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Prevention and Reduction of Obesity Through Active Living (PROACTIVE)

Q

Queen's University

Status

Completed

Conditions

Obesity

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00665158
Ross2006

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

500 participants in 2 patient groups

UC
Active Comparator group
Description:
Usual Care Group
Treatment:
Behavioral: UC (Usual Care Group)
BI
Active Comparator group
Description:
Behavioural Intervention Group
Treatment:
Behavioral: BI (Behavioral Intervention Group)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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