ObesityNCT03315247
Tele-CBT Following Bariatric Surgery: Randomized Control Trial
A study testing Telephone-Based CBT in people with Obesity, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Bariatric (weight loss) surgery is the most effective treatment for extreme obesity, but surgery does not treat underlying psychological and behavioural issues. Currently, psychotherapy ("talk therapy") for eating problems is not routinely offered with surgery, and many people start to regain weight one year later. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Telephone-Based CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteCanada
- Study dates
- 9 Feb 2018to 15 Jan 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Received bariatric surgery 1 year ago
- Fluent in English
- Have Internet access to complete online questionnaires.
Who cannot join
- Current active suicidal ideation
- Current poorly controlled psychiatric illness that would render Tele-CBT very difficult, including serious mental illness (i.e., psychotic disorder, bipolar disorder), severe depression (i.e., current major depressive episode diagnosis and Patient Health Questionnaire [PHQ-9]61 score > 20), or severe anxiety (i.e., current anxiety disorder diagnosis and Generalized Anxiety Disorder [GAD-7]62 score >15)
- Current poorly controlled medical illness that would render Tele-CBT very difficult.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telephone-Based Cognitive Behavioural Therapy for Post-Operative Bariatric Surgery Patients: A Randomized Controlled Trial
Bariatric (weight loss) surgery is the most effective treatment for extreme obesity, but surgery does not treat underlying psychological and behavioural issues. Currently, psychotherapy ("talk therapy") for eating problems is not routinely offered with surgery, and many people start to regain weight one year later. Objective: This study will examine if adding a convenient and accessible psychotherapy by phone one year after surgery will lead to increased weight loss two years after surgery. Primary Hypothesis: Relative to the Control group (who will get routine care), the group of individuals who get psychotherapy will have lower weights 2 years after surgery. Secondary Hypotheses: Relative to the Control group, the psychotherapy group will report significantly less maladaptive eating behaviours and medical burden, and significantly greater quality of life. Method: Participants recruited from the Bariatric Surgery Programs at Toronto Western Hospital will be randomly assigned to 1 of 2 groups: 1) Control (Usual Standard of Care) or 2) Tele-CBT (a 7-session telephone-based cognitive behavioural therapy [a type of "talk therapy"] intervention focused on developing coping skills to improve maladaptive thoughts, emotions, and eating behaviours, specifically designed for bariatric surgery patients, delivered 1 year post-surgery). They will have their weight measured and will complete measures of eating behaviour and quality of life prior to the intervention, and again at several time points extending to 2 years post-surgery. Implications: If Telephone-Cognitive Behavioural Therapy (CBT) is found to improve bariatric surgery outcomes, it could become the standard of care in Canadian bariatric surgery programs and beyond, and be routinely offered to patients who cannot feasibly attend CBT sessions due to physical or practical barriers.
- Conditions
- Obesity
- Being tested
- Telephone-Based CBT
- Keywords
- Obesity, Bariatric Surgery, Bariatrics, Cognitive Therapy, Binge Eating
- Medical subject headings
- Obesity, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-Based CBTBehavioural
Also called Tele-CBT
The Tele-CBT sessions focus on introducing the cognitive behavioural model of overeating and obesity, scheduling healthy meals and snacks at regular time intervals and recording consumption using food records, scheduling pleasurable alternative activities to overeating, identifying and planning for difficult eating scenarios, and reducing vulnerability to overeating by solving problems and challenging negative thoughts. Participants are expected to complete CBT homework between sessions, such as completing food records, engaging in pleasurable and self-care activities, and completing a variety of worksheets.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | No intervention | Participants assigned to the Treatment as Usual group will attend routine clinic visits at the Toronto Western Hospital Bariatrics Surgery Program (TWH-BSP). These visits generally include education on bariatric surgery and nutrition. Patients meet with select members of the multidisciplinary team at 1, 2, and 3 years post-surgery, and may attend an optional monthly support group. Participants' service utilization (i.e., attendance at optional sessions) will be documented and compared across groups. |
