ObesityNCT03743844
Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity
A study testing Compassion-focused psychoeducation group in people with Obesity and Mood Disorders, run by University of Western Ontario, Canada at 1 site in Canada.
Trial summary
Women with mood disorders are vulnerable to the negative consequences associated with obesity, and face considerable challenges with adherence to behavioral weight management interventions. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Mood Disorders
- What is being tested?
- Compassion-focused psychoeducation group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteCanada
- Study dates
- 22 Oct 2018to 13 Mar 2021
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed of the nature of the study and have agreed to and are able to read, review, and sign the informed consent form. The informed consent document will be written in English, therefore the volunteer must have the ability to read and communicate in English.
- Female participants 18 - 65 years of age, inclusive, at the time of screening.
- Available and able to attend weekly group meeting on assigned dates.
- Diagnosis of major depressive disorder or bipolar disorder by a physician within the past 12 months, as indicated in WMC medical records and confirmed by MINI.
- Actively pursuing lifestyle weight management at WMC, with evidence of booked follow-up appointment.
- Weight status of at least 25kg/m2, as indicated by data from last appointment at WMC.
- Access to a computer and email account in order to complete online questionnaires
Who cannot join
- Enrolled in surgical management of obesity at WMC.
- Active substance abuse/dependence disorder, current suicidality, or active episode of psychosis.
- Presence of a hearing or visual impairment that will prevent completing the online surveys and from participating in a group discussion weekly meeting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compassion-focused Intervention for Women With Mood Disorders Seeking Treatment for Obesity
Women with mood disorders are vulnerable to the negative consequences associated with obesity, and face considerable challenges with adherence to behavioral weight management interventions. Strategies are needed to support the psychological well-being of this population, and improve adherence to weight-related treatment. The goal of this preliminary study is to determine the acceptability of a group-based compassion-focused psychoeducational intervention among women with mood disorders who are attending a behavioral weight management program.
Read the detailed description
Pilot feasibility trial to examine the acceptability and efficacy of compassion-based intervention in reducing indices of psychopathology (i.e., internalized weight stigma, mood symptoms), and improving weight management outcomes (i.e., physical activity behaviour, dieting behaviour, weight loss) among women with mood disorders undergoing lifestyle weight management. In this proof of concept study, adult females with a diagnosis of major depressive disorder of bipolar disorder will be randomized into two arms: weight management treatment as usual + psychoeducation group; weight management as usual + control.
- Conditions
- Obesity, Mood Disorders
- Being tested
- Compassion-focused psychoeducation group
- Keywords
- weight management, compassion-focused treatment, internalized weight bias, depressive symptoms
- Medical subject headings
- Obesity, Mood Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion-focused psychoeducation groupBehavioural
Attending six 2-hour weekly group-based psychoeducation sessions and participating in mindfulness, meditation, and acceptance-based experiential exercises
| Study group | Role | What they receive |
|---|---|---|
| Compassion-focused psychoeducation group | Experimental | Receiving 2-hours of group-based in-person psychoeducational sessions weekly for 6-weeks. Receives: Behavioral: Compassion-focused psychoeducation group |
| Control group | No intervention | Weight management treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment from community-based clinic
Proportion of eligible participants who agree to participate in the study
Measured: 7-months (from baseline to 6-month follow-up)
Adherence to the 6-week intervention
Proportion of sessions attended, and minutes spent weekly on home practice exercises
Measured: 6 weeks (from baseline to end of treatment)
Secondary outcomes (4)
Changes in internalized weight bias
Weight Bias Internalization Scale (measures internalization of weight bias; mean score calculated, and ranges from 1 to 7)
Measured: 7 months (from baseline to 6-month follow-up)
Changes in depressive symptoms
Beck Depression Inventory (measures depressive symptoms; total score calculated, and ranges from 0 to 63)
Measured: 7 months (from baseline to 6-month follow-up)
Changes in physical activity engagement
International Physical Activity Questionnaire (measures physical activity frequency and intensity; continuous score of MET [Metabolic Equivalent Task] minutes per week)
Measured: 7 months (from baseline to 6-month follow-up)
Future adherence to weight management program
Attending follow-up appointments
Measured: 7 months (from baseline to 6-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start22 Oct 2018
- Primary completion13 Mar 2020
- Study completion13 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Addiction and Mental Health, Wharton Medical Clinic, Women's College Hospital
- Responsible party
- Principal investigator, Dr. Eva Pila, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743844
- Sponsor's protocol ID
- 2018-0075-E
- Status last verified
- May 2023
- First submitted
- 29 Oct 2018
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassion-focused Intervention for Women With Mood Disorders Seeking Treatment for Obesity
- ClinicalTrials.gov ID
- NCT03743844
- Acronym / sponsor ID
- 2018-0075-E
- Conditions
- Obesity, Mood Disorders
- Keywords
- weight management, compassion-focused treatment, internalized weight bias, depressive symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Collaborators
- Centre for Addiction and Mental Health, Wharton Medical Clinic, Women's College Hospital
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2021 (actual)
- First posted
- 16 Nov 2018 (actual)
- 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.
