Contact information
Type
Scientific
Primary contact
Dr Sonia Savitri Anand
ORCID ID
Contact details
Hamilton General Hospital
McMaster Clinic
Rm. 522
237 Barton Street East
Hamilton
L8L 2X2
Canada
+1 905 527 4322 ext. 44557
anands@mcmaster.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00334269
Protocol/serial number
MCT-64076
Study information
Scientific title
Acronym
SHARE-OP
Study hypothesis
To develop an effective intervention strategy to prevent and reduce obesity among a high risk cohort of Aboriginal families.
Ethics approval
McMaster University Population Health Research Institute Research Ethics Board approved on the 23rd December 2003
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Condition
Obesity
Intervention
Intervention: Family based behavioural, dietary and physical activity lifestyles modification program of six months duration. Provision of goods: a water cooler, grocery and water.
Control: Families randomised to control:
1. Attend a 30-minute introductory session with our health counsellors
2. Are provided with written material, including Canadas Food Guide to Healthy Eating and Canadas Physical Activity Guide to Healthy Active Living, which outline suggestions for healthy living
3. After the baseline health assessment, control households receive their body mass index (BMI) and waist to hip measurements, and the Health Canadas Healthy Weight Chart. However, no specific individualised program is offered as with intervention families.
4. The after-school physical activity program is also open to school-aged children from control households in order to minimize the sentiment that children in intervention households have received superior opportunities compared to control households
5. We also have a help phone line to answer any households (control or intervention) nutrition or activity questions during working hours.
Trial details received: 07 Sept 2005
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Change from baseline in daily energy intake (kcal per day), and the change in physical activity (minutes/week).
Secondary outcome measures
1. Blood pressure
2. BMI
3. HbA1c
4. Body fat
5. Changes (from baseline to end of study) in knowledge and attitudes toward healthy lifestyles
Overall trial start date
01/10/2000
Overall trial end date
30/09/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Households comprised of a male and female parent with at least one child living in the same household
2. Individuals between 5 and 65 years of age (including grandparents)
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Households who are not willing to have the SHARE-OP health counselor visit their home on weekly basis
2. Have planned absence from the reservation for greater than 1 month during the intervention
3. If there is a planned break-up of the household in the next one year
4. Individual members with serious medical illness, which prevents them from making dietary and exercise changes
5. Terminal cancer
6. Suspected severe alcohol abuse
7. Have suffered a recent myocardial infarction (MI) or stroke in the past month
Recruitment start date
01/10/2000
Recruitment end date
30/09/2005
Locations
Countries of recruitment
Canada
Trial participating centre
Hamilton General Hospital
Hamilton
L8L 2X2
Canada
Sponsor information
Organisation
McMaster University (Canada)
Sponsor details
Office of the Associate Dean Research
Faculty of Health Sciences
1200 Main St. W.
Room HSC-3N8
Hamilton
L8N 3Z5
Canada
+1 905 525 9140 ext. 22465
hsresadm@mcmaster.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-64076)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11597669
Publication citations
-
Results
Anand SS, Yusuf S, Jacobs R, Davis AD, Yi Q, Gerstein H, Montague PA, Lonn E, Risk factors, atherosclerosis, and cardiovascular disease among Aboriginal people in Canada: the Study of Health Assessment and Risk Evaluation in Aboriginal Peoples (SHARE-AP)., Lancet, 2001, 358, 9288, 1147-1153.