A Randomised Controlled Trial of a New Integrated Approach to Management of Eating and Weight Disorders, Namely a Healthy APproach to weIght Management and Food in Eating Disorders Compared to Cognitive Behaviour Therapy Enhanced.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Sustained change weight (for less) of 5% of previous body weight. This is a level known to improve physical health (metabolic) outcomes.
研究概览
简要总结
The investigators have developed a new integrated therapy, namely a Healthy Approach to weIght management and Food in Eating Disorders (HAPIFED). HAPIFED is an enhanced behavioral weight loss therapy integrated with CBT for the management of EDs. HAPIFED uses CBT to treat ED behaviors and body image distress, whilst simultaneously emphasize a healthy lifestyle, the role of food and physical activity in mood regulation, and revised but clinically meaningful goals for weight loss. The investigators propose a randomized controlled trial (RCT) that will compare HAPIFED to CBT-E in people with obesity and either BN or BED. The two main aims will be to reduce symptoms of ED and to improve weight management. The RCT will be conducted in Sydney and in São Paulo with a one year follow-up.
详细描述
In sum, a new approach in management of the increasing numbers of obese people with BN and BED is needed. The investigators propose a RCT that will compare a novel therapy HAPIFED with the current 'gold-standard' trans diagnostic treatment, CBT-E. HAPIFED has been developed by the CIs and is based on recent developments in psychological approaches to obesity in general (as highlighted in Casazza et al.'s (2013) paper on "Myths, presumptions and facts about obesity") and in people with co-morbid obesity and BN or BED. Unlike CBT-E, it allows reduced energy intake and education around specific food choices - a necessary element in weight loss.
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
- Single (Participant)
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
- •Diagnosis of threshold or subthreshold for Bulimia Nervosa or Binge Eating Disorder (DSM-5/ICD-11)
- •BMI between ≥ 27 and < 40
排除标准
- •Diagnosis of psychosis, bipolar disorder or substance abuse dependence and/or a high level of suicide risk.
- •Use of weight loss medication or medications that interfere with appetite.
- •Cushing or Prader-Willi syndromes
- •History of bariatric surgery
- •Patients who are already in treatment
研究组 & 干预措施
HAPIFED
HAPIFED therapy
干预措施: HAPIFED (Behavioral)
CBT-E
CBT-E therapy
干预措施: CBT-E (Behavioral)
结局指标
主要结局
Sustained change weight (for less) of 5% of previous body weight. This is a level known to improve physical health (metabolic) outcomes.
时间窗: Baseline, 25-weeks (end) treatment, 6 and12 months follow-up.
Change of 5% of body weight.
次要结局
- Change in binge eating frequency(Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.)
- Severity of loss of control over eating(Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.)
- Improved metabolic indicators of weight management(Baseline, 25 weeks (end) treatment)
- Change in severity of binge eating(Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.)
- Change in the levels of depression, anxiety and stress.(Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.)
- Health related quality of life(Baseline, 14 weeks (mid) treatment, and 25 weeks (end) treatment, 6 and 12 months follow-up.)
研究者
ANGELICA CLAUDINO
Professor of Psychiatry
Federal University of São Paulo