Condition category
Mental and Behavioural Disorders
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
27/06/2011
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 Archibald Stephen Brown

ORCID ID

Contact details

Cannon House
Cannon Street
Shirley
Southampton
SO15 5PQ
United Kingdom
+44
steve.brown@wht.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0230176071

Study information

Scientific title

Acronym

Study hypothesis

Can a specific programme of health promotion interviews, delivered by their key worker, to clients with serious mental illness produce meaningful health gains?

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Mental and Behavioural Disorders

Intervention

Subjects will be randomised using a hidden computer generated random number programme to receive five sessions of supervised health promotion interventions in addition to their usual treatment or to receive treatment as usual from their key worker. Subjects randomised to the 'treatment as usual' group will be offered the health promotion interventions at the end of the study period. The initial measurements will be repeated after 5 sessions of health education (subjects) or 10 weeks of treatment as usual (controls). Pre and post intervention measurements will be made by the same rater who will be blind to the interviewees status in the study.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Basic health screening questionnaire and measure of height, weight, blood pressure and resting pulse. Baseline lifestyle factors (diet, exercise, smoking, alcohol and drug use) and psychological health will be measured using validated research instruments (the Hospital Anxiety and Depression (HAD) scale and SF-36 scale of subjective well being.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2006

Overall trial end date

31/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Key workers and patients of the West Southampton CMHT location of Hampshire Partnership Trust.

Participant type

Patient

Age group

Adult

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

01/02/2006

Recruitment end date

31/08/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cannon House
Southampton
SO15 5PQ
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

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.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

West Hampshire Consortium (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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

1. 2006 results in http://www.ingentaconnect.com/content/apl/cjmh/2006/00000015/00000005/art00005

Publication citations

Additional files

Editorial Notes