| Telephone-Based CBT | Experimental | The Tele-CBT intervention will be delivered 1 year following bariatric surgery. Participants will receive 6 weekly Telephone-based Cognitive Behavioural Therapy sessions and 1 final "booster" session 1 month later, all approximately 55-minutes in duration and scheduled at a time convenient for the participants. Receives: Behavioral: Telephone-Based CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Change in weight measured in kg
Measured: 1.25, 1.5, 2, 3 years post-surgery
Secondary outcomes (9)
Changes in obesity-related medical comorbidities - Medication Burden
Medication pill burden/Type 2 Diabetes Mellitus (T2DM) specific medication burden
Measured: 2 and 3 years post-surgery
Changes in obesity-related medical comorbidities - Medical Treatments
Discontinuation of medical treatments
Measured: 2 and 3 years post-surgery
Changes in obesity-related medical comorbidities - T2DM
Remission of T2DM (normalization of lab values discontinuation of medical treatments and remission of T2DM/normalization of lab values)
Measured: 2 and 3 years post-surgery
Changes in eating pathology - Emotional Eating
Measured by the Emotional Eating Scale (EES). The EES is a 25-item self-report measure that assesses the tendency to cope with negative affect by eating. Respondents are presented with 25 emotions and are asked to rate the strength of their urge to eat on a scale from 1 (no desire to eat) to 5 (an overwhelming urge to eat) when experiencing each of the emotions. The total EES score is calculated as a sum of all 25 self-report answers. The EES consists of 3 subscales reflecting anger/frustration, anxiety, and depression. The EES subscale scores are calculated as a sum of all self-report answers of emotions that fall within the subscale categories.
Measured: 1.25, 1.5, 2, and 3 years post-surgery
Changes in eating pathology - Binge Eating
Measured by the Binge Eating Scale (BES). The BES is a 16-item self-report measure that assesses the presence of binge eating behaviour indicative of an eating disorder. It was devised specifically for use with obese individuals. Respondents are asked to rate the way they feel about their eating behaviour from 1 (statements indicating they see no problem with their eating behaviour) to 4 (statements indicating they see a severe problem with their eating behaviour). Scores on the BES range from 0 to 46 with the total score calculated as a sum of all 16 self-report answers. Moderate and severe levels of binge eating correspond to cut-off scores of 18 and 27.
Measured: 1.25, 1.5, 2, and 3 years post-surgery
Changes in eating pathology - Loss of Control
Measured by the Loss of Control over Eating Scale (LOCES-Brief). The LOCES-Brief is a 7-item self-report measure that assesses the behavioural and cognitive aspects of loss of control eating, which may occur even in the absence of objectively large eating binges. Respondents are asked to rate the frequency with which they have experienced loss of control over eating over the last month on a scale ranging from 1 (never) to 5 (always). Scores on the LOCES-Brief can range from 7 to 35 with the total score calculated as a sum of all 7 self-report answers.
Measured: 1.25, 1.5, 2, and 3 years post-surgery
Changes in eating pathology - Depression
Measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9-item self-report measure of depression severity. Respondents are asked to rate the frequency with which they have experienced depressive symptoms over the last two weeks on a scale ranging from 0 (not at all) to 3 (nearly every day). Scores on the PHQ-9 can range from 0 to 27 with the total score calculated as a sum of all 9 self-report answers. Mild, moderate, moderately severe, and severe levels of depressive symptoms correspond to cut-off scores of 5, 10, 15, and 20 respectively.
Measured: 1.25, 1.5, 2, and 3 years post-surgery
Changes in eating pathology - Quality of Life
Measured by the EuroQol (EQ-5D-5L). The EQ-5D-5L is a 25 item self-report measure of health-related quality of life. The EQ-5D-5L covers the 5 domains of mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each domain consists of 5 statements ranging from "I have no problems" to "I am unable to/I have extreme problems". Respondents are also asked to rate how good or bad their health is at the current point in time on a scale from 0 (worst health you can imagine) to 100 (best health you can imagine).
Measured: 1.25, 1.5, 2, and 3 years post-surgery
Changes in eating pathology - Anxiety
Measured by the Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 is a 7-item self report measure of anxiety severity. It was originally developed to diagnose generalized anxiety disorder, but it has also proved to be a good screening instrument for other disorders including panic disorder, social phobia, and post-traumatic stress disorder. Respondents are asked to rate the frequency with which they have experienced anxiety symptoms over the last two weeks on a scale ranging from 0 (not at all) to 3 (nearly every day). Scores on the GAD-7 can range from 0 to 21 with the total score calculated as a sum of all 7 self-report answers. Mild, moderate, and severe levels of anxiety symptoms correspond to cut-off scores on 5, 10, and 15 respectively.
