ObesityNCT02027077
Evaluating a Small Change Approach to Preventing Long Term Weight Gain in Overweight and Obese Adults
A study testing Lifestyle counselling in people with Obesity and Prevention of Weight Gain, run by Queen's University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Prevention of Weight Gain
- What is being tested?
- Lifestyle counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to 30 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
School of Kinesiology and Helath Studies
Kingston, Ontario, K7L 3N6
About this study
Official title: 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.
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.
- Conditions
- Obesity, Prevention of Weight Gain
- Being tested
- Control group, Lifestyle counselling
- Keywords
- physical activity, diet, small change, behavior change
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupBehavioural
No prescribed intervention/ Participants asked to follow normal initiatives to engage in physical activity a healthful diet behaviors for the duration of the intervention
Lifestyle counsellingBehavioural
Participants will follow a prescribed behavioral intervention program seeking small changes in both physical activity and diet for the duration of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Control group Receives: Behavioral: Control group |
| Lifestyle counseling | Active comparator | Behavioral intervention group Receives: Behavioral: Lifestyle counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Measured: 2 years
Secondary outcomes (3)
Waist Circumference
Measured: 2 years
Physical Activity
Measured by pedometer and self-report
Measured: 2 years
Total and regional body composition measures
Total fat, abdominal subcutaneous and visceral fat and total lean mass measured by DXA.
Measured: 2-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Bob Ross, Queen's University
- Investigators
- Robert Ross, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027077
- Sponsor's protocol ID
- Ross2013
- Status last verified
- Apr 2017
- First submitted
- 2 Jan 2014
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating a Small Change Approach to Preventing Long Term Weight Gain in Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT02027077
- Acronym / sponsor ID
- Ross2013
- Conditions
- Obesity, Prevention of Weight Gain
- Keywords
- physical activity, diet, small change, behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 3 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Control groupControl group |
| Lifestyle counseling | Active comparator | Behavioral: Lifestyle counsellingBehavioral intervention group |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control groupNo prescribed intervention/ Participants asked to follow normal initiatives to engage in physical activity a healthful diet behaviors for the duration of the intervention | Behavioural | Control group |
| Lifestyle counsellingParticipants will follow a prescribed behavioral intervention program seeking small changes in both physical activity and diet for the duration of the intervention. | Behavioural | Lifestyle counseling |
Primary outcome
Change in Body Weight
Time frame: 2 years
3 secondary outcomes
Waist Circumference
Time frame: 2 years
Physical Activity
Time frame: 2 years
Total and regional body composition measures
Time frame: 2-years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Derived from this study: PubMed 35256388Ross 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Ross, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle counselling in people with Obesity and Prevention of Weight Gain, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02027077, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2019.