Prevention and Reduction of Obesity Through Active Living (PROACTIVE)

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Bob Ross, Queen's University
ClinicalTrials.gov Identifier:
NCT00665158
First received: April 21, 2008
Last updated: October 27, 2011
Last verified: October 2008
  Purpose

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 Intervention
Obesity
Behavioral: UC (Usual Care Group)
Behavioral: BI (Behavioral Intervention Group)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prevention and Reduction of Obesity Through Active Living

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Waist Circumference [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Metabolic Syndrome [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: September 2003
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Queen's University

Additional 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
Study First Received: April 21, 2008
Last Updated: October 27, 2011
Health Authority: Canada: Canadian Institutes of Health Research

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

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

ClinicalTrials.gov processed this record on September 18, 2014