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Investigation of the effectiveness and cost-effectiveness of the 'Girls Active' intervention

A cluster randomised controlled trial to investigate the effectiveness and cost-effectiveness of the 'Girls Active' intervention

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10688342
Enrollment
1600
Registered
2015-01-12
Start date
2015-02-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical activity Not Applicable

Interventions

This study will recruit 20 schools within Leicester, Leicestershire and Rutland. At each school a random sample of ~80 Key Stage 3 girls (aged 11-14 years) will be selected to take part in the evaluat

Sponsors

The University of Leicester
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: School inclusion criteria: 1. Government-funded secondary school within Leicester, Leicestershire and Rutland 2. Schools with at least 80 Key Stage 3 girls Pupil inclusion criteria: 1. Key Stage 3 girls (must be aged 11, 12, 13 or 14 years)

Exclusion criteria

Exclusion criteria: School exclusion criteria: 1. Private or independent schools and designated special needs schools 2. Schools that do not have any Key Stage 3 pupils Pupil exclusion criteria: 1. Girls outside of the targeted age range 2. Parent opt-out consent returned

Design outcomes

Primary

MeasureTime frame
A significant difference in mean minutes of moderate to vigorous activity between the intervention and the control group, measured by accelerometer at 14 months after baseline assessment.

Secondary

MeasureTime frame
1. A change in the following outcomes 7 and 14 months after baseline assessment: 1.1. Increase in objectively measured total volume of physical activity (accelerometer counts/days) 1.2. Increase in the proportion of girls meeting MVPA guidelines (objectively measured) 1.3. Increase in objectively measured MVPA at 7 months 1.4. Reduction in time spent sedentary (objectively measured and self-reported) 1.5. Reduction in measures of adiposity (body mass index, percentile, percent body fat) 1.6. Improvement in psychological factors that may mediate physical activity participation 2. A full cost effectiveness and cost-consequence analysis of the 'Girls Active' programme 3. A process evaluation of intervention implementation

Countries

England, United Kingdom

Contacts

Public ContactKyla Harrington
kyla.harrington@uhl-tr.nhs.uk+44 (0)1162584180

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026