Evaluating a Small Change Approach to Preventing Long Term Weight Gain in Overweight and Obese Adults
Primary Purpose
Obesity, Prevention of Weight Gain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Control group
Lifestyle counselling
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring physical activity, diet, small change, behavior change
Eligibility Criteria
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.
Sites / Locations
- School of Kinesiology and Helath Studies
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control group
Lifestyle counseling
Arm Description
Control group
Behavioral intervention group
Outcomes
Primary Outcome Measures
Change in Body Weight
Secondary Outcome Measures
Waist Circumference
Physical Activity
Measured by pedometer and self-report
Total and regional body composition measures
Total fat, abdominal subcutaneous and visceral fat and total lean mass measured by DXA.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02027077
Brief Title
Evaluating a Small Change Approach to Preventing Long Term Weight Gain in Overweight and Obese Adults
Official Title
A Randomized Controlled Trial Evaluating a Small Change Approach to Preventing Long Term Weight Gain in Overweight and Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Prevention of Weight Gain
Keywords
physical activity, diet, small change, behavior change
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
344 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Control group
Arm Title
Lifestyle counseling
Arm Type
Active Comparator
Arm Description
Behavioral intervention group
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
No prescribed intervention/ Participants asked to follow normal initiatives to engage in physical activity a healthful diet behaviors for the duration of the intervention
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counselling
Intervention Description
Participants will follow a prescribed behavioral intervention program seeking small changes in both physical activity and diet for the duration of the intervention.
Primary Outcome Measure Information:
Title
Change in Body Weight
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Waist Circumference
Time Frame
2 years
Title
Physical Activity
Description
Measured by pedometer and self-report
Time Frame
2 years
Title
Total and regional body composition measures
Description
Total fat, abdominal subcutaneous and visceral fat and total lean mass measured by DXA.
Time Frame
2-years
Other Pre-specified Outcome Measures:
Title
Cardiometabolic risk factors
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Ross, PhD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Kinesiology and Helath Studies
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
35256388
Citation
Ross R, Latimer-Cheung AE, Day AG, Brennan AM, Hill JO. A small change approach to prevent long-term weight gain in adults with overweight and obesity: a randomized controlled trial. CMAJ. 2022 Mar 7;194(9):E324-E331. doi: 10.1503/cmaj.211041.
Results Reference
derived
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Evaluating a Small Change Approach to Preventing Long Term Weight Gain in Overweight and Obese Adults
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