- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02749552
The Role of Values, Acceptance, and Mindfulness Strategies in Long Term Weight Management
Obesity is a prevalent, destructive, and costly chronic disease. In 2008, 37% of Canadian adults were measured as overweight, and 25% as obese. Obesity is a risk factor for a number of serious health problems, including type 2 diabetes, asthma, gallbladder disease, osteoarthritis, chronic back pain, several types of cancers (i.e., colorectal, kidney, breast, endometrial, ovarian and pancreatic cancers) and cardiovascular disease (i.e., hypertension, stroke, congestive heart failure and coronary artery disease). In 2008, it was estimated that the annual economic burden of obesity in Canada was $4.6 billion. Given the economic strain and widespread health risks of obesity, there is a clear need to provide effective interventions for obesity.
The purpose of the proposed study is to examine the role of ACT-based interventions in long-term weight maintenance. The proposed study will examine the role of value consistent behaviour, acceptance skills, and mindfulness skills in promoting long-term weight-related health behaviours. Acceptance and Commitment Therapy (ACT) is an empirically supported psychological intervention that emphasizes value consistent behaviours, acceptance skills and mindfulness skills.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada
- Weight Loss Surgery - Nova Scotia Health Authority
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- BMI above 30 who are participating in Weight Loss Surgery program at the Nova Scotia Health Authority
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acceptance and Commitment Therapy
ACT intervention
|
weight-related interventions using values, acceptance, and mindfulness based on Acceptance and Commitment Therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
health behaviours (self-report questionnaires)
Time Frame: 5 years
|
engagement in weight related health behaviours (i.e., dietary choices)
|
5 years
|
|
health behaviours (self-report questionnaires)
Time Frame: 5 years
|
engagement in weight related health behaviours (i.e., physical activity)
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
acceptance (self-report questionnaire)
Time Frame: 5 years
|
ability to acknowledge and tolerate distressing thoughts, feelings, and sensations (total score is used)
|
5 years
|
|
mindfulness (self-report questionnaire)
Time Frame: 5 years
|
ability to engage in purposeful, present-moment awareness
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dayna Lee-Baggley, Nova Scotia Health Authority
Publications and helpful links
General Publications
- Lillis J, Hayes SC, Bunting K, Masuda A. Teaching acceptance and mindfulness to improve the lives of the obese: a preliminary test of a theoretical model. Ann Behav Med. 2009 Feb;37(1):58-69. doi: 10.1007/s12160-009-9083-x. Epub 2009 Feb 28.
- Forman EM, Butryn ML. A new look at the science of weight control: how acceptance and commitment strategies can address the challenge of self-regulation. Appetite. 2015 Jan;84:171-80. doi: 10.1016/j.appet.2014.10.004. Epub 2014 Oct 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 3168
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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