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OpenTrials
Completed

NCT Number: NCT00665158

Prevention and Reduction of Obesity Through Active Living

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.

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Key information

Conditions

Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's University : Physical Education Center

Kingston, Ontario, K7L 3N6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UC (Usual Care Group)

Behavioral

Usual Care Group - Treatment Implementation by Primary Care Physician

BI (Behavioral Intervention Group)

Behavioral

Behavioral Intervention Group - Treatment Implementation by Health Educator

Primary outcomes

  1. Waist Circumference

    Time frame: 2 Years

Secondary outcomes

  1. Metabolic Syndrome

    Time frame: 2 Years

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Acronym: PROACTIVE

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Apr 23, 2008
Registry last updated
Oct 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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