Study protocol: A cluster randomised controlled trial of implementation intentions to reduce smoking initiation in adolescents

Abstract

Background: The current literature suggests that forming implementation intentions (simple 'if-then' plans) about how to refuse the offer of a cigarette may be an effective intervention to reduce smoking initiation in adolescents. This study is a pragmatic trial to test the effectiveness and cost-effectiveness of such an intervention in reducing smoking initiation in a sample of UK adolescents.

Methods/design: A cluster randomised controlled trial with at least 36 schools randomised to receive an implementation intention intervention targeting reducing smoking initiation (intervention group) or increasing homework (control group). Interventions will be conducted at the classroom level and be repeated every six months for four years (eight interventions). Objectively assessed (carbon monoxide monitor) and self-reported smoking plus smoking related cognitions (e.g., smoking intentions, attitudes, norms and self-efficacy) will be assessed at baseline and 12, 24, 36 and 48 months post baseline. Objectively assessed smoking at 48 months post baseline will be the primary outcome variable. Health economic analyses will assess life years gained.

Discussion: The results of the trial will provide information on the impact of a repeated implementation intention for refusing offers of cigarettes on rates of smoking initiation in adolescents.

Trial registration: ISRCTN27596806.

Figure 1

Flow Chart of Study Procedures for both Groups.

Figure 2

Randomization flow chart.