Measured: 1.25, 1.5, 2, and 3 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start9 Feb 2018
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjeev Sockalingam, University Health Network, Toronto
- Investigators
- Sanjeev Sockalingam, MD, FRCPC, Principal investigator, University of Toronto, University Health NetworkStephanie Cassin, PhD, CPsych, Principal investigator, Toronto Metropolitan UniversityRaed Hawa, MD, FRCPC, Study director, University of Toronto, University Health NetworkSusan Wnuk, PhD, CPsych, Study director, University of Toronto, University Health NetworkTimothy Jackson, MD, FRCPC, Study director, University of Toronto, University Health NetworkLorraine Lipscombe, MD, FRCPC, Study director, Women's College HospitalAllan Okrainec, MD, FRCPC, Study director, University of Toronto, University Health NetworkGeorge Tomlinson, PhD, Study director, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315247
- Sponsor's protocol ID
- 17-5655
- Other IDs
- 376045
- Status last verified
- May 2024
- First submitted
- 31 Aug 2017
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly in order to protect patient confidentiality. Aggregate and anonymous data will be shared in peer reviewed journal articles and scientific presentations.
Publications
Meany G, Conceicao E, Mitchell JE. Binge eating, binge eating disorder and loss of control eating: effects on weight outcomes after bariatric surgery. Eur Eat Disord Rev. 2014 Mar;22(2):87-91. doi: 10.1002/erv.2273.
PubMed 24347539Sheets CS, Peat CM, Berg KC, White EK, Bocchieri-Ricciardi L, Chen EY, Mitchell JE. Post-operative psychosocial predictors of outcome in bariatric surgery. Obes Surg. 2015 Feb;25(2):330-45. doi: 10.1007/s11695-014-1490-9.
PubMed 25381119DiGiorgi M, Rosen DJ, Choi JJ, Milone L, Schrope B, Olivero-Rivera L, Restuccia N, Yuen S, Fisk M, Inabnet WB, Bessler M. Re-emergence of diabetes after gastric bypass in patients with mid- to long-term follow-up. Surg Obes Relat Dis. 2010 May-Jun;6(3):249-53. doi: 10.1016/j.soard.2009.09.019. Epub 2009 Oct 29.
PubMed 20510288Shah M, Simha V, Garg A. Review: long-term impact of bariatric surgery on body weight, comorbidities, and nutritional status. J Clin Endocrinol Metab. 2006 Nov;91(11):4223-31. doi: 10.1210/jc.2006-0557. Epub 2006 Sep 5.
PubMed 16954156Cassin SE, Park KE, Leung SE, Ma C, Tomlinson G, Hawa R, Wnuk S, Jackson T, Urbach D, Okrainec A, Brown J, Sandre D, Sockalingam S. A Randomized-Controlled Trial Examining Telephone-Based Cognitive Behavioral Therapy for Patients After Metabolic and Bariatric Surgery: 18 Month Follow-up Results. Obes Surg. 2025 Oct;35(10):4103-4113. doi: 10.1007/s11695-025-08163-2. Epub 2025 Sep 1.
PubMed 40887513Sockalingam S, Leung SE, Ma C, Tomlinson G, Hawa R, Wnuk S, Jackson T, Urbach D, Okrainec A, Brown J, Sandre D, Cassin SE. Efficacy of Telephone-Based Cognitive Behavioral Therapy for Weight Loss, Disordered Eating, and Psychological Distress After Bariatric Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2327099. doi: 10.1001/jamanetworkopen.2023.27099.
PubMed 37535357Sockalingam S, Leung SE, Ma C, Hawa R, Wnuk S, Dash S, Jackson T, Cassin SE. The Impact of Telephone-Based Cognitive Behavioral Therapy on Mental Health Distress and Disordered Eating Among Bariatric Surgery Patients During COVID-19: Preliminary Results from a Multisite Randomized Controlled Trial. Obes Surg. 2022 Jun;32(6):1884-1894. doi: 10.1007/s11695-022-05981-6. Epub 2022 Feb 25.
