Clinical trial NCT00665158: Prevention and Reduction of Obesity Through Active Living
Official title: Prevention and Reduction of Obesity Through Active Living
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Abdominal obesity, exercise, behaviour modification
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2008-04-23
Enrollment: 500
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Waist Circumference
timeFrame: 2 Years
Secondary outcomes:
measure: Metabolic Syndrome
timeFrame: 2 Years
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University : Physical Education Center
state: Ontario
Study officials:
affiliation: Queen's University
name: Robert Ross
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ross R, Lam M, Blair SN, Church TS, Godwin M, Hotz SB, Johnson A, Katzmarzyk PT, Levesque L, MacDonald S. Trial of prevention and reduction of obesity through active living in clinical settings: a randomized controlled trial. Arch Intern Med. 2012 Mar 12;172(5):414-24. doi: 10.1001/archinternmed.2011.1972. Epub 2012 Feb 27.