Dedalo Study Protocol: the Evaluation of a Community-level Multicomponent Lifestyle Intervention Effectiveness

May 3, 2019 updated by: Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
The reduction of non-transmissible diseases (NCDs) is a community health priority and many NCDs are lifestyle related. In order to promote healthy lifestyle in Vercelli, the Local Health Authority (ASL) and the municipality of Vercelli and the University of Novara have realized the Dedalo project: a multicomponent community intervention. In Italy, few are the study evaluating the effectiveness of the multicomponent community intervention. Thus, aim of the study is to evaluate the effectiveness of Dedalo project in promoting lifestyle healthier change in the adult lifestyle general population in Vercelli.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND. The reduction of the non-transmissible diseases (NCDs) is a priority for the health community and for the economical sustainability of the healthcare system. In fact, the NCDs are the main global cause of death. It is demonstrated that many NCDs are lifestyle related; notable, even small lifestyle changes bring a health outcome improvement. The Italian epidemiological survey PASSI (2013-2016) reveals that the 33% of the population aged 50-69 years old living in Vercelli is self-declared sedentary and the 45% is overweight/obese. The Dedalo project, started in March 2018, is finalized to promote evidence-based healthy behaviors in the Vercelli adult population. In Italy the studies of community multicomponent prevention interventions are few. In this regard, the aim of the study is to evaluate the Dedalo project efficacy in the promotion of lifestyle changes.

MATERIALS AND METHODS. The study is a prospective observational one. The socio-economical and behaviors information are detected through an ad hoc questionnaire. The questionnaire is telephone-administered to the population who attended Dedalo activities and to an adult general population sample (40-75 years old) living in Vercelli. The same questionnaire will be administered 12 months later the first interview.

EXPECTED RESULTS. In April 2018 the socio-economics and behaviors description of both the studied population will be available. The fist evaluation of behavioral change will be concluded in April 2019.

CONCLUSIONS. The study will allow to define the efficacy of the community prevention intervention Dedalo is behavioral changes promotion, its capability in involving all the target population promoting equality in health and to improve the community prevention interventions.

Study Type

Observational

Enrollment (Anticipated)

428

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Novara, Italy, 28100
        • Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult population living in Vercelli municipality aged 40-75 years old. The cohort consists in two sample: 214 person who attended at least one Dedalo activity, 214 person randomly selected from the ASL register of Vercelli.

Description

Inclusion Criteria:

  • adult population living in Vercelli municipality

Exclusion Criteria:

  • inability to understand the Italian language
  • inability to answer to the telephonic interview
  • denial of the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult attendance to Dedalo activities
Adult attended one Dedalo's activity
Behavioral: Dedalo project
Physical activity, healthy food, socialization and mental activity promotion
Adult living in Vercelli
Adult aged 40-75

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the intervention effectiveness in promoting healthy lifestyle
Time Frame: 12 month (April 2019 - April 2020)
Lifestyle habits detection and description through a telephone-based questionnaire
12 month (April 2019 - April 2020)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Investigators

  • Study Chair: Fabrizio Faggiano, Eastern Piedmont University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 16, 2018

Primary Completion (ANTICIPATED)

May 30, 2019

Study Completion (ANTICIPATED)

May 30, 2020

Study Registration Dates

First Submitted

May 3, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (ACTUAL)

May 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • AslVC.Med.18.02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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