Psoriatic ArthritisPhase 1NCT05225623
Small Changes Behavioural Weight Loss Treatment Approach for Psoriatic Arthritis Patients With Comorbid Obesity
A Phase 1 study testing BWLT in people with Psoriatic Arthritis and Obesity, run by University of Calgary at 1 site in Canada.
Trial summary
Psoriatic Arthritis (PsA) is a type of auto-immune condition that affects roughly 90,000 Canadians. Patients with PsA often experience joint pain, skin problems, and issues with mobility that negatively impact their quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis, Obesity
- What is being tested?
- BWLT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2022to 22 Sep 2023
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ years old,
- new or previous diagnosis of symptomatic psoriatic arthritis
- BMI ≥30kg/m2),
- willing to participate in a BWLT program,
- can speak and write in English to complete surveys,
- able to participate in virtual Zoom meetings (I.e., access to a computer with email, internet and a webcam)
Who cannot join
- unstable ischemic cardiovascular disease
- severe pulmonary disease
- currently pregnant or breastfeeding
- active substance use disorder (drug or alcohol),
- currently participating in another structured weight-loss program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Community-based Adaptation of the Small Changes Behavioural Weight Loss Treatment Approach for Psoriatic Arthritis Patients With Comorbid Obesity
Psoriatic Arthritis (PsA) is a type of auto-immune condition that affects roughly 90,000 Canadians. Patients with PsA often experience joint pain, skin problems, and issues with mobility that negatively impact their quality of life. Compared to the general population, patients with PsA are at a higher risk of having obesity (excess body weight). Although there is no cure for PsA, medications can be helpful for symptoms, and weight loss can provide an added benefit to the effectiveness of medications.
Behavioral weight loss treatment (BWLT) is a proven way to lose weight and keep it off. BWLT usually includes individual or group sessions with a health professional to learn strategies and tools to change behaviours and thoughts in order to support weight loss. However, few studies have designed a BWLT with the unique needs of patients with PsA in mind.
Read more
Before testing new treatments for chronic disease in large, expensive studies, it is important to do smaller-scale research to make sure that a future large study will be successful. In line with this, the objective of our study is to test the feasibility of a future, large study of a BWLT for patients with PsA and obesity. In other words, our small feasibility study will investigate how convenient, reasonable, and acceptable the future study's procedures are, using a small group of people with PsA and obesity.
People who have PsA and obesity will take either a special BWLT program, or receive usual care for PsA from a community-based rheumatologist. Those in the BWLT group will complete 16 online group sessions to help them learn cognitive and behavioral changes to help improve their health and manage weight. After 24 weeks, we will determine study completion rates, examine patient satisfaction, and assess whether the BWLT was provided to people as-designed. We believe this research will help with efforts to provide more effective treatments to patients with PsA to help them lose weight and improve their quality of life through reduced pain and symptoms.
Read the detailed description
Background: Psoriatic Arthritis (PsA) is an inflammatory auto-immune disorder that impacts approximately 3-in-10 patients with skin psoriasis. Compared to other rheumatologic conditions, patients with PsA are at a higher risk of having comorbid obesity (i.e., BMI ≥30 kg/m2; present in 44% of PsA cases). Treating patients with PsA and comorbid obesity presents a unique challenge due to added complications of attenuated pharmacological response to treatment, and mobility issues that impact quality of life for patients. While weight-loss is known to help alleviate symptom burden and improve quality of life in patients with PsA and comorbid obesity, few studies have investigated behavioural weight-loss treatment (BWLT) in patients with PsA to support sustained weight-loss over time.
Aims: The primary aim of the proposed trial will evaluate feasibility metrics (i.e., recruitment rate, drop-out, intervention fidelity, acceptability) of a randomized controlled clinical trial testing an adaptation of a validated "small changes"-based BWLT approach. The secondary aim is to examine differences in mean weight loss, self-reported PsA symptoms (e.g., pain, mobility) and health related quality of life (HRQOL) between patients randomized to BWLT versus patients in the control condition who receive treatment as usual (at a community-based rheumatology clinic).
