Prevention and Reduction of Obesity Through Active Living - Full Text View

Prevention and Reduction of Obesity Through Active Living (PROACTIVE)

This study is ongoing, but not recruiting participants.

First Received: April 21, 2008 Last Updated: October 9, 2008 History of Changes

Sponsors and Collaborators:	Queen's University Canadian Institutes of Health Research (CIHR)
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00665158

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)

MedlinePlus related topics: Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment
Official Title:	Prevention and Reduction of Obesity Through Active Living

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
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
UC: Active Comparator Usual Care Group	Behavioral: UC (Usual Care Group) Usual Care Group - Treatment Implementation by Primary Care Physician
BI: Active Comparator 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

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

Responsible Party:	Queen's University ( Robert Ross )
Study ID Numbers:	Ross2006
Study First Received:	April 21, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00665158 History of Changes
Health Authority:	Canada: Canadian Institutes of Health Research

Keywords provided by Queen's University:

Abdominal obesity, exercise, behaviour modification

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 07, 2009