The study of health assessment and risk evaluation: Obesity Prevention (SHARE-OP)
| ISRCTN | ISRCTN86187625 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86187625 |
| ClinicalTrials.gov number | NCT00334269 |
| Secondary identifying numbers | MCT-64076 |
- Submission date
- 26/09/2005
- Registration date
- 26/09/2005
- Last edited
- 16/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sonia Savitri Anand
Scientific
Scientific
Hamilton General Hospital
McMaster Clinic, Rm. 522
237 Barton Street East
Hamilton
L8L 2X2
Canada
| Phone | +1 905 527 4322 ext. 44557 |
|---|---|
| anands@mcmaster.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Scientific title | |
| Study acronym | SHARE-OP |
| Study objectives | To develop an effective intervention strategy to prevent and reduce obesity among a high risk cohort of Aboriginal families. |
| Ethics approval(s) | McMaster University Population Health Research Institute Research Ethics Board approved on the 23rd December 2003 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2000 |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 50 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/10/2000 |
| Date of final enrolment | 30/09/2005 |
Locations
Countries of recruitment
- Canada
Study participating centre
Hamilton General Hospital
Hamilton
L8L 2X2
Canada
L8L 2X2
Canada
Sponsor information
McMaster University (Canada)
University/education
University/education
Office of the Associate Dean Research
Faculty of Health Sciences
1200 Main St. W., Room HSC-3N8
Hamilton
L8N 3Z5
Canada
| Phone | +1 905 525 9140 ext. 22465 |
|---|---|
| hsresadm@mcmaster.ca | |
| Website | http://www.mcmaster.ca/ |
"ROR" |
https://ror.org/02fa3aq29 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-64076)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/10/2001 | Yes | No |
