Prevention and Reduction of Obesity Through Active Living

Study Overview
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Brief Summary
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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.

Official Title
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Prevention and Reduction of Obesity Through Active Living

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: UC (Usual Care Group)
* Behavioral: BI (Behavioral Intervention Group)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: UC<br>Usual Care Group | Behavioral: UC (Usual Care Group)<br>* Usual Care Group - Treatment Implementation by Primary Care Physician<br>|
| Active Comparator: BI<br>Behavioural Intervention Group | Behavioral: BI (Behavioral Intervention Group)<br>* Behavioral Intervention Group - Treatment Implementation by Health Educator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist Circumference |  | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Syndrome |  | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal obesity, exercise, behaviour modification