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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027077
• Other study ID #: Ross2013
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: May 30, 2018

Study information

• Verified date: April 2017
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight
• Prevention of Weight Gain
• Weight Gain

Intervention

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

Locations

Country	Name	City	State
Canada	School of Kinesiology and Helath Studies	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	2 years
Primary	Change in Body Weight		2 years
Secondary	Waist Circumference		2 years
Secondary	Physical Activity	Measured by pedometer and self-report	2 years
Secondary	Total and regional body composition measures	Total fat, abdominal subcutaneous and visceral fat and total lean mass measured by DXA.	2-years