A cluster randomised controlled trial to investigate the effectiveness and cost effectiveness of the 'Girls Active' intervention: a study protocol

Background: Despite the health benefits of physical activity, data from the UK suggest that a large proportion of adolescents do not meet the recommended levels of moderate-to-vigorous physical activity (MVPA). This is particularly evident in girls, who are less active than boys across all ages and may display a faster rate of decline in physical activity throughout adolescence. The ‘Girls Active’ intervention has been designed by the Youth Sport Trust to target the lower participation rates observed in adolescent girls. ‘Girls Active’ uses peer leadership and marketing to empower girls to influence decision making in their school, develop as role models and promote physical activity to other girls. Schools are provided with training and resources to review their physical activity, sport and PE provision, culture and practices to ensure they are relevant and attractive to adolescent girls. Methods/Design: This study is a two-arm cluster randomised controlled trial (RCT) aiming to recruit 20 secondary schools. Clusters will be randomised at the school level (stratified by school size and proportion of Black and Minority Ethnic (BME) pupils) to receive either the ‘Girls Active’ intervention or carry on with usual practice (1:1). The 20 secondary schools will be recruited from state secondary schools within the Midlands area. We aim to recruit 80 girls aged 11 –14 years in each school. Data will be collected at three time points; baseline and seven and 14 months after baseline. Our primary aim is to investigate whether ‘Girls Active’ leads to higher objectively measured (GENEActiv) moderate-to-vigorous physical activity in adolescent girls at 14 months after baseline assessment compared to the control group. Secondary outcomes include other objectively measured physical activity variables, adiposity, physical activity-related psychological factors and the cost-effectiveness of the ‘Girls Active’ intervention. A thorough process evaluation will be conducted during the course of the intervention delivery. Discussion: The findings of this study will provide valuable information on whether this type of school-based approach to increasing physical activity in adolescent girls is both effective and cost-effective in the U

Reasons for losses between referral and randomisation.

<p>Reasons for losses between referral and randomisation.</p

Summary of health and social service costs to the intervention and control groups over 10 months.

<p>Summary of health and social service costs to the intervention and control groups over 10 months.</p

Summary of results of the cost-utility analysis.

<p>Summary of results of the cost-utility analysis.</p

Consort diagram of participant flow through study.

<p>Consort diagram of participant flow through study.</p

Baseline characteristics of people with dementia and carers—mean (sd).

<p>Baseline characteristics of people with dementia and carers—mean (sd).</p

Primary and secondary end point results adjusted analysis models for person with dementia measures. Adjusted for participant age, baseline outcome score, centre, participant gender, relationship (spousal/non-spousal).

<p>Primary and secondary end point results adjusted analysis models for person with dementia measures. Adjusted for participant age, baseline outcome score, centre, participant gender, relationship (spousal/non-spousal).</p

Summary of results of the cost-effectiveness analysis for participants with dementia using QoL-AD as a measure of effectiveness.

<p>Summary of results of the cost-effectiveness analysis for participants with dementia using QoL-AD as a measure of effectiveness.</p

Base case costs for Remembering Yesterday Caring Today (RYCT) programme of 12 weekly joint reminiscence groups and 7 monthly maintenance sessions based on data from 19 waves of recruitment.

<p>Base case costs for Remembering Yesterday Caring Today (RYCT) programme of 12 weekly joint reminiscence groups and 7 monthly maintenance sessions based on data from 19 waves of recruitment.</p

Primary and secondary end point results adjusted analysis models for carer measures. Adjusted for carer age, baseline outcome score, centre, carer gender, relationship (spousal/non-spousal).

<p>Primary and secondary end point results adjusted analysis models for carer measures. Adjusted for carer age, baseline outcome score, centre, carer gender, relationship (spousal/non-spousal).</p