Methods: The proposed study is a single center, open label parallel-group randomized control feasibility trial. Our study will control for the effect of treatment as usual in a community-based rheumatology clinic (i.e., medication and behaviour self-management). Patients will undergo baseline assessments and then will be randomized (1:1) to either the "small changes" BWLT or treatment as usual (TAU). The Small Changes BWLT is a cognitive-behavioural treatment program that was developed as an alternative to traditional behavioral therapy based on high treatment failure rates and weight regain across time - particularly in high-risk populations. Patients are provided with education on weight loss-promoting behaviour changes and encouraged to set SMALL [Self-selected, Measurable, Action-Oriented, Linked to your Life, and (Time) Limited] goals aimed at increasing self-efficacy and satisfaction, while decreasing feelings of deprivation in order to achieve sustained, long term weight loss in participants. The BWLT group will receive 16, weekly, 2-hour group-based sessions led by an undergraduate-level coach (i.e., BKin). Content covered includes nutrition, physical activity, mindfulness, cognitive restructuring, managing stress, sleep, social support, and problem-solving and is consistent with recent Canadian obesity treatment guidelines. The TAU group will received usual care from the Balfour community rheumatology clinic in Penticton, B.C. Feasibility metrics (i.e., drop-out/retention rates, patient adherence, patient-reported satisfaction with the BWLT etc.) will be assessed at the primary endpoint of 24-weeks post-randomization. Secondary outcomes (weight loss, PsA symptoms, HRQOL) will be
Impact/Future Directions: The results from the proposed study will be used to inform and develop a subsequent, adequately powered, randomized controlled efficacy trial investigating the primary outcome of weight-loss among patients with PsA and obesity who receive a BWLT, relative to TAU controls. Ultimately, the implementation of the BWLT to a community-based rheumatology clinic has potential to improve the quality of life in patients with PsA and comorbid obesity.
- Conditions
- Psoriatic Arthritis, Obesity
- Being tested
- BWLT, Waitlist Control for BWLT
- Keywords
- psoriatic arthritis, obesity, weight loss, behavioral intervention, small changes
- Medical subject headings
- Arthritis, Psoriatic, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BWLTBehavioural
This group will attend 16 2-hour group-based weekly sessions in Small Changes BWLT in addition to their treatment at the Balfour Medical Clinic
Waitlist Control for BWLTBehavioural
This group will receive treatment as usual at the Balfour Medical Clinic and put on a waitlist for the Small Changes BWLT program
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 16-week behavioural weight loss classes Receives: Behavioral: BWLT |
| Waitlist Control | Other | Participants in this arm will receive their treatment as usual for Psoriatic Arthritis and receive BWLT after the intervention group. Receives: Behavioral: Waitlist Control for BWLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability
Patients will be surveyed to asses satisfaction with the intervention in terms of: BWLT content, class duration, number of sessions, instructors, follow-up support etc.). Acceptability will be measured using a combination of Likert-style response questions and text analysis of open-field responses.
Measured: post-intervention (i.e., immediately following the final BWLT session at 24-weeks)
Intervention Feasibility (treatment adherence, Drop out/recruitment rates, protocol adherence)
Adherence to the intervention will be determined by chart review. Referral rates of eligible patients from the AF clinic will be recorded. Drop-outs will be recorded, including reasons for study drop-out if available. The clinical supervisor (Dr. Rouleau) will evaluate the interventionists' adherence to the BWLT manual and provide feedback as needed (e.g., regarding adherence to the manual, therapeutic/process skills).
Measured: post-intervention (i.e., immediately following the final BWLT session at 24-weeks)
Secondary outcomes (2)
Change in Weight
Patients will be weighed before and after the 12 week intervention and weight loss calculated in kilograms
Measured: baseline, post-intervention (i.e., immediately following the final BWLT session at 24-weeks)
Change in PsA symptom burden
PsA symptoms will be assessed using the EULAR Psoriatic Arthritis Impact of Disease: PsAID12 for clinical practice
Measured: Baseline, post-intervention (i.e., immediately following the final BWLT session at 24-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Feb 2022
- Primary completion22 Sep 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants of the Small Changes BWLT will attend 16 2-hour group-based weekly sessions (in a virtual format using Zoom teleconferencing). Sessions will be facilitated by a senior master's level interventionist rigorously trained in the program's delivery. The empirically validated ASPIRE BWLT will be adapted for a PsA population with obesity based on the results of a qualitative study that is currently underway. After the 16 weekly sessions are complete, patients will attend bi-weekly follow-up sessions for an additional 8-weeks via Zoom. Follow-up sessions will also be group-based. In total, patients will be provided 16+8 (24) group BWLT sessions across the treatment and follow-up period. Participants in the control group will continue to receive their treatment as usual from the Balfour Medical Clinic and be put on a waitlist for the BWLT. This group will receive the same treatment as the intervention group after the intervention group has received treatment.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tavis S. Campbell, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225623
- Sponsor's protocol ID
- REB21-2098
- Status last verified
- Dec 2023
- First submitted
- 6 Jan 2022
- Last updated
- 14 Dec 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 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Adaptation of the Small Changes Behavioural Weight Loss Treatment Approach for Psoriatic Arthritis Patients With Comorbid Obesity
- ClinicalTrials.gov ID
- NCT05225623
- Acronym / sponsor ID
- REB21-2098
- Conditions
- Psoriatic Arthritis, Obesity
- Keywords
- psoriatic arthritis, obesity, weight loss, behavioral intervention, small changes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 4 Feb 2022 (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.
