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

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: Lifestyle Risk Reduction
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 428

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	Lifestyle habits detection and description through a telephone-based questionnaire	12 month (April 2019 - April 2020)

Collaborators and Investigators

• Sponsor: Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
• Investigators: Study Chair: Fabrizio Faggiano, Eastern Piedmont University

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Italian surveillance of behavioral risk factors
• Health promotion intervention

Study record dates

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