Health promotion in community residences
| ISRCTN | ISRCTN33749876 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33749876 |
| Secondary identifying numbers | HSN 0802-0339 |
- Submission date
- 24/05/2010
- Registration date
- 30/06/2010
- Last edited
- 30/03/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
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
Dr Liselotte Schäfer Elinder
Scientific
Scientific
Karolinska Institutet
Department of Public Health Sciences
Division of intervention and implementation research
Box 170 70
Stockholm
104 62
Sweden
| liselotte.schafer-elinder@ki.se |
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Health promotion in community residences for people with intellectual disabilities: A randomised controlled trial |
| Study objectives | The overall aim is to develop and evaluate the effects of a health education programme directed at both staff and residents in community residences for people with intellectual disabilities. Specific objectives are to study improvements in work routines and environment and to study individual effects on dietary and physical activity habits, BMI, waist circumference and quality of life due to the intervention. |
| Ethics approval(s) | The study was approved by the Regional Ethical Review Board in Stockholm on the 17th of September 2009 (ref: 2009/1332) |
| Health condition(s) or problem(s) studied | Prevention of obesity and chronic diseases related to diet and physical activity among adult people with intellectual disabilities |
| Intervention | 32 community residences are selected in Stockholm county and randomised to intervention (n=16) and control (n=16) residences. The intervention group takes part in a health programme including three main components, which will be implemented during 12 months: 1. A health education activity including diet and physical activity targeting residents in community residences. The activity consists of ten sessions which will be carried out in the residences by an external educator. 2. A health ambassador will be appointed among staff members in each residence. The health ambassador will be responsible for health issues and will receive coaching by the project team. 3. The staff in every community residence will come together in 10 sessions to discuss health issues. A discussion leader will be appointed and the group will meet to discuss ten different themes on the basis of a programme material developed specifically for this project. |
| Intervention type | Other |
| Primary outcome measure | Physical activity will be assessed by pedometry for seven consecutive days. The data will be collected before and after intervention. Parametric and non-parametric tests will be used to compare groups at baseline. Multilevel analysis will be used to evaluate the effects of the intervention outcomes. Two levels are defined in the analysis: 1. resident 2. residential setting Linear and logistic regression models will be used to study the effects on the outcome variables. |
| Secondary outcome measures | 1. BMI and waist circumference will be measured by the research team 2. Dietary habits will be assessed by use of digital photography taken by residents for three days 3. Quality of life will be assessed by a structured interview The analysis will be carried out as for the primary outcome. |
| Overall study start date | 01/08/2009 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 160 |
| Key inclusion criteria | Community residences for adult people with mild or moderate intellectual disabilities, in Stockholm County. A minimum of three residents in each residence who agree to participate. |
| Key exclusion criteria | 1. Community residences for adult people with severe intellectual disabilities 2. People with intellectual disabilities living on their own |
| Date of first enrolment | 01/08/2009 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Karolinska Institutet
Stockholm
104 62
Sweden
104 62
Sweden
Sponsor information
Health Care Board and Management (Hälso- och sjukvårdsnämndens förvaltning) (Sweden)
Government
Government
Folkhälsoanslaget
Box 6909
Stockholm
102 39
Sweden
| cecilia.lindvall@sll.se | |
"ROR" |
https://ror.org/04d5f4w73 |
Funders
Funder type
Government
Stockholm County Council (Folkhälsoanslaget) (Sweden)
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- Stockholm County Council
- Location
- Sweden
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/12/2010 | Yes | No |
