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Prevention and Reduction of Obesity Through Active Living

NCT ID: NCT00665158

Last Updated: 2011-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2010-01-31

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.

Detailed Description

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Conditions

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Obesity

Keywords

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Abdominal obesity, exercise, behaviour modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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UC

Usual Care Group

Group Type ACTIVE_COMPARATOR

UC (Usual Care Group)

Intervention Type BEHAVIORAL

Usual Care Group - Treatment Implementation by Primary Care Physician

BI

Behavioural Intervention Group

Group Type ACTIVE_COMPARATOR

BI (Behavioral Intervention Group)

Intervention Type BEHAVIORAL

Behavioral Intervention Group - Treatment Implementation by Health Educator

Interventions

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UC (Usual Care Group)

Usual Care Group - Treatment Implementation by Primary Care Physician

Intervention Type BEHAVIORAL

BI (Behavioral Intervention Group)

Behavioral Intervention Group - Treatment Implementation by Health Educator

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Bob Ross

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Ross

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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Queen's University : Physical Education Center

Kingston, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 22371872 (View on PubMed)

Other Identifiers

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Ross2006

Identifier Type: -

Identifier Source: org_study_id