Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
16/11/2009
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 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 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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

http://www.mcmaster.ca/

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

Results - basic reporting

Publication summary

2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11597669

Publication citations

  1. 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.

Additional files

Editorial Notes