Psoriatic Arthritis (PsA) is a type of auto-immune condition that affects roughly 90,000 Canadians. Patients with PsA often experience joint pain, skin problems, and issues with mobility that negatively impact their quality of life. Compared to the general population, patients with PsA are at a higher risk of having obesity (excess body weight). Although there is no cure for PsA, medications can be helpful for symptoms, and weight loss can provide an added benefit to the effectiveness of medications.
Behavioral weight loss treatment (BWLT) is a proven way to lose weight and keep it off. BWLT usually includes individual or group sessions with a health professional to learn strategies and tools to change behaviours and thoughts in order to support weight loss. However, few studies have designed a BWLT with the unique needs of patients with PsA in mind.
Before testing new treatments for chronic disease in large, expensive studies, it is important to do smaller-scale research to make sure that a future large study will be successful. In line with this, the objective of our study is to test the feasibility of a future, large study of a BWLT for patients with PsA and obesity. In other words, our small feasibility study will investigate how convenient, reasonable, and acceptable the future study's procedures are, using a small group of people with PsA and obesity.
People who have PsA and obesity will take either a special BWLT program, or receive usual care for PsA from a community-based rheumatologist. Those in the BWLT group will complete 16 online group sessions to help them learn cognitive and behavioral changes to help improve their health and manage weight. After 24 weeks, we will determine study completion rates, examine patient satisfaction, and assess whether the BWLT was provided to people as-designed. We believe this research will help with efforts to provide more effective treatments to patients with PsA to help them lose weight and improve their quality of life through reduced pain and symptoms.
Detailed description
Background: Psoriatic Arthritis (PsA) is an inflammatory auto-immune disorder that impacts approximately 3-in-10 patients with skin psoriasis. Compared to other rheumatologic conditions, patients with PsA are at a higher risk of having comorbid obesity (i.e., BMI ≥30 kg/m2; present in 44% of PsA cases). Treating patients with PsA and comorbid obesity presents a unique challenge due to added complications of attenuated pharmacological response to treatment, and mobility issues that impact quality of life for patients. While weight-loss is known to help alleviate symptom burden and improve quality of life in patients with PsA and comorbid obesity, few studies have investigated behavioural weight-loss treatment (BWLT) in patients with PsA to support sustained weight-loss over time.
Aims: The primary aim of the proposed trial will evaluate feasibility metrics (i.e., recruitment rate, drop-out, intervention fidelity, acceptability) of a randomized controlled clinical trial testing an adaptation of a validated "small changes"-based BWLT approach. The secondary aim is to examine differences in mean weight loss, self-reported PsA symptoms (e.g., pain, mobility) and health related quality of life (HRQOL) between patients randomized to BWLT versus patients in the control condition who receive treatment as usual (at a community-based rheumatology clinic).