PubMed 35218006
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone-Based Cognitive Behavioural Therapy for Post-Operative Bariatric Surgery Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03315247
- Acronym / sponsor ID
- 17-5655
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric Surgery, Bariatrics, Cognitive Therapy, Binge Eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 20 Oct 2017 (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.
Bariatric (weight loss) surgery is the most effective treatment for extreme obesity, but surgery does not treat underlying psychological and behavioural issues. Currently, psychotherapy ("talk therapy") for eating problems is not routinely offered with surgery, and many people start to regain weight one year later. Objective: This study will examine if adding a convenient and accessible psychotherapy by phone one year after surgery will lead to increased weight loss two years after surgery. Primary Hypothesis: Relative to the Control group (who will get routine care), the group of individuals who get psychotherapy will have lower weights 2 years after surgery. Secondary Hypotheses: Relative to the Control group, the psychotherapy group will report significantly less maladaptive eating behaviours and medical burden, and significantly greater quality of life. Method: Participants recruited from the Bariatric Surgery Programs at Toronto Western Hospital will be randomly assigned to 1 of 2 groups: 1) Control (Usual Standard of Care) or 2) Tele-CBT (a 7-session telephone-based cognitive behavioural therapy [a type of "talk therapy"] intervention focused on developing coping skills to improve maladaptive thoughts, emotions, and eating behaviours, specifically designed for bariatric surgery patients, delivered 1 year post-surgery). They will have their weight measured and will complete measures of eating behaviour and quality of life prior to the intervention, and again at several time points extending to 2 years post-surgery. Implications: If Telephone-Cognitive Behavioural Therapy (CBT) is found to improve bariatric surgery outcomes, it could become the standard of care in Canadian bariatric surgery programs and beyond, and be routinely offered to patients who cannot feasibly attend CBT sessions due to physical or practical barriers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | –Participants assigned to the Treatment as Usual group will attend routine clinic visits at the Toronto Western Hospital Bariatrics Surgery Program (TWH-BSP). These visits generally include education on bariatric surgery and nutrition. Patients meet with select members of the multidisciplinary team at 1, 2, and 3 years post-surgery, and may attend an optional monthly support group. Participants' service utilization (i.e., attendance at optional sessions) will be documented and compared across groups. |
| Telephone-Based CBT | Experimental | Behavioral: Telephone-Based CBTThe Tele-CBT intervention will be delivered 1 year following bariatric surgery. Participants will receive 6 weekly Telephone-based Cognitive Behavioural Therapy sessions and 1 final "booster" session 1 month later, all approximately 55-minutes in duration and scheduled at a time convenient for the participants. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Received bariatric surgery 1 year ago
- Fluent in English
- Have Internet access to complete online questionnaires.
Key exclusion criteria (3 listed)
- Current active suicidal ideation
- Current poorly controlled psychiatric illness that would render Tele-CBT very difficult, including serious mental illness (i.e., psychotic disorder, bipolar disorder), severe depression (i.e., current major depressive episode diagnosis and Patient Health Questionnaire [PHQ-9]61 score > 20), or severe anxiety (i.e., current anxiety disorder diagnosis and Generalized Anxiety Disorder [GAD-7]62 score >15)
- Current poorly controlled medical illness that would render Tele-CBT very difficult.
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 |
|---|---|---|
| Telephone-Based CBTAlso: Tele-CBTThe Tele-CBT sessions focus on introducing the cognitive behavioural model of overeating and obesity, scheduling healthy meals and snacks at regular time intervals and recording consumption using food records, scheduling pleasurable alternative activities to overeating, identifying and planning for difficult eating scenarios, and reducing vulnerability to overeating by solving problems and challenging negative thoughts. Participants are expected to complete CBT homework between sessions, such as completing food records, engaging in pleasurable and self-care activities, and completing a variety of worksheets. | Behavioural | Telephone-Based CBT |
Primary outcome
Change in Weight
Time frame: 1.25, 1.5, 2, 3 years post-surgery
Change in weight measured in kg
9 secondary outcomes
Changes in obesity-related medical comorbidities - Medication Burden
Time frame: 2 and 3 years post-surgery
Changes in obesity-related medical comorbidities - Medical Treatments
Time frame: 2 and 3 years post-surgery
Changes in obesity-related medical comorbidities - T2DM
Time frame: 2 and 3 years post-surgery
Changes in eating pathology - Emotional Eating
Time frame: 1.25, 1.5, 2, and 3 years post-surgery
Changes in eating pathology - Binge Eating
Time frame: 1.25, 1.5, 2, and 3 years post-surgery
Changes in eating pathology - Loss of Control
Time frame: 1.25, 1.5, 2, and 3 years post-surgery
Changes in eating pathology - Depression
Time frame: 1.25, 1.5, 2, and 3 years post-surgery
Changes in eating pathology - Quality of Life
Time frame: 1.25, 1.5, 2, and 3 years post-surgery
Changes in eating pathology - Anxiety
Time frame: 1.25, 1.5, 2, and 3 years post-surgery
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 10 May 2024.
