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Prevention and Reduction of Obesity Through Active Living (PROACTIVE)

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ClinicalTrials.gov Identifier: NCT00665158
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : October 31, 2011
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Bob Ross, Queen's University

Brief Summary:
We will perform a randomized, controlled trial, the primary aim of which is to assess the effectiveness of a behavioral-based physical activity program in the prevention and treatment of obesity and related co-morbid conditions in a primary care setting. We hypothesize that the prevention and/or reduction of obesity and related co-morbidities in patients randomized to an individualized education and behavior counseling group will be greater by comparison to those randomized to a group that receives standard care alone.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: UC (Usual Care Group) Behavioral: BI (Behavioral Intervention Group) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prevention and Reduction of Obesity Through Active Living
Study Start Date : September 2003
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
Active Comparator: UC
Usual Care Group
Behavioral: UC (Usual Care Group)
Usual Care Group - Treatment Implementation by Primary Care Physician
Active Comparator: BI
Behavioural Intervention Group
Behavioral: BI (Behavioral Intervention Group)
Behavioral Intervention Group - Treatment Implementation by Health Educator



Primary Outcome Measures :
  1. Waist Circumference [ Time Frame: 2 Years ]

Secondary Outcome Measures :
  1. Metabolic Syndrome [ Time Frame: 2 Years ]


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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women between 25 and 65 years of age.
  • Sedentary lifestyle (planned physical activity for the purpose of health one day per week or less).
  • Abdominally obese (waist circumference greater than 88 and 102 cm for women and men respectively).
  • Weight stable (± 2 kg) for 6 months prior to the beginning of the study.
  • BMI between 25 and 34.9 kg/m2 (Because a lifestyle-based intervention alone for obesity reduction is ideal for persons with a BMI greater less than 35, and, that 94% of overweight and obese Canadian adults have a BMI between 25 and 34.9 kg/m2, subjects with a BMI 35 or greater will be excluded).

Exclusion Criteria:

  • Physical impairment which would make the intervention very difficult, or unsafe according to the patient's physician including history of myocardial infarction, stroke, coronary bypass surgery or angioplasty in the last 6 months; peripheral artery disease, unstable angina or ischemia, uncontrolled or insulin dependent diabetes mellitus.
  • Alcohol consumption > 21 drinks per week.
  • Plans to move from the area.
  • Participating in another research study.
  • Clinically judged to be unsuitable for participation or adherence
  • Inability or unwillingness to provide informed consent.
  • For women, planned pregnancy in the next 3 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665158


Locations
Canada, Ontario
Queen's University : Physical Education Center
Kingston, Ontario, Canada, K7L 3N6
Sponsors and Collaborators
Queen's University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Robert Ross Queen's University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bob Ross, Professor, Queen's University
ClinicalTrials.gov Identifier: NCT00665158     History of Changes
Other Study ID Numbers: Ross2006
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: October 31, 2011
Last Verified: October 2008

Keywords provided by Bob Ross, Queen's University:
Abdominal obesity, exercise, behaviour modification

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