SPRINT Study: active and smoke-free women
| ISRCTN | ISRCTN52660565 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52660565 |
| Secondary identifying numbers | TOSC1 |
- Submission date
- 27/01/2010
- Registration date
- 22/06/2010
- Last edited
- 08/05/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Elisabetta Chellini
Scientific
Scientific
Cancer Prevention and Research Institute
Unit of Environmental and Occupational Epidemiology
Via San Salvi, 12
Florence
50135
Italy
| e.chellini@ispo.toscana.it |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | SPRINT Study |
| Study objectives | 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(s) | Ethics Committee of the Local Health Authority of Florence, Italy, approved on the 5th May 2009 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2009 |
| Completion date | 30/11/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1,350 smoking women |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 30/11/2011 |
Locations
Countries of recruitment
- Italy
Study participating centre
Cancer Prevention and Research Institute
Florence
50135
Italy
50135
Italy
Sponsor information
Ministry of Health, Rome (Italy)
Government
Government
Viale Giorgio Ribotta 5
Rome
00144
Italy
| m.distefano@sanita.it | |
| Website | http://www.ministerosalute.it/index.jsp |
"ROR" |
https://ror.org/00789fa95 |
Funders
Funder type
Government
Ministry of Health, Rome (Italy) - Lombardy Region
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/09/2012 | Yes | No |