Methods: The proposed study is a single center, open label parallel-group randomized control feasibility trial. Our study will control for the effect of treatment as usual in a community-based rheumatology clinic (i.e., medication and behaviour self-management). Patients will undergo baseline assessments and then will be randomized (1:1) to either the "small changes" BWLT or treatment as usual (TAU). The Small Changes BWLT is a cognitive-behavioural treatment program that was developed as an alternative to traditional behavioral therapy based on high treatment failure rates and weight regain across time - particularly in high-risk populations. Patients are provided with education on weight loss-promoting behaviour changes and encouraged to set SMALL [Self-selected, Measurable, Action-Oriented, Linked to your Life, and (Time) Limited] goals aimed at increasing self-efficacy and satisfaction, while decreasing feelings of deprivation in order to achieve sustained, long term weight loss in participants. The BWLT group will receive 16, weekly, 2-hour group-based sessions led by an undergraduate-level coach (i.e., BKin). Content covered includes nutrition, physical activity, mindfulness, cognitive restructuring, managing stress, sleep, social support, and problem-solving and is consistent with recent Canadian obesity treatment guidelines. The TAU group will received usual care from the Balfour community rheumatology clinic in Penticton, B.C. Feasibility metrics (i.e., drop-out/retention rates, patient adherence, patient-reported satisfaction with the BWLT etc.) will be assessed at the primary endpoint of 24-weeks post-randomization. Secondary outcomes (weight loss, PsA symptoms, HRQOL) will be
Impact/Future Directions: The results from the proposed study will be used to inform and develop a subsequent, adequately powered, randomized controlled efficacy trial investigating the primary outcome of weight-loss among patients with PsA and obesity who receive a BWLT, relative to TAU controls. Ultimately, the implementation of the BWLT to a community-based rheumatology clinic has potential to improve the quality of life in patients with PsA and comorbid obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants of the Small Changes BWLT will attend 16 2-hour group-based weekly sessions (in a virtual format using Zoom teleconferencing). Sessions will be facilitated by a senior master's level interventionist rigorously trained in the program's delivery. The empirically validated ASPIRE BWLT will be adapted for a PsA population with obesity based on the results of a qualitative study that is currently underway. After the 16 weekly sessions are complete, patients will attend bi-weekly follow-up sessions for an additional 8-weeks via Zoom. Follow-up sessions will also be group-based. In total, patients will be provided 16+8 (24) group BWLT sessions across the treatment and follow-up period. Participants in the control group will continue to receive their treatment as usual from the Balfour Medical Clinic and be put on a waitlist for the BWLT. This group will receive the same treatment as the intervention group after the intervention group has received treatment.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: BWLT16-week behavioural weight loss classes |
| Waitlist Control | Other | Behavioral: Waitlist Control for BWLTParticipants in this arm will receive their treatment as usual for Psoriatic Arthritis and receive BWLT after the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18+ years old,
- new or previous diagnosis of symptomatic psoriatic arthritis
- BMI ≥30kg/m2),
- willing to participate in a BWLT program,
- can speak and write in English to complete surveys,
Key exclusion criteria (5 listed)
- unstable ischemic cardiovascular disease
- severe pulmonary disease
- currently pregnant or breastfeeding
- active substance use disorder (drug or alcohol),
- currently participating in another structured weight-loss program
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 |
|---|---|---|
| BWLTThis group will attend 16 2-hour group-based weekly sessions in Small Changes BWLT in addition to their treatment at the Balfour Medical Clinic | Behavioural | Intervention |
| Waitlist Control for BWLTThis group will receive treatment as usual at the Balfour Medical Clinic and put on a waitlist for the Small Changes BWLT program | Behavioural | Waitlist Control |
Primary outcome
Intervention Acceptability
Time frame: post-intervention (i.e., immediately following the final BWLT session at 24-weeks)
Patients will be surveyed to asses satisfaction with the intervention in terms of: BWLT content, class duration, number of sessions, instructors, follow-up support etc.). Acceptability will be measured using a combination of Likert-style response questions and text analysis of open-field responses.
Intervention Feasibility (treatment adherence, Drop out/recruitment rates, protocol adherence)
Time frame: post-intervention (i.e., immediately following the final BWLT session at 24-weeks)
Adherence to the intervention will be determined by chart review. Referral rates of eligible patients from the AF clinic will be recorded. Drop-outs will be recorded, including reasons for study drop-out if available. The clinical supervisor (Dr. Rouleau) will evaluate the interventionists' adherence to the BWLT manual and provide feedback as needed (e.g., regarding adherence to the manual, therapeutic/process skills).
2 secondary outcomes
Change in Weight
Time frame: baseline, post-intervention (i.e., immediately following the final BWLT session at 24-weeks)
Change in PsA symptom burden
Time frame: Baseline, post-intervention (i.e., immediately following the final BWLT session at 24-weeks)
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 14 Dec 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 Phase 1 study testing BWLT in people with Psoriatic Arthritis and Obesity, run by University of Calgary 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 6 inclusion and 5 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 14 Dec 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Intervention Acceptability (time frame: post-intervention (i.e., immediately following the final BWLT session at 24-weeks)). 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 14 Dec 2023.