Randomised controlled trial to evaluate the effectiveness of inviting teenagers for a primary care consultation with health behaviour advice and follow-up care

ISRCTN	ISRCTN78288880
DOI	https://doi.org/10.1186/ISRCTN78288880
Protocol serial number	Townsend RFG505 RCT
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Eastern (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 04/02/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

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

Dr Joy Townsend
Scientific

University of Hertfordshire
Centre for Research in Primary & Community Care
College Lane
Hatfield
AL10 9AB
United Kingdom

Phone	+44 (0)1707 285249

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	1. Teenagers' satisfaction with the consultations (questionnaire) 2. Appropriate use of services (questionnaire and medical records)
Completion date	31/12/2000

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Not Specified
Key inclusion criteria	Teenagers aged 14 and 15 years identified by the trial practices' age/sex registers within the six month recruitment period.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	31/08/1998
Date of final enrolment	31/12/2000

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Hertfordshire

Hatfield
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