Condition category
Mental and Behavioural Disorders
Date applied
28/08/2008
Date assigned
06/10/2008
Last edited
06/10/2008
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

Prof Mikael Sandlund

ORCID ID

Contact details

Department of Clinical Sciences/Psychiatry
Umeå University
Umeå
SE-901 87
Sweden
+46 90 786 50 00
mikael.sandlund@vll.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

VLL 1561:58-2004

Study information

Scientific title

A cluster randomised controlled life style intervention for persons with psychiatric disabilities

Acronym

CRCLI

Study hypothesis

Risk factors for somatic diseases as well as indicators for quality of life and sense of coherence will significantly change in a positive direction as a result of the intervention as compared to controls.

Ethics approval

Regional Ethical Review Board at Umeå University. Date of approval: 11/01/2005 (ref: nr 04-177M)

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Psychiatric disability and co-morbidity

Intervention

The age range of the participants was 23-71 years.

The intervention groups were offered a programme for healthy living in a form of a study circle developed by the Workers Educational Association (ABF). The study material has been used for the general population as well as for groups of persons with functional impairments. Each intervention group circle comprised of 5 to 12 residents and staff members with the same leader. Each study circle met twice a week for two hours for the duration of the 12 month programme; one session focused on the cooking of good nourishing food and the other on physical activity. The sessions took place in the staff flat, where most of the cooking was carried out. A balanced diet chart, the importance of main meals and snacks, fruits, vitamins, diet fibres, sugar and fat were topics for the discussions. The lessons were mainly practical with a short theoretical content. While buying ingredients, baking bread or preparing a meal, the members were encouraged to read and discuss the declaration of contents of the various foodstuffs and how to make healthy and economical choices. The lessons required an active participation in activities regarding planning, food preparation and washing up the dishes.

The physical activity sessions gave the participants the opportunity to try various types of sports and training. There was a mixture of fitness training, team games, individual games and open-air activities for example walks, badminton, bowling, table tennis, indoor bandy, swimming, working-out, bicycle excursions, jig fishing, and gathering mushrooms. These sessions also contained a short theoretical content such as the nature of the human body and the necessity to be active to maintain its functions, avoiding injuries related to training, motivation, goals, but also information about tobacco, alcohol and drugs. The staff participated in all activities on basically the same conditions as the residents, doing the same tests, answering the same questionnaires and participating in the study circle, but at the same time supporting the leader and the residents.

The participants in the control groups were offered an aesthetic study circle in five groups entitled "Colour and Shape". The number of residents and staff varied between five and nine and they met once a week for two hours mainly at the staff flat, where some of the activities took place. The participants had the opportunity to learn and practice various kinds of artistic techniques e.g., sketching, charcoal drawing, pencil drawing, oils, batik and collage. The access to a pottery gave the opportunity to try different techniques with clay and the participants also went to art exhibitions and were encouraged to look at art and discuss it. Total duration of the aesthetic study programme: 12 month.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The following will be assessed at baseline and follow-up after 12 month of intervention:
1. Changes in HeartScore®
2. Body mass index (BMI)
3. Criteria for metabolic syndrome: Hba1c, P-gluc, P-ins, lipids, heart rate, blood pressure, weight, height, waist circumference, incremental shuttle walking test (ISWT)
4. Sense of Coherence Scale (SOC)
5. Global Assessment of Functioning Scale (GAFS)
6. Manchester Short Assessment of Quality of Life (MANSA)

Secondary outcome measures

The following will be assessed at baseline and follow-up after 12 month of intervention:
1. Changes in physical activity: the participants used a pedometer SILVA™ Pedometer Plus attached to their hip ten hours per day (between 9 am to 7 pm) during one week at baseline and follow-up.
2. Symptom Checklist-90-R (SCL-90-R)
3. 36-item Short Form Health Survey (SF-36)

Overall trial start date

15/05/2005

Overall trial end date

15/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females
2. Persons with psychiatric disabilities (diagnoses of schizophrenia, bipolar disorder, severe personality disorders) recieving social support in supported housing facilities and their staff who consented to take part in the study
3. No age limit (However, the supported housing are available for persons with psychiatric disability over 18 years or older)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

82 in total (41 staff members)

Participant exclusion criteria

Those that did not accept to take part in the study.

Recruitment start date

15/05/2005

Recruitment end date

15/05/2006

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Clinical Sciences/Psychiatry
Umeå
SE-901 87
Sweden

Sponsor information

Organisation

County Council of Västerbotten (Sweden)

Sponsor details

Västerbotten läns Landsting
Umeå
901 89
Sweden
+46 90 7857000
landstingskontoret@vll.se

Sponsor type

Government

Website

http://www.vll.se

Funders

Funder type

Government

Funder name

County Council of Västerbotten (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Vårdal Institute: The Swedish Institute for Health Sciences (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Swedish Council for Working Life and Social Research (FAS) (Sweden)

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