|
ISRCTN
|
ISRCTN86187625
|
|
ClinicalTrials.gov identifier
|
NCT00334269
|
|
Public title
|
The study of health assessment and risk evaluation: Obesity Prevention (SHARE-OP)
|
|
Scientific title
|
|
|
Acronym
|
SHARE-OP
|
|
Serial number at source
|
MCT-64076
|
|
Study hypothesis
|
To develop an effective intervention strategy to prevent and reduce obesity among a high risk cohort of Aboriginal families.
|
|
Lay summary
|
|
|
Ethics approval
|
McMaster University Population Health Research Institute Research Ethics Board approved on the 23rd December 2003
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Canada
|
|
Disease/condition/study domain
|
Obesity
|
|
Participants - 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)
|
|
Participants - 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
|
|
Anticipated start date
|
01/10/2000
|
|
Anticipated end date
|
30/09/2005
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
50
|
|
Interventions
|
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 Canada’s Food Guide to Healthy Eating and Canada’s 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 Canada’s 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 household’s (control or intervention) nutrition or activity questions during working hours.
Trial details received: 07 Sept 2005
|
|
Primary outcome measure(s)
|
Change from baseline in daily energy intake (kcal per day), and the change in physical activity (minutes/week).
|
|
Secondary outcome measure(s)
|
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
|
|
Sources of funding
|
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-64076)
|
|
Trial website
|
|
|
Publications
|
2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11597669
|
|
Contact name
|
Dr
Sonia Savitri
Anand
|
|
Address
|
Hamilton General Hospital
McMaster Clinic, Rm. 522
237 Barton Street East
|
|
City/town
|
Hamilton
|
|
Zip/Postcode
|
L8L 2X2
|
|
Country
|
Canada
|
|
Tel
|
+1 905 527 4322 ext. 44557
|
|
Fax
|
+1 905 577 1490
|
|
Email
|
anands@mcmaster.ca
|
|
Sponsor
|
McMaster University (Canada)
|
|
Address
|
Office of the Associate Dean Research
Faculty of Health Sciences
1200 Main St. W., Room HSC-3N8
|
|
City/town
|
Hamilton
|
|
Zip/Postcode
|
L8N 3Z5
|
|
Country
|
Canada
|
|
Tel
|
+1 905 525 9140 ext. 22465
|
|
Fax
|
+1 905 528 8539
|
|
Email
|
hsresadm@mcmaster.ca
|
|
Sponsor website:
|
http://www.mcmaster.ca/
|
|
Date applied
|
26/09/2005
|
|
Last edited
|
16/11/2009
|
|
Date ISRCTN assigned
|
26/09/2005
|
