Condition category
Mental and Behavioural Disorders
Date applied
27/01/2010
Date assigned
22/06/2010
Last edited
08/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elisabetta Chellini

ORCID ID

Contact details

Cancer Prevention and Research Institute
Unit of Environmental and Occupational Epidemiology
Via San Salvi
12
Florence
50135
Italy
e.chellini@ispo.toscana.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TOSC1

Study information

Scientific title

Randomised controlled trial for evaluating a brief counselling intervention on physical activity and smoking cessation to smoking women undergoing to the National Health System Cervical Cancer Screening Program (NHS-CCS-Prog) in Tuscany (Florence area), Piedmont (Turin), Emilia-Romagna (Cesena), and Lombardy (Mantua) regions

Acronym

SPRINT Study

Study hypothesis

1. To verify whether the smoking cessation counselling intervention delivered to women randomly assigned to the "smoking" intervention arm, could increase the one-year cessation rate, in comparison to that recorded in women randomly assigned to the control arm
2. To verify whether the counselling interventions on smoking cessation and physical activity delivered to women randomly assigned to the "smoking and physical activity" intervention arm, could increase the one-year cessation rate, in comparison to that recorded in women randomly assigned to the control arm, or to the "smoking" intervention arm

Ethics approval

Ethics Committee of the Local Health Authority of Florence, Italy, approved on the 5th May 2009

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Smoking cessation in adults (women)

Intervention

The smoking cessation intervention in the "smoking" and in the "smoking and physical activity" arms is tailored according to the DiClemente-Prochaska stage of change on smoking behaviour. The stage of motivational change of each participating woman is obtained from the study questionnaire that participants have to fill in while waiting for the Pap test. The counselling intervention corresponds to the first two phases of the brief intervention for smoking cessation ("Ask" and "Advice"). It takes about 2 - 3 minutes.

The physical activity intervention in the "smoking and physical activity" arm is tailored according to the DiClemente-Prochaska stage of change regarding physical activity. The stage of motivational change of each participating woman is obtained from the study questionnaire, that participants have to fill in while waiting for the Pap test. The counselling on physical activity is a brief intervention, and takes about 4 - 5 minutes.

The smoking cessation and physical activity interventions are delivered by trained midwives during the Pap-test examination, that takes about 15 - 20 minutes per attending woman.

Participating women have also to fill in an informed consent attached to the study questionnaire they have to fill in while waiting for the Pap test.

A self-help booklet on physical activity and smoking cessation is provided to all participants to the study.

A telephone follow-up of all participants is scheduled after six months and one year from the intervention, in order to evaluate how many women quit smoking after the intervention.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Six-month smoking cessation rate

Secondary outcome measures

Stages of motivational change according to the DiClemente-Prochaska Transtheoretical Model of Change, measured before the interventions and after 6 months with a structured questionnaire delivered to participants to the study

Overall trial start date

01/09/2009

Overall trial end date

30/11/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Smoking women aged 25 - 64 years old
2. Attending the NHS-CCS-Prog Consulting Rooms located in Florence, Turin, Cesena, and Mantua areas

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1,350 smoking women

Participant exclusion criteria

1. Non-smoking and former smoking women aged 25 - 64 years old
2. Women aged less than 25 years old or more than 64

Recruitment start date

01/09/2009

Recruitment end date

30/11/2011

Locations

Countries of recruitment

Italy

Trial participating centre

Cancer Prevention and Research Institute
Florence
50135
Italy

Sponsor information

Organisation

Ministry of Health, Rome (Italy)

Sponsor details

Viale Giorgio Ribotta 5
Rome
00144
Italy
m.distefano@sanita.it

Sponsor type

Government

Website

http://www.ministerosalute.it/index.jsp

Funders

Funder type

Government

Funder name

Ministry of Health, Rome (Italy) - Lombardy Region

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22950883

Publication citations

  1. Results

    Gorini G, Carreras G, Giordano L, Anghinoni E, Iossa A, Coppo A, Talassi F, Galavotti M, Chellini E, , The Pap smear screening as an occasion for smoking cessation and physical activity counselling: effectiveness of the SPRINT randomized controlled trial., BMC Public Health, 2012, 12, 740, doi: 10.1186/1471-2458-12-740.

Additional files

Editorial Notes