An attempt to improve physical and psychological health through study circles among persons with psychiatric disabilities
| ISRCTN | ISRCTN65503958 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65503958 |
| Secondary identifying numbers | VLL 1561:58-2004 |
- Submission date
- 28/08/2008
- Registration date
- 06/10/2008
- Last edited
- 03/07/2019
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Mikael Sandlund
Scientific
Scientific
Department of Clinical Sciences/Psychiatry
Umeå University
Umeå
SE-901 87
Sweden
| Phone | +46 90 786 50 00 |
|---|---|
| mikael.sandlund@vll.se |
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | A cluster randomised controlled life style intervention for persons with psychiatric disabilities |
| Study acronym | CRCLI |
| Study objectives | 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(s) | Regional Ethical Review Board at Umeå University. Date of approval: 11/01/2005 (ref: nr 04-177M) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 15/05/2005 |
| Completion date | 15/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 82 in total (41 staff members) |
| Total final enrolment | 82 |
| Key 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) |
| Key exclusion criteria | Those that did not accept to take part in the study. |
| Date of first enrolment | 15/05/2005 |
| Date of final enrolment | 15/05/2006 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Department of Clinical Sciences/Psychiatry
Umeå
SE-901 87
Sweden
SE-901 87
Sweden
Sponsor information
County Council of Västerbotten (Sweden)
Government
Government
Västerbotten läns Landsting
Umeå
901 89
Sweden
| Phone | +46 90 7857000 |
|---|---|
| landstingskontoret@vll.se | |
| Website | http://www.vll.se |
"ROR" |
https://ror.org/04xvhsp09 |
Funders
Funder type
Government
County Council of Västerbotten (Sweden)
No information available
The Vårdal Institute: The Swedish Institute for Health Sciences (Sweden)
No information available
The Swedish Council for Working Life and Social Research (FAS) (Sweden)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2008 | 03/07/2019 | Yes | No |
Editorial Notes
03/07/2019: Publication reference and total final enrolment added.
