Recovery through healthy living in acute psychiatric setting

ISRCTN	ISRCTN37185489
DOI	https://doi.org/10.1186/ISRCTN37185489
Secondary identifying numbers	5834

Submission date: 31/03/2010
Registration date: 31/03/2010
Last edited: 26/07/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

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

Ms Anca Alba
Scientific

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

Study information

Study design	Non-randomised multicentre interventional treatment trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Pilot study to enhance recovery through physical activity and healthy lifestyles in an acute psychiatric day hospital setting
Study objectives	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(s)	Warwickshire Research Ethics Committee, 26/02/2009, ref: 09/H1211/2
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2009
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 100
Key inclusion criteria	1. Individuals aged 18 - 65 years (either sex) 2. Diagnosis of schizophrenia, bipolar disorder, depression, anxiety disorder (including OCD) or personality disorder
Key exclusion criteria	1. Serious cardiovascular pathology 2. Uncontrolled hypertension 3. Liver disease 4. Renal failure
Date of first enrolment	01/01/2009
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Warwick Medical School

Coventry
CV4 7AL
United Kingdom

Sponsor information

University of Warwick (UK)
University/education

Gibbet Hill Road
Coventry
CV4 7AL
England
United Kingdom

Email	P.A.Hedges@warwick.ac.uk
Website	http://www2.warwick.ac.uk/
"ROR"	https://ror.org/01a77tt86

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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