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

September 27, 2009 updated by: Population Health Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ohsweken, Ontario, Canada, N0A 1M0
        • SHARE-AP Office, Six Nations Health Services P.O. Box 5000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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).

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Sonia S Anand, MD, PhD, Population Health Research Institute, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

June 6, 2006

First Submitted That Met QC Criteria

June 6, 2006

First Posted (Estimate)

June 7, 2006

Study Record Updates

Last Update Posted (Estimate)

September 29, 2009

Last Update Submitted That Met QC Criteria

September 27, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCT64076
  • ISRCTN86187625
  • CIHR Grant No. MCT64076
  • Final Protocol Nov.20, 2003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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