Study of Health Assessment and Risk Evaluation in Aboriginal Peoples Action Toward Obesity Preven… (NCT00334269) | Clinical Trial Compass
CompletedNot Applicable
Study of Health Assessment and Risk Evaluation in Aboriginal Peoples Action Toward Obesity Prevention (SHARE-AP Action)
Canada174 participantsStarted 2004-05
Plain-language summary
The purpose of this study is to develop an effective intervention strategy to prevent \& reduce obesity among a high risk cohort of Aboriginal families.
Who can participate
Age range
5 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Eligible households are defined as those comprised of a male and female parent with at least one child \< 19 years old living in the same household
* Individuals between 5 and 65 years of age (including grandparents) are included
* Families must be living on Six Nations Indian Reserve, Ontario, Canada
Exclusion Criteria:
* Are not willing to have the SHARE-AP ACTION Health Counsellor visit their home on a weekly basis,
* Have a planned absence from the Reservation for \> 1 month during the intervention, and
* if there is a planned break-up of the household in the next 1 year
Individual members will be excluded from the household unit if they have:
* A serious medical illness which prevent them from making dietary and exercise changes (e.g.dialysis dependent),
* Terminal cancer,
* Suspected severe alcohol abuse, or
* have suffered a recent MI or stroke in the past month.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary outcomes of the pilot study include the change from baseline in daily energy intake (kcal per day), and the change in physical activity (minutes/week).