Health promotion in community residences

ISRCTN	ISRCTN33749876
DOI	https://doi.org/10.1186/ISRCTN33749876
Protocol serial number	HSN 0802-0339
Sponsor	Health Care Board and Management (Hälso- och sjukvårdsnämndens förvaltning) (Sweden)
Funder	Stockholm County Council (Folkhälsoanslaget) (Sweden)

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

Karolinska Institutet
Department of Public Health Sciences
Division of intervention and implementation research
Box 170 70
Stockholm
104 62
Sweden

Email	liselotte.schafer-elinder@ki.se

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes