Implementing an Interdisciplinary Eating Disorder Screening and Treatment Program for Post-Bariatric Surgery Patients in Nova Scotia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Percentage of eligible patients who complete disordered eating screening at each timepoint.
研究概览
简要总结
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:
- Reach (how effectively the program engages the target population [post-weight loss surgery patients])
- Effectiveness (the extent of the program's impact on key clinical outcomes related to disordered eating and weight management)
- Adoption (the extent to which the program is adopted and accepted by clinicians)
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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).
排除标准
- 未提供
结局指标
主要结局
Percentage of eligible patients who complete disordered eating screening at each timepoint.
时间窗: 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.
Percentage of eligible patients (i.e., post-weight loss patients who are enrolled in the screening procedure) who complete the disordered eating screening measure (i.e., Loss of Control Over Eating Scale \[LOCES\]) at each timepoint (3-, 6-, 9-, 12-, 15-, and 18-month). To be calculated with the equation: \[Actual # of LOCES completed at a timepoint\] / \[Total # of eligible patients who could have completed LOCES at that timepoint\]
Screening Engagement Rate
时间窗: 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.
Percentage of eligible patients (i.e., post-weight loss patients who are enrolled in the screening procedure) who complete the disordered eating screening measure (i.e., Loss of Control Over Eating Scale \[LOCES\]) at each timepoint (3-, 6-, 9-, 12-, 15-, and 18-month). To be calculated with the equation: \[Actual # of LOCES completed at a timepoint\] / \[Total # of eligible patients who could have completed LOCES at that timepoint\]
次要结局
- Change in weight from baseline to post-treatment (Week 10).(From baseline to post-treatment (Week 10).)
- Change in weight from baseline to 1-month follow-up.(From baseline to 1-month follow-up (i.e., 1 month after Week 10).)
- Change in weight from baseline to 3-month follow-up.(From baseline to 3-month follow-up (i.e., 3 months after Week 10).)
- Frequency and outcomes of pharmacotherapy consultations for therapy non-responders.(From Week 4 to post-treatment (Week 10).)
- Proportion of therapy non-responders whose symptoms change following initiation of adjunctive pharmacotherapy.(From Week 4 to post-treatment (Week 10).)
- Percentage of eligible patients who initiate the screening procedure.(From 3- to 18-months post-weight loss surgery.)
- Change in weight from baseline to Week 4.(From baseline to Week 4.)
- Proportion of eligible patients who undergo a disordered eating diagnostic interview.(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.)
- Proportion of eligible patients who are diagnosed with disordered eating.(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.)
- Change in disordered eating psychopathology severity from baseline to Week 4.(From baseline to Week 4.)
- Change in disordered eating psychopathology severity from baseline to post-treatment (Week 10).(From baseline to post-treatment (Week 10).)
- Change in disordered eating psychopathology severity from baseline to 1-month follow-up.(From baseline to 1-month follow-up (i.e., 1 month after Week 10).)
- Change in disordered eating psychopathology severity from baseline to 3-month follow-up.(From baseline to 3-month follow-up (i.e., 3 months after Week 10).)
- Change in anxiety symptom severity from baseline to Week 4.(From baseline to Week 4.)
- Change in anxiety symptom severity from baseline to post-treatment (Week 10).(From baseline to post-treatment (Week 10).)
- Change in anxiety symptom severity from baseline to 1-month follow-up.(From baseline to 1-month follow-up (i.e., 1 month after Week 10).)
- Change in anxiety symptom severity from baseline to 3-month follow-up.(From baseline to 3-month follow-up (i.e., 3 months after Week 10).)
- Change in depression symptom severity from baseline to Week 4.(From baseline to Week 4.)
- Change in depression symptom severity from baseline to post-treatment (Week 10).(From baseline to post-treatment (Week 10).)
- Change in depression symptom severity from baseline to 1-month follow-up.(From baseline to 1-month follow-up (i.e., 1 month after Week 10).)
- Change in depression symptom severity from baseline to 3-month follow-up.(From baseline to 3-month follow-up (i.e., 3 months after Week 10).)
- Change in psychosocial impairment from baseline to Week 4.(From baseline to Week 4.)
- Change in psychosocial impairment from baseline to post-treatment (Week 10).(From baseline to post-treatment (Week 10).)
- Change in psychosocial impairment from baseline to 1-month follow-up.(From baseline to 1-month follow-up (i.e., 1 month after Week 10).)
- Change in psychosocial impairment from baseline to 3-month follow-up.(From baseline to 3-month follow-up (i.e., 3 months after Week 10).)
- Patient satisfaction with the TEAM-ED program.(At 3-month follow-up (i.e., 3 months after Week 10).)
- Change in disordered eating symptom frequency from baseline to post-treatment.(From baseline to post-treatment (Week 10).)
- Acceptability of the TEAM-ED program to clinicians.(At 12 and 18 months.)
- Screening Initiation Rate(From 3- to 18-months post-weight loss surgery.)
- Proportion of eligible patients who screen positive for loss of control eating.(From 3- to 18-months post-weight loss surgery.)
- Proportion of eligible patients who start disordered eating treatment.(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.)
- Treatment Non-Response Rate(From baseline (Week 1) to post-treatment (Week 10).)
- Treatment Completion Rate(From baseline to 3-month follow-up (i.e., 3 months after Week 10))
- Program Dropout Rate(From recruitment initiation (Month 0) to recruitment end (Month 24).)
- Adjunctive Pharmacotherapy Initiation Rate(From baseline to 3-month follow-up.)
研究者
Aaron Keshen
Psychiatrist and Co-director of the Nova Scotia Provincial Service for Eating Disorders
Nova Scotia Health Authority