- Background: PubMed 24347539Meany G, Conceicao E, Mitchell JE. Binge eating, binge eating disorder and loss of control eating: effects on weight outcomes after bariatric surgery. Eur Eat Disord Rev. 2014 Mar;22(2):87-91. doi: 10.1002/erv.2273.
- Background: PubMed 25381119Sheets CS, Peat CM, Berg KC, White EK, Bocchieri-Ricciardi L, Chen EY, Mitchell JE. Post-operative psychosocial predictors of outcome in bariatric surgery. Obes Surg. 2015 Feb;25(2):330-45. doi: 10.1007/s11695-014-1490-9.
- Background: PubMed 20510288DiGiorgi M, Rosen DJ, Choi JJ, Milone L, Schrope B, Olivero-Rivera L, Restuccia N, Yuen S, Fisk M, Inabnet WB, Bessler M. Re-emergence of diabetes after gastric bypass in patients with mid- to long-term follow-up. Surg Obes Relat Dis. 2010 May-Jun;6(3):249-53. doi: 10.1016/j.soard.2009.09.019. Epub 2009 Oct 29.
- Background: PubMed 16954156Shah M, Simha V, Garg A. Review: long-term impact of bariatric surgery on body weight, comorbidities, and nutritional status. J Clin Endocrinol Metab. 2006 Nov;91(11):4223-31. doi: 10.1210/jc.2006-0557. Epub 2006 Sep 5.
- Derived from this study: PubMed 40887513Cassin SE, Park KE, Leung SE, Ma C, Tomlinson G, Hawa R, Wnuk S, Jackson T, Urbach D, Okrainec A, Brown J, Sandre D, Sockalingam S. A Randomized-Controlled Trial Examining Telephone-Based Cognitive Behavioral Therapy for Patients After Metabolic and Bariatric Surgery: 18 Month Follow-up Results. Obes Surg. 2025 Oct;35(10):4103-4113. doi: 10.1007/s11695-025-08163-2. Epub 2025 Sep 1.
- Derived from this study: PubMed 37535357Sockalingam S, Leung SE, Ma C, Tomlinson G, Hawa R, Wnuk S, Jackson T, Urbach D, Okrainec A, Brown J, Sandre D, Cassin SE. Efficacy of Telephone-Based Cognitive Behavioral Therapy for Weight Loss, Disordered Eating, and Psychological Distress After Bariatric Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2327099. doi: 10.1001/jamanetworkopen.2023.27099.
- Derived from this study: PubMed 35218006Sockalingam S, Leung SE, Ma C, Hawa R, Wnuk S, Dash S, Jackson T, Cassin SE. The Impact of Telephone-Based Cognitive Behavioral Therapy on Mental Health Distress and Disordered Eating Among Bariatric Surgery Patients During COVID-19: Preliminary Results from a Multisite Randomized Controlled Trial. Obes Surg. 2022 Jun;32(6):1884-1894. doi: 10.1007/s11695-022-05981-6. Epub 2022 Feb 25.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly in order to protect patient confidentiality. Aggregate and anonymous data will be shared in peer reviewed journal articles and scientific presentations.
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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.
Sanjeev Sockalingam, MD, FRCPC principal investigator
University of Toronto, University Health Network
Stephanie Cassin, PhD, CPsych principal investigator
Toronto Metropolitan University
Raed Hawa, MD, FRCPC study director
University of Toronto, University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-Based CBT in people with Obesity, run by University Health Network, Toronto 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 3 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 10 May 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?
Change in Weight (time frame: 1.25, 1.5, 2, 3 years post-surgery). 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 NCT03315247, which also lists 7 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 10 May 2024.