- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02027077
Evaluating a Small Change Approach to Preventing Long Term Weight Gain in Overweight and Obese Adults
January 17, 2019 updated by: Dr. Bob Ross, Queen's University
A Randomized Controlled Trial Evaluating a Small Change Approach to Preventing Long Term Weight Gain in Overweight and Obese Adults
Obesity is a major risk factor for disease and a public health problem.
Recent information suggests that while it is possible for most overweight adults to lose a substantial amount of weight, maintaining the weight loss for any extended time (2 to 3 years) is very difficult.
This is because trying to maintain big changes in exercise and/or eating behaviour is very difficult in today's environment that makes sustain big changes in behaviour (Example: eat allot less or exercise allot more) very hard.
In fact at this time health professionals are unsure of how best to help overweight adults maintain big behavioral changes for long periods of time.
In response, we propose that making smaller changes in eating and exercise habits every day may be possible in today's environment and if so, small weight changes may be possible to maintain for long periods of time.
This study is designed to assess whether making small changes in eating and exercise behavior will be associated with sustained weight loss over three (3) years.
The results of the study may have important implications for development of public health messages and clinical guidelines for prevention and treatment of obesity through small changes in both exercise and eating habits.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The prevalence of obesity and associated morbidity among Canadian adults is already high and increasing.
Prevalence estimates for overweight determined from measured height and weight now exceeds 62 % in Canadian adults1; approximately 15.5 million Canadian adults are now overweight and obese1.
Obesity is associated with a wide range of health outcomes from co-morbidities including type 2 diabetes, cardiovascular disease and certain cancers, to psychiatric disorders such as depression1.
Direct costs attributed to obesity in Canada range from 4.6 to 7.1 billion dollars annually1.
Despite agreement concerning the urgent need to address the obesity problem; few strategies have been successful on a wide scale basis.
Past efforts to achieve and sustain weight loss have not been particularly successful.
We3 and others4 have repeatedly demonstrated in randomized controlled trials that most adults are not able to sustain the major changes in behaviour that are required to maintain weight loss long term.
Thus, although it is an admirable goal to substantially reduce the number of overweight or obese Canadians, this goal may be totally out of reach in the short term.
The question then is what can be done to address the obesity problem now?
We propose that a reasonable start point in addressing the obesity problem is to develop behavioural goals for prevention of weight gain.
This strategy can at least keep the problem from getting worse and at best, can reduce obesity rates over time.
Study Type
Interventional
Enrollment (Actual)
344
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 3N6
- School of Kinesiology and Helath Studies
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women between 25 and 65 years of age.
- Overweight or Class I or Class II BMI.
- Walk without assistance.
- Commit to a schedule of assessment visits
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.
- Enrolled within past year in a formal weight loss program
- Reported losing greater than 5% of current body weight in the previous 6 months,
- Smoking
- Plans to move from the area,
- Participating in another research study.
- Clinically judged to be unsuitable for participation or adherence as determined by the participants physician
- Inability or unwillingness to provide informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group
|
No prescribed intervention/ Participants asked to follow normal initiatives to engage in physical activity a healthful diet behaviors for the duration of the intervention
|
Active Comparator: Lifestyle counseling
Behavioral intervention group
|
Participants will follow a prescribed behavioral intervention program seeking small changes in both physical activity and diet for the duration of the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Body Weight
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Waist Circumference
Time Frame: 2 years
|
2 years
|
|
Physical Activity
Time Frame: 2 years
|
Measured by pedometer and self-report
|
2 years
|
Total and regional body composition measures
Time Frame: 2-years
|
Total fat, abdominal subcutaneous and visceral fat and total lean mass measured by DXA.
|
2-years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiometabolic risk factors
Time Frame: 2 years
|
Insulin, glucose, systolic and diastolic blood pressure, triglycerides, LDL- and HDL-cholesterol) , LDL-cholesterol and Apolipoprotien A1, B and inflammatory markers and adipokines including C-reactive protein, IL-6, TNF-alpha and adiponectin.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
May 30, 2018
Study Completion (Actual)
May 30, 2018
Study Registration Dates
First Submitted
January 2, 2014
First Submitted That Met QC Criteria
January 2, 2014
First Posted (Estimate)
January 3, 2014
Study Record Updates
Last Update Posted (Actual)
January 18, 2019
Last Update Submitted That Met QC Criteria
January 17, 2019
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ross2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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