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CompletedNCT02027077Updated Jan 18, 2019

Evaluating a Small Change Approach to Preventing Long Term Weight Gain in Overweight and Obese Adults

An interventional study of Control group and Lifestyle counselling in Obesity and Prevention of Weight Gain, sponsored by Queen's University. Completed at 1 site in Canada. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-18.

Sponsored by Queen's University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
344
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity
  • Prevention of Weight Gain

Keywords

  • physical activity
  • diet
  • small change
  • behavior change
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 344 is above the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Queen's University is the lead sponsor of 207 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
344 participants (actual)

Study arms

  • Active comparator
    Control group

    Control group

    Behavioral: Control group

  • Active comparator
    Lifestyle counseling

    Behavioral intervention group

    Behavioral: Lifestyle counselling

Interventions

  • BehavioralControl 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

  • BehavioralLifestyle counselling

    Participants will follow a prescribed behavioral intervention program seeking small changes in both physical activity and diet for the duration of the intervention.

06

What researchers measure

Primary outcomes

  1. Change in Body Weight

    Time frame: 2 years

Secondary outcomes

  1. Waist Circumference

    Time frame: 2 years

  2. Physical Activity

    Measured by pedometer and self-report

    Time frame: 2 years

  3. Total and regional body composition measures

    Total fat, abdominal subcutaneous and visceral fat and total lean mass measured by DXA.

    Time frame: 2-years

Other outcomes

  1. Cardiometabolic risk factors

    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

07

Study locations

1 site
  • School of Kinesiology and Helath Studies
    Kingston, Ontario K7L 3N6, Canada
08

References and documents

Publications

  • 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. PubMed 35256388 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02027077
Lead sponsor
Queen's University
Responsible party
Dr. Bob Ross (Professor, Queen's University) — Principal investigator
First posted
Jan 3, 2014
Start date
Feb 2014
Primary completion
May 30, 2018
Completion
May 30, 2018
Last update
Jan 18, 2019

Study contacts

Robert Ross, PhD
principal investigator · Queen's University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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