Condition category
Mental and Behavioural Disorders
Date applied
31/03/2010
Date assigned
31/03/2010
Last edited
26/07/2016
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

Ms Anca Alba

ORCID ID

Contact details

Health Sciences Research Institute
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5834

Study information

Scientific title

Pilot study to enhance recovery through physical activity and healthy lifestyles in an acute psychiatric day hospital setting

Acronym

Study hypothesis

Individuals with serious mental disorders die up to 30 years earlier than the general population, mostly from cardiovascular causes. Explanations include obesity, diabetes, hypertension, smoking, poor diet and sedentary lifestyle. Diabetes is three times more common in schizophrenia than in the general population, and twice as common in depression. Despite calls for urgent action, services to address this problem are rare. This is partly due to the dearth of evidence to guide implementation.

Trials in diabetes and hypertension show that that increasing physical activity can be effective and sustainable, but this requires motivational support. There have been a few lifestyle change interventions among people with serious mental illness, but none has been fully evaluated to date. If effective, acceptable and sustainable, an intervention that improved the physical health of people with serious mental illness could transform the prognosis of these disorders. The payoffs in increased life expectancy and improved quality of life are enormous.

The proposed study aims to develop and extend a newly established healthy living initiative designed to improve the physical health of individuals with serious mental illness, in preparation for a Phase III trial.

Ethics approval

Warwickshire Research Ethics Committee, 26/02/2009, ref: 09/H1211/2

Study design

Non-randomised multicentre interventional treatment trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Mental Health Research Network; Subtopic: All Diagnoses; Disease: Not Applicable

Intervention

All service users will be invited to participate in the study on admission and those who agree and consent will undergo a physical health and lifestyle assessment. In addition to cardiovascular and metabolic risk factors, general fitness and any musculoskeletal problems will be assessed by the project Physiotherapist. The latter will also be responsible for completing individually-tailored Healthy Lifestyle care plans addressing physical activity, weight, diet and smoking as soon as practicable after admission. Each participant will be given (and allowed to keep) an inexpensive pedometer to encourage self-monitoring of physical activity. Participants will be offered regular, individual monthly review of these lifestyle care plans, and this will be reinforced in weekly meetings with key workers and at fortnightly multidisciplinary clinical review meetings. Caroline Morgan, a senior RMN at Willow View, initiated the service and continues to oversee its delivery. She will continue to coordinate and champion the Healthy Lifestyles Programme within the Day Hospital with support from the project Physiotherapist.

As part of lifestyle care plans, participants will be encouraged to take part in a range of activities, according to physical and mental health and personal preferences. Most activities take place off-site, typically within local authority leisure facilities. Participation in activities outside of mental health settings reduces perceived stigma, increases the range of available activities and encourages maintenance beyond discharge from Willow View. Attendees can choose from aerobic step class, circuit training, swimming, badminton, cycling, individual or group walking, and yoga. We will also look to increase the range of activity options - like 5-a-side football, gardening clubs and Tai Chi - in collaboration with other stakeholders. Widening the repertoire of available activities through local partnerships will be a key role of the project Physiotherapist. Where appropriate, staff will accompany individuals or groups of service users to encourage participation.

Healthy lifestyle group:
All service users at Willow View are encouraged to attend a weekly Healthy Lifestyles group. This open group meets for 1.5 hours each week, with a rolling programme covering all aspects of lifestyle such as diet (including budgeting, cooking and daily fruit and vegetable consumption, weight and reasons for and alternatives to overeating. Once every 6 - 8 weeks an outside speaker attends, including a community dietician, a smoking cessation counsellor, and colleagues from the community alcohol service. Regular physical activity is strongly encouraged, with timetabled sessions for this. This integrated 'healthy lifestyle' ethos permeates the service; for example, the budgeting and cooking skills group designed to enhance skills of daily living reinforces the health eating message.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Height, weight, body mass index (BMI), and central (visceral) obesity using waist circumference, measured at baseline, 3 months and 6 months follow-up.

Secondary outcome measures

Clinical and functional outcomes will be assessed using the Core Assessment and Outcomes Package, measured at baseline, 3 months and 6 months follow-up.

Overall trial start date

01/01/2009

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Individuals aged 18 - 65 years (either sex)
2. Diagnosis of schizophrenia, bipolar disorder, depression, anxiety disorder (including OCD) or personality disorder

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 100

Participant exclusion criteria

1. Serious cardiovascular pathology
2. Uncontrolled hypertension
3. Liver disease
4. Renal failure

Recruitment start date

01/01/2009

Recruitment end date

31/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Warwick Medical School
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
-
P.A.Hedges@warwick.ac.uk

Sponsor type

University/education

Website

http://www2.warwick.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

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

26/07/2016: No publications found, verifying study status with principal investigator.