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
Secondary identifying numbers	N0096112100

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

CRIPACC
University of Hertfordshire
Hatfield, Herts
AL10 9AB
United Kingdom

Phone	+44 (0)1707 285992
Email	f.m.brooks@herts.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
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	Group comparison in terms of: 1. Frequency of exercise 2. Stage of change for exercise 3. Change in mental health scores (CES-DC) 4. Physical health measures (body mass index [BMI], peak flow, blood pressure)
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/08/2002
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 number of participants	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

England
United Kingdom

Study participating centre

CRIPACC

Hatfield, Herts
AL10 9AB
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

HertNet / CRIPACC (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan