Effectiveness of Integrative Intervention Strategies for Binge Eating in Patients With Overweight or Obesity: A Multidisciplinary Approach
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- objective BE episodes (OBEs)
研究概览
简要总结
The main goal of the clinical trial is to compare the short- and long-term outcomes of three 12-week interventions among outpatients with overweight/obesity and binge eating (BE):
- treatment-as-usual for weight loss (TAU);
- combined TAU and guided self-help for improving eating behaviors (TAU+GSH);
- combined TAU, GSH, and biofeedback (TAU+GSH+BF). The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs).
The secondary outcomes will be impulsivity, emotion dysregulation, interoceptive awareness, distress, physiological correlates of arousal (skin conductance and heart rate variability), and inflammatory biomarkers.
The TAU+GSH arm is expected to be comparable to the TAU+GSH+BF arm in reducing the number of days with OBEs but is expected to be significantly less effective in improving secondary outcomes (impulsivity, emotional dysregulation, interoceptive awareness, distress, physiological inflammatory markers). The TAU arm is expected to show significant inferiority regarding the primary and secondary outcomes and cost-effectiveness compared to the TAU+GSH and TAU+GSH+BF conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) age 18-65 years; (2) BMI≥25 kg/m2; (3) ability to read and write in Italian; (4) Binge Eating Disorder (BED) or subthreshold BED status.
排除标准
- •(1) current treatment for BE with a registered psychologist; (2) severe psychiatric disorders; (4) cognitive impairment; (5) pregnancy; (6) severe medical comorbidity.
结局指标
主要结局
objective BE episodes (OBEs)
时间窗: 12-week follow-up-1 4-month follow-up-2 (after the end-of-treatment)
The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs)
次要结局
- physiological correlates of arousal((T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment))
- psychological variables((T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment))
- inflammatory biomarkers((T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment))
研究者
CHIARA CONTI
Associate professor
G. d'Annunzio University