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ObesityNCT00334269

Study of Health Assessment and Risk Evaluation in Aboriginal Peoples Action Toward Obesity Prevention (SHARE-AP Action)

A study testing Health messaging at weekly home visits by health counsellor, Weekly home delivery of bottled spring water and Weekly afterschool physical activity program for 5-18y.o. in people with Obesity, run by Population Health Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Health messaging at weekly home visits by health counsellor, Weekly home delivery of bottled spring water and Weekly afterschool physical activity program for 5-18y.o.
How many people
174 participants
Where
1 siteCanada
Study dates
May 2004to Dec 2005
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • SHARE-AP Office, Six Nations Health Services P.O. Box 5000

    Ohsweken, Ontario, N0A 1M0

Other trials in Canada

About this study

Official title: Study of Health Assessment and Risk Evaluation (SHARE) in Aboriginal Peoples (AP) Action Toward Obesity Prevention (SHARE-AP Action)

The purpose of this study is to develop an effective intervention strategy to prevent \& reduce obesity among a high risk cohort of Aboriginal families.

Read the detailed description

Obesity is a major public health problem in North America. The most recent estimates indicate that over 35% of men and 27% of women over the age of 18 are obese (body mass index (BMI) ≥30), and the prevalence of obesity among children and adolescents has increased over the last two decades to about 13%. Obesity leads to a number of chronic health problems including diabetes, hypertension, cardiovascular disease (CVD), and some cancers. Throughout the world, Aboriginal people suffer a high prevalence of overweight and obesity. This is likely due to their transition from a lifestyle of modest energy intake and high levels of physical activity, to a lifestyle of high energy intake and low levels of physical activity. This in turn has led to extraordinarily high rates of overweight, obesity, and type 2 diabetes.

There is an urgent need to test interventions to reduce or prevent obesity among Aboriginal people. Obesity has been resistant to traditional public health education strategies and novel approaches at multiple levels to develop effective strategies are required. SHARE-AP ACTION is a randomized controlled trial testing if a household-based intervention to improve change dietary and physical activity patterns has the potential to succeed where individual, school based and community interventions have not. Our project frees individuals from being alone in making subtle lifestyle changes, and uses the strength of the family unit to make changes toward healthy lifestyles. The family structure proposed in this project builds on the strengths of the family unit in Aboriginal culture, invokes role-modelling within the households and outside the household via the health counsellor, and facilitates opportunities to engage in regular group activities in a community where there is a paucity of physical activity.

This randomized controlled trial will test the feasibility of a culturally-sensitive household-based intervention, will determine the effect of the intervention on body weight, abdominal fat, blood pressure, glucose, and lipids, and will provide unique evaluation on intensive behavioural, and lifestyle modification program in a high-risk Aboriginal community.

Eligible families are randomized to intervention or control at baseline and are followed-up for 6-months. The intervention consists of: weekly home visits by trained health counsellors who provide information, advice and support on improving dietary habits and increasing physical activity; weekly home delivery of bottled water to supplant sugared drinks; and a variety of afterschool/work physical activity programs and nutritional workshops. Control families receive written material, including Canada's Food Guide to Healthy Eating and Canada's Physical Activity Guide to Healthy Active Living, which outlines suggestions for healthy living, and none of the interventions.

Conditions
Obesity
Being tested
Health messaging at weekly home visits by health counsellor, Weekly home delivery of bottled spring water, Weekly afterschool physical activity program for 5-18y.o., Cooking classes and grocery store tours with dietician, Pedometers to track/increase weekly physical activity
Keywords
obesity, physical activity, daily energy intake, nutrition, healthy lifestyle, Aboriginal, body fat, exercise, education, family, body mass index, knowledge, randomized controlled trial, community, intervention, Six Nations Indian Reserve, household, health counselling
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health messaging at weekly home visits by health counsellorBehavioural

  • Weekly home delivery of bottled spring waterBehavioural

  • Weekly afterschool physical activity program for 5-18y.o.Behavioural

  • Cooking classes and grocery store tours with dieticianBehavioural

  • Pedometers to track/increase weekly physical activityBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

Secondary outcomes (1)
  1. Secondary outcomes include the changes (from baseline to end of study) in knowledge and attitudes toward healthy lifestyles, self/response efficacy, body fat, BMI, abdominal fat, blood pressure, glucose, and lipids.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2006 (estimated)
  2. Study startMay 2004
  3. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
174 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00334269
Sponsor's protocol ID
MCT64076
Other IDs
ISRCTN86187625, CIHR Grant No. MCT64076, Final Protocol Nov.20, 2003
Status last verified
Sep 2009
First submitted
6 Jun 2006
Last updated
29 Sep 2009
Results posted
No

Publications

  • Anand SS, Yusuf S, Vuksan V, Devanesen S, Teo KK, Montague PA, Kelemen L, Yi C, Lonn E, Gerstein H, Hegele RA, McQueen M. Differences in risk factors, atherosclerosis, and cardiovascular disease between ethnic groups in Canada: the Study of Health Assessment and Risk in Ethnic groups (SHARE). Lancet. 2000 Jul 22;356(9226):279-84. doi: 10.1016/s0140-6736(00)02502-2.

    PubMed 11071182
  • Davis SM, Going SB, Helitzer DL, Teufel NI, Snyder P, Gittelsohn J, Metcalfe L, Arviso V, Evans M, Smyth M, Brice R, Altaha J. Pathways: a culturally appropriate obesity-prevention program for American Indian schoolchildren. Am J Clin Nutr. 1999 Apr;69(4 Suppl):796S-802S. doi: 10.1093/ajcn/69.4.796S.

    PubMed 10195605

Questions about this trial

What is this clinical trial studying?

A study testing Health messaging at weekly home visits by health counsellor, Weekly home delivery of bottled spring water and Weekly afterschool physical activity program for 5-18y.o. in people with Obesity, run by Population Health Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00334269, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2009.

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