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

Sponsor
Università degli Studi del Piemonte Orientale "Amedeo Avogadro" (Other)
Overall Status
Unknown status
CT.gov ID
NCT03939754
Collaborator
(none)
428
1
19.4
22

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dedalo project

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 Design

Study Type:
Observational
Anticipated Enrollment :
428 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Dedalo Study Protocol: the Evaluation of a Community-level Multicomponent Lifestyle Intervention Effectiveness
Actual Study Start Date :
Oct 16, 2018
Anticipated Primary Completion Date :
May 30, 2019
Anticipated Study Completion Date :
May 30, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Evaluation of the intervention effectiveness in promoting healthy lifestyle [12 month (April 2019 - April 2020)]

    Lifestyle habits detection and description through a telephone-based questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Università degli Studi del Piemonte Orientale "Amedeo Avogadro" Novara Italy 28100

Sponsors and Collaborators

  • Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Investigators

  • Study Chair: Fabrizio Faggiano, Eastern Piedmont University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
ClinicalTrials.gov Identifier:
NCT03939754
Other Study ID Numbers:
  • AslVC.Med.18.02
First Posted:
May 7, 2019
Last Update Posted:
May 7, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 7, 2019