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Prevention and Reduction of Obesity Through Active Living

Prevention and Reduction of Obesity Through Active Living

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00665158
Acronym
PROACTIVE
Enrollment
500
Registered
2008-04-23
Start date
2003-09-30
Completion date
2010-01-31
Last updated
2011-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Abdominal obesity, exercise, behaviour modification

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.

Interventions

BEHAVIORALUC (Usual Care Group)

Usual Care Group - Treatment Implementation by Primary Care Physician

BEHAVIORALBI (Behavioral Intervention Group)

Behavioral Intervention Group - Treatment Implementation by Health Educator

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Queen's University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Waist Circumference2 Years

Secondary

MeasureTime frame
Metabolic Syndrome2 Years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026