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

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT00334269
First received: June 6, 2006
Last updated: September 27, 2009
Last verified: September 2009
  Purpose

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


Condition Intervention
Obesity
Behavioral: Health messaging at weekly home visits by health counsellor
Behavioral: Weekly home delivery of bottled spring water
Behavioral: Weekly afterschool physical activity program for 5-18y.o.
Behavioral: Cooking classes and grocery store tours with dietician
Behavioral: Pedometers to track/increase weekly physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study of Health Assessment and Risk Evaluation (SHARE) in Aboriginal Peoples (AP) Action Toward Obesity Prevention (SHARE-AP Action)

Resource links provided by NLM:


Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 174
Study Start Date: May 2004
Estimated Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   5 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334269

Locations
Canada, Ontario
SHARE-AP Office, Six Nations Health Services P.O. Box 5000
Ohsweken, Ontario, Canada, N0A 1M0
Sponsors and Collaborators
Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Sonia S Anand, MD, PhD Population Health Research Institute, McMaster University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00334269     History of Changes
Other Study ID Numbers: MCT64076, ISRCTN86187625, CIHR Grant No. MCT64076, Final Protocol Nov.20, 2003
Study First Received: June 6, 2006
Last Updated: September 27, 2009
Health Authority: Canada: Health Canada

Keywords provided by Population Health Research Institute:
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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014