Clinical trial NCT06914219: Implementing an Interdisciplinary Eating Disorder Screening and Treatment Program for Post-Bariatric Surgery Patients in Nova Scotia
Official title: Implementing an Interdisciplinary Eating Disorder Screening and Treatment Program for Post-Bariatric Surgery Patients in Nova Scotia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bariatric Surgery Patients
Disordered Eating Behaviors
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Queen Elizabeth II Health Sciences Centre Foundation
First posted: 2025-04-06
Enrollment: 250
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this interventional study is to evaluate the Treatment and Evaluation for After Metabolic Surgery with Eating Disorders (TEAM-ED) program, which is a combined screening and treatment program for managing disordered eating in adults who have recently had weight loss surgery in Nova Scotia. The main question it aims to answer is 'can an interdisciplinary program for screening, diagnosing, and treating disordered eating after weight loss surgery be implemented in Nova Scotia?

This study will determine the feasibility and impact of the TEAM-ED program by assessing the following objectives:

1. Reach (how effectively the program engages the target population \[post-weight loss surgery patients\])
2. Effectiveness (the extent of the program's impact on key clinical outcomes related to disordered eating and weight management)
3. Adoption (the extent to which the program is adopted and accepted by clinicians)
4. Implementation (how consistent program delivery is and factors impacting consistent delivery)

Participants will complete a disordered eating screening questionnaire online every 3 months after weight loss surgery until they reach 18-months post-surgery. Participants found to have disordered eating will be offered TEAM-ED treatment (Cognitive Behavioral Therapy, and treatment plan oversight by both weight loss surgery and eating disorder specialists). Standard outcome measures will be collected at baseline, during eating disorder treatment, post-treatment, and at follow-ups. Participants may also be asked to do a one-on-one research interview about their experiences with the program.


Eligibility criteria: Inclusion Criteria:

* ≥19 years old
* Between 3- and 18-months post-weight loss surgery.
* Able to complete English computer-based self-report questionnaires (with adequate accommodation, if necessary).

Primary outcomes:
measure: Percentage of eligible patients who complete disordered eating screening at each timepoint.
timeFrame: From the post-weight loss surgery timepoint when a participant is first enrolled in the screening procedure (3-, 6-, 9-, 12-, 15-, or 18-months) until 18-months post-surgery or until they screen positive for disordered eating.
Secondary outcomes:
measure: Proportion of eligible patients who undergo a disordered eating diagnostic interview.
timeFrame: From the post-weight loss surgery timepoint when a participant is first enrolled in the screening procedure (3-, 6-, 9-, 12-, 15-, or 18-months) until they screen positive for disordered eating.
measure: Proportion of eligible patients who are diagnosed with disordered eating.
timeFrame: From the post-weight loss surgery timepoint when a participant is first enrolled in the screening procedure (3-, 6-, 9-, 12-, 15-, or 18-months) until they screen positive for disordered eating.
measure: Change in disordered eating symptom frequency from baseline to post-treatment.
timeFrame: From baseline to post-treatment (Week 10).
measure: Change in disordered eating psychopathology severity from baseline to Week 4.
timeFrame: From baseline to Week 4.
measure: Change in disordered eating psychopathology severity from baseline to post-treatment (Week 10).
timeFrame: From baseline to post-treatment (Week 10).
measure: Change in disordered eating psychopathology severity from baseline to 1-month follow-up.
timeFrame: From baseline to 1-month follow-up (i.e., 1 month after Week 10).
measure: Change in disordered eating psychopathology severity from baseline to 3-month follow-up.
timeFrame: From baseline to 3-month follow-up (i.e., 3 months after Week 10).
measure: Change in anxiety symptom severity from baseline to Week 4.
timeFrame: From baseline to Week 4.
measure: Change in anxiety symptom severity from baseline to post-treatment (Week 10).
timeFrame: From baseline to post-treatment (Week 10).
measure: Change in anxiety symptom severity from baseline to 1-month follow-up.
timeFrame: From baseline to 1-month follow-up (i.e., 1 month after Week 10).
measure: Change in anxiety symptom severity from baseline to 3-month follow-up.
timeFrame: From baseline to 3-month follow-up (i.e., 3 months after Week 10).
measure: Change in depression symptom severity from baseline to Week 4.
timeFrame: From baseline to Week 4.
measure: Change in depression symptom severity from baseline to post-treatment (Week 10).
timeFrame: From baseline to post-treatment (Week 10).
measure: Change in depression symptom severity from baseline to 1-month follow-up.
timeFrame: From baseline to 1-month follow-up (i.e., 1 month after Week 10).
measure: Change in depression symptom severity from baseline to 3-month follow-up.
timeFrame: From baseline to 3-month follow-up (i.e., 3 months after Week 10).
measure: Change in psychosocial impairment from baseline to Week 4.
timeFrame: From baseline to Week 4.
measure: Change in psychosocial impairment from baseline to post-treatment (Week 10).
timeFrame: From baseline to post-treatment (Week 10).
measure: Change in psychosocial impairment from baseline to 1-month follow-up.
timeFrame: From baseline to 1-month follow-up (i.e., 1 month after Week 10).
measure: Change in psychosocial impairment from baseline to 3-month follow-up.
timeFrame: From baseline to 3-month follow-up (i.e., 3 months after Week 10).
measure: Change in weight from baseline to Week 4.
timeFrame: From baseline to Week 4.
measure: Change in weight from baseline to post-treatment (Week 10).
timeFrame: From baseline to post-treatment (Week 10).
measure: Change in weight from baseline to 1-month follow-up.
timeFrame: From baseline to 1-month follow-up (i.e., 1 month after Week 10).
measure: Change in weight from baseline to 3-month follow-up.
timeFrame: From baseline to 3-month follow-up (i.e., 3 months after Week 10).
measure: Proportion of therapy non-responders whose symptoms change following initiation of adjunctive pharmacotherapy.
timeFrame: From Week 4 to post-treatment (Week 10).
measure: Percentage of eligible patients who initiate the screening procedure.
timeFrame: From 3- to 18-months post-weight loss surgery.
measure: Acceptability of the TEAM-ED program to clinicians.
timeFrame: At 12 and 18 months.
measure: Frequency and outcomes of pharmacotherapy consultations for therapy non-responders.
timeFrame: From Week 4 to post-treatment (Week 10).
measure: Patient satisfaction with the TEAM-ED program.
timeFrame: At 3-month follow-up (i.e., 3 months after Week 10).
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Abbie J Lane Memorial Building, QEII Health Sciences Centre, Nova Scotia Health Authority
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Aaron Keshen, MD
role: PRINCIPAL_INVESTIGATOR
References: