Contact information
Type
Scientific
Primary contact
Dr Liselotte Schäfer Elinder
ORCID ID
Contact details
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
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HSN 0802-0339
Study information
Scientific title
Health promotion in community residences for people with intellectual disabilities: A randomised controlled trial
Acronym
Study hypothesis
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
The study was approved by the Regional Ethical Review Board in Stockholm on the 17th of September 2009 (ref: 2009/1332)
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/08/2009
Overall trial end date
31/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
Participant exclusion criteria
1. Community residences for adult people with severe intellectual disabilities
2. People with intellectual disabilities living on their own
Recruitment start date
01/08/2009
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Sweden
Trial participating centre
Karolinska Institutet
Stockholm
104 62
Sweden
Sponsor information
Organisation
Health Care Board and Management (Hälso- och sjukvårdsnämndens förvaltning) (Sweden)
Sponsor details
Folkhälsoanslaget
Box 6909
Stockholm
102 39
Sweden
cecilia.lindvall@sll.se
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Stockholm County Council (Folkhälsoanslaget) (Sweden)
Alternative name(s)
Stockholm County Council
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Sweden
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
Basic results (scientific)
Publication list
1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21144033
Publication citations
-
Protocol
Elinder LS, Bergström H, Hagberg J, Wihlman U, Hagströmer M, Promoting a healthy diet and physical activity in adults with intellectual disabilities living in community residences: design and evaluation of a cluster-randomized intervention., BMC Public Health, 2010, 10, 761, doi: 10.1186/1471-2458-10-761.