NCT00665158

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

October 31, 2011

Status Verified

October 1, 2008

Enrollment Period

6.3 years

First QC Date

April 21, 2008

Last Update Submit

October 27, 2011

Conditions

Obesity

Keywords

Abdominal obesity, exercise, behaviour modification

Outcome Measures

Primary Outcomes (1)

  • Waist Circumference

    2 Years

Secondary Outcomes (1)

  • Metabolic Syndrome

    2 Years

Study Arms (2)

UC

ACTIVE COMPARATOR

Usual Care Group

Behavioral: UC (Usual Care Group)

BI

ACTIVE COMPARATOR

Behavioural Intervention Group

Behavioral: BI (Behavioral Intervention Group)

Interventions

UC (Usual Care Group)BEHAVIORAL

Usual Care Group - Treatment Implementation by Primary Care Physician

UC
BI (Behavioral Intervention Group)BEHAVIORAL

Behavioral Intervention Group - Treatment Implementation by Health Educator

BI

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's University : Physical Education Center

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 22371872DERIVED

MeSH Terms

Conditions

ObesityObesity, AbdominalMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Robert Ross

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 21, 2008

First Posted

April 23, 2008

Study Start

September 1, 2003

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

October 31, 2011

Record last verified: 2008-10

Locations

CA(1)