Viewing Study NCT00334269



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Study NCT ID: NCT00334269
Status: COMPLETED
Last Update Posted: 2009-09-29
First Post: 2006-06-06

Brief Title: Study of Health Assessment and Risk Evaluation in Aboriginal Peoples Action Toward Obesity Prevention SHARE-AP Action
Sponsor: Population Health Research Institute
Organization: Population Health Research Institute

Study Overview

Official Title: Study of Health Assessment and Risk Evaluation SHARE in Aboriginal Peoples AP Action Toward Obesity Prevention SHARE-AP Action
Status: COMPLETED
Status Verified Date: 2009-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
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 afterschoolwork physical activity programs and nutritional workshops Control families receive written material including Canadas Food Guide to Healthy Eating and Canadas Physical Activity Guide to Healthy Active Living which outlines suggestions for healthy living and none of the interventions

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
ISRCTN86187625 None None None
CIHR Grant No MCT64076 None None None
Final Protocol Nov20 2003 None None None