Pilot study to assess the feasibility of running a randomised controlled trial to evaluate the effectiveness of physical activity promotion in general practice in increasing levels of exercise and reducing mental health problems among adolescents
| ISRCTN | ISRCTN18871417 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18871417 |
| Protocol serial number | N0096112100 |
| Sponsor | Department of Health (UK) |
| Funder | HertNet / CRIPACC (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 27/09/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Fiona Brooks
Scientific
Scientific
CRIPACC
University of Hertfordshire
Hatfield, Herts
AL10 9AB
United Kingdom
| Phone | +44 (0)1707 285992 |
|---|---|
| f.m.brooks@herts.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Pilot to assess the feasibility of running a large-scale trial to evaluate the effectiveness of nurse-led consultations in promoting adolescent physical activity. |
| Ethics approval(s) | Ethics approval was received from the local medical ethics committee before trial recruitment began. |
| Health condition(s) or problem(s) studied | Mental and Behavioural Disorders |
| Intervention | Teenagers will be invited to complete questionnaires about their exercise and other health related behaviours. Those who report that they do not exercise regularly will be randomised to one of two groups. The intervention group will be invited to a consultation with their practice nurse to discuss exercise and related lifestyle. The nurse will record physical health measures and encourage the teenager to develop a detailed written plan to achieve self-selected physical activity goals. Vouchers will be provided to encourage increased use of local sports centres. The nurse will also provide telephone support. Control teenagers will receive usual care. After 4 months both intervention and control group teenagers will be invited to complete a follow-up questionnaire and attend a brief health-check with their practice nurse. Non-attenders will be sent a final follow-up questionnaire at home. Added 5 September 2008: trial stopped due to poor recruitment. |
| Intervention type | Other |
| Primary outcome measure(s) |
Group comparison in terms of: |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 17 Years |
| Sex | Not Specified |
| Target sample size at registration | 1400 |
| Key inclusion criteria | Patients aged 13-17, 1400 in total registered at three general practices in Hertfordshire. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 31/10/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
CRIPACC
Hatfield, Herts
AL10 9AB
United Kingdom
AL10 9AB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
