Condition category
Mental and Behavioural Disorders
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
27/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Fiona Brooks

ORCID ID

Contact details

CRIPACC
University of Hertfordshire
Hatfield
Herts
AL10 9AB
United Kingdom
+44 (0)1707 285992
f.m.brooks@herts.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0096112100

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval was received from the local medical ethics committee before trial recruitment began.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/08/2002

Overall trial end date

31/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged 13-17, 1400 in total registered at three general practices in Hertfordshire.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

1400

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/08/2002

Recruitment end date

31/10/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

CRIPACC
Hatfield, Herts
AL10 9AB
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

HertNet / CRIPACC (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes