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

Lifestyle Risk Reduction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03939754
• Other study ID #: AslVC.Med.18.02
• Status: Enrolling by invitation
• Start date: October 16, 2018
• Est. completion date: May 30, 2020

Study information

• Verified date: May 2019
• Source: Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 428
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lifestyle Risk Reduction

Intervention

Behavioral:
• Dedalo project
Physical activity, healthy food, socialization and mental activity promotion

Locations

Country	Name	City	State
Italy	Università degli Studi del Piemonte Orientale "Amedeo Avogadro"	Novara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Hobbs N, Godfrey A, Lara J, Errington L, Meyer TD, Rochester L, White M, Mathers JC, Sniehotta FF. Are behavioral interventions effective in increasing physical activity at 12 to 36 months in adults aged 55 to 70 years? A systematic review and meta-analysis. BMC Med. 2013 Mar 19;11:75. doi: 10.1186/1741-7015-11-75. Review. — View Citation

Lawton BA, Rose SB, Elley CR, Dowell AC, Fenton A, Moyes SA. Exercise on prescription for women aged 40-74 recruited through primary care: two year randomised controlled trial. BMJ. 2008 Dec 11;337:a2509. doi: 10.1136/bmj.a2509. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the intervention effectiveness in promoting healthy lifestyle	Lifestyle habits detection and description through a telephone-based questionnaire	12 month (April 2019 - April 2020)

External Links

•   Health promotion intervention
•   Italian surveillance of behavioral risk factors