ObesityNCT02749552
The Role of Values, Acceptance, and Mindfulness Strategies in Long Term Weight Management
A study testing Acceptance and Commitment Therapy in people with Obesity, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jan 2021to 1 Oct 2023
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI above 30 who are participating in Weight Loss Surgery program at the Nova Scotia Health Authority
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Canada1 site
Weight Loss Surgery - Nova Scotia Health Authority
Halifax, Nova Scotia
About this study
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.
Read the detailed description
Participants will be recruited from the weight loss surgery waitlist and randomly assigned to a brief (5 sessions) ACT intervention or to waitlist control group. A mobile app will be used to encourage daily ACT skill practice and track health behaviours over time. The primary objective of the proposed project is to test whether a brief ACT intervention can result in sustained weight management (at 6 months and 1 year) compared to a waitlist control group. If this brief format of ACT intervention for obesity proves to be effective in encouraging health behaviours and weight loss, it may provide a low cost, sustainable option to enhance much needed obesity management services in Nova Scotia.
- Conditions
- Obesity
- Being tested
- Acceptance and Commitment Therapy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
weight-related interventions using values, acceptance, and mindfulness based on Acceptance and Commitment Therapy
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | ACT intervention Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
health behaviours (self-report questionnaires)
engagement in weight related health behaviours (i.e., dietary choices)
Measured: 5 years
health behaviours (self-report questionnaires)
engagement in weight related health behaviours (i.e., physical activity)
Measured: 5 years
Secondary outcomes (2)
acceptance (self-report questionnaire)
ability to acknowledge and tolerate distressing thoughts, feelings, and sensations (total score is used)
Measured: 5 years
mindfulness (self-report questionnaire)
ability to engage in purposeful, present-moment awareness
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start21 Jan 2021
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dayna Lee-Baggley, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749552
- Sponsor's protocol ID
- 3168
- Status last verified
- Jan 2024
- First submitted
- 8 Apr 2016
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19252962Forman 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.
PubMed 25445199
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Values, Acceptance, and Mindfulness Strategies in Long Term Weight Management
- ClinicalTrials.gov ID
- NCT02749552
- Acronym / sponsor ID
- 3168
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 25 Apr 2016 (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 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.
Detailed description
Participants will be recruited from the weight loss surgery waitlist and randomly assigned to a brief (5 sessions) ACT intervention or to waitlist control group. A mobile app will be used to encourage daily ACT skill practice and track health behaviours over time. The primary objective of the proposed project is to test whether a brief ACT intervention can result in sustained weight management (at 6 months and 1 year) compared to a waitlist control group. If this brief format of ACT intervention for obesity proves to be effective in encouraging health behaviours and weight loss, it may provide a low cost, sustainable option to enhance much needed obesity management services in Nova Scotia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Behavioral: Acceptance and Commitment TherapyACT intervention |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI above 30 who are participating in Weight Loss Surgery program at the Nova Scotia Health Authority
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Acceptance and Commitment Therapyweight-related interventions using values, acceptance, and mindfulness based on Acceptance and Commitment Therapy | Behavioural | Acceptance and Commitment Therapy |
Primary outcome
health behaviours (self-report questionnaires)
Time frame: 5 years
engagement in weight related health behaviours (i.e., dietary choices)
health behaviours (self-report questionnaires)
Time frame: 5 years
engagement in weight related health behaviours (i.e., physical activity)
2 secondary outcomes
acceptance (self-report questionnaire)
Time frame: 5 years
mindfulness (self-report questionnaire)
Time frame: 5 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 5 Jan 2024.
- Background: PubMed 19252962Lillis 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.
- Background: PubMed 25445199Forman 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.
- Individual participant dataSharing planned: No
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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.
Dayna Lee-Baggley principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Obesity, run by Nova Scotia Health Authority 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 1 inclusion and 1 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 5 Jan 2024. 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?
health behaviours (self-report questionnaires) (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT02749552, which also lists 2 linked publications.
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 5 Jan 2024.