Condition category
Not Applicable
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
04/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joy Townsend

ORCID ID

Contact details

University of Hertfordshire
Centre for Research in Primary & Community Care
College Lane
Hatfield
AL10 9AB
United Kingdom
+44 (0)1707 285249

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Townsend RFG505 RCT

Study information

Scientific title

Acronym

Study hypothesis

The trial will evaluate the effectiveness of inviting teenagers for a primary care consultation with health behaviour advice and appropriate follow-up. The focus will be on Health of the Nation issues of depression, sexual health and smoking habits. There is evidence that intervening at this age may reduce immediate health problems related to depression and sexual transmitted disease, and reduce smoking levels thus reducing long term risks of chronic disease.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Health behaviour

Intervention

1. Usual care
2. Usual care plus primary care consultation with client-led health behaviour advice and follow-up

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. The level of risk behaviour at three and twelve months post intervention. Level of health behaviour for smoking, alcohol use, diet, exercise. Level of knowledge for drugs and sexual health (self reported by questionnaire, smoking will be validated by cotinine saliva samples)
2. Mental health at three months and twelve months (using Beck Depression Inventory)
3. Physical health at three months and twelve months (self reported by questionnaire)
4. Achievement of health behaviour goals set by teenager at the consultation for three and twelve months (self-addressed)

Secondary outcome measures

1. Teenagers' satisfaction with the consultations (questionnaire)
2. Appropriate use of services (questionnaire and medical records)

Overall trial start date

31/08/1998

Overall trial end date

31/12/2000

Reason abandoned

Eligibility

Participant inclusion criteria

Teenagers aged 14 and 15 years identified by the trial practices' age/sex registers within the six month recruitment period.

Participant type

Patient

Age group

Other

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

31/08/1998

Recruitment end date

31/12/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Hertfordshire
Hatfield
AL10 9AB
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Eastern (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