Condition category
Not Applicable
Date applied
24/05/2010
Date assigned
30/06/2010
Last edited
30/03/2011
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

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 measures

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

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

Results - basic reporting

Publication summary

1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21144033

Publication citations

  1. 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.

Additional files

Editorial Notes