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
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