Details on the design of the SPRINT study, a three-arm randomized controlled trial, have been already published [15
], and are briefly summarized here. The study recruited 1,100 smoking women aged 25–64 years attending CCSP consulting rooms: 215 in Florence, 489 in Turin, and 396 in Mantua. Then, 363, 366, and 371 participants were randomly assigned to smoking cessation counselling [SC] arm, the smoking cessation+PA counselling [SC+PA] arm, or to the control arm, respectively (Figure
Flow chart of the enrolment of women attending the National Cervical Cancer Screening Programme in Florence, Turin, and Mantua.
Women waiting to perform the test were asked to fill in the study questionnaire and participants provided informed consent. Questionnaire regarded demographic characteristics, lifetime and current use of cigarettes, frequency of previous quit attempts, the Fagerström Tolerance Questionnaire (FTQ) [17
], intention to quit to assess the Di Clemente-Prochaska stage of change for smoking cessation (precontemplation, contemplation, preparation) [12
]. Moreover, 5 stages were distinguished in the questionnaire, following the Di Clemente-Prochaska stages of change for increasing PA (precontemplation, contemplation, preparation, action, or maintenance) [11
]. Women who decided to participate handed in the filled questionnaires to the midwives before the Pap-test examination.
A self-help booklet on smoking cessation and increasing PA was provided to all study participants.
Counselling was delivered after the Pap test examination by the same midwives who performed the test. Midwives were trained to deliver counselling for smoking cessation and for increasing PA.
The smoking cessation counselling corresponds to the first two phases of the brief intervention for smoking cessation (“Ask” and “Advice”) [7
]. It was tailored according to the Di Clemente-Prochaska stage of change on smoking cessation [12
]. If participants were in the precontemplation stage of change for smoking cessation, e.g., women did not even consider quitting, and were randomized to both the SC or the SC
PA arms, midwives’ goal was to move them toward contemplation, and to help women think about quitting. If women were in the contemplation stage of change, e.g., they were thinking of quitting in the next 6 months, midwives’ goal was to tilt the balance toward cessation, and to encourage women to move towards quitting soon. If women were in the preparation stage, i.e., were planning to quit in the next month, midwives’ goal was to motivate to quit, and to help setting a quit-day.
The PA counselling was a brief intervention, designed and validated by psychologists involved in the study [13
]. It was a stage-specific counselling, according to the Di Clemente-Prochaska stage assessment on PA [18
]. If participants were in the precontemplation stage of change for increasing PA, and were randomized to the SC
PA arm, midwives’ goal was to move them towards contemplation. If women were in the contemplation stage of change for increasing PA, midwives’ goal was to remove their ambivalence on increasing PA. If women were in the preparation stage of change, midwives’ goal was to identify barriers to do more physical exercise. Finally, if women were in the action or maintenance stages of change, e.g., they had begun to do more physical exercise in the last 6 months or for more than 6 months, respectively, midwives reinforced reasons for increasing PA.
A telephone follow-up was scheduled after six months from the intervention, in order to know how many women successfully quitted, and, among those who did not quit, how many improved their motivational stage of change for smoking cessation (e.g., from precontemplation before the intervention to contemplation or preparation after the intervention; from contemplation before the intervention to preparation afterwards), and how many reduced the number of cigarettes smoked per day. Moreover, PA levels after the intervention were assessed during the follow-up interview.
The SPRINT Study was submitted and approved by the Ethics Committee of the Local Health Authority of Florence, Italy (authorization n.143/2009). This trial study is registered, number ISRCTN52660565.
Three main outcomes were analyzed: quitting smoking, improving the motivational stage of change for smoking cessation, and reducing the number of cigarettes per day. Additionally, we analyzed PA outcomes (percentage of women engaged in moderate/intense PA for at least 30 minutes on at least 5 days per week; improvement of their stage of change for increasing PA).
In order to take into account the hierarchical structure of the data, estimates of the intervention effect at six-month follow-up for all centers were obtained with random effects logistic regression models with centre as a random effect, and including age as covariate. The model was not adjusted for baseline characteristics because there were no significant differences among groups at baseline [15
]. Analysis was by intention to treat. The software STATA 11 was used for the analyses.