Women with mood disorders are vulnerable to the negative consequences associated with obesity, and face considerable challenges with adherence to behavioral weight management interventions. Strategies are needed to support the psychological well-being of this population, and improve adherence to weight-related treatment. The goal of this preliminary study is to determine the acceptability of a group-based compassion-focused psychoeducational intervention among women with mood disorders who are attending a behavioral weight management program.
Detailed description
Pilot feasibility trial to examine the acceptability and efficacy of compassion-based intervention in reducing indices of psychopathology (i.e., internalized weight stigma, mood symptoms), and improving weight management outcomes (i.e., physical activity behaviour, dieting behaviour, weight loss) among women with mood disorders undergoing lifestyle weight management. In this proof of concept study, adult females with a diagnosis of major depressive disorder of bipolar disorder will be randomized into two arms: weight management treatment as usual + psychoeducation group; weight management as usual + control.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compassion-focused psychoeducation group | Experimental | Behavioral: Compassion-focused psychoeducation groupReceiving 2-hours of group-based in-person psychoeducational sessions weekly for 6-weeks. |
| Control group | No intervention | –Weight management treatment as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed of the nature of the study and have agreed to and are able to read, review, and sign the informed consent form. The informed consent document will be written in English, therefore the volunteer must have the ability to read and communicate in English.
- Female participants 18 - 65 years of age, inclusive, at the time of screening.
- Available and able to attend weekly group meeting on assigned dates.
- Diagnosis of major depressive disorder or bipolar disorder by a physician within the past 12 months, as indicated in WMC medical records and confirmed by MINI.
- Actively pursuing lifestyle weight management at WMC, with evidence of booked follow-up appointment.
Key exclusion criteria (3 listed)
- Enrolled in surgical management of obesity at WMC.
- Active substance abuse/dependence disorder, current suicidality, or active episode of psychosis.
- Presence of a hearing or visual impairment that will prevent completing the online surveys and from participating in a group discussion weekly meeting
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 |
|---|---|---|
| Compassion-focused psychoeducation groupAttending six 2-hour weekly group-based psychoeducation sessions and participating in mindfulness, meditation, and acceptance-based experiential exercises | Behavioural | Compassion-focused psychoeducation group |
Primary outcome
Feasibility of recruitment from community-based clinic
Time frame: 7-months (from baseline to 6-month follow-up)
Proportion of eligible participants who agree to participate in the study
Adherence to the 6-week intervention
Time frame: 6 weeks (from baseline to end of treatment)
Proportion of sessions attended, and minutes spent weekly on home practice exercises
4 secondary outcomes
Changes in internalized weight bias
Time frame: 7 months (from baseline to 6-month follow-up)
Changes in depressive symptoms
Time frame: 7 months (from baseline to 6-month follow-up)
Changes in physical activity engagement
Time frame: 7 months (from baseline to 6-month follow-up)
Future adherence to weight management program
Time frame: 7 months (from baseline to 6-month follow-up)
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 2 Jun 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion-focused psychoeducation group in people with Obesity and Mood Disorders, run by University of Western Ontario, Canada 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 7 inclusion and 3 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 2 Jun 2023. 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?
Feasibility of recruitment from community-based clinic (time frame: 7-months (from baseline to 6-month follow-up)). 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?
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 2 Jun 2023.