk Factors: The Randomized Controlled Fifty-Fifty Program. J Am Coll Cardiol. 2016 Feb 9;67(5):476-85. doi: 10.1016/j.jacc.2015.10.033. Epub 2015 Nov 9.

  PMID: 26562047 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Behavior

Study Officials

• Valentín Fuster, MD, PhD

  Chairman of the Foundation for Science for Health and Education

  STUDY CHAIR

• Emilia Gómez Pardo, PhD

  Scientific Director Foundation for Science for Health and Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 20, 2015
• Study Start: September 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 25, 2017

Record last verified: 2016-02

Locations

ES (1)