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临床试验/NCT01830374
NCT01830374已完成不适用

Weight Suppression, Dieting, and Bulimia Nervosa: A Biobehavioral Study

Drexel University2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
132
试验地点
2
主要终点
Purging

研究概览

简要总结

The purpose of this study is to examine biological (e.g., energy expenditure, neuroendocrine and appetitive hormones)and behavioral (e.g., binge eating and purging) correlates of weight suppression and current dieting status in women with bulimia nervosa. The investigators have differentiated between a diet-induced long-term energy imbalance (weight suppression, or the difference between one's highest-ever body weight and current weight) and a short-term energy imbalance (current dieting to either lose weight or avoid weight gain). This study will elucidate how two common yet largely unexplored types of dieting influence biological and behavioral variables in patients with bulimia nervosa, which could lead to modifications of prevailing models of bulimia nervosa and new strategies for improving treatment outcome.

详细描述

Bulimia nervosa (BN) is a debilitating psychiatric disorder that primarily affects young women. Empirically supported treatments for BN have been identified but less than half of treated individuals achieve long-term remission from the disorder, possibly because current treatment approaches do not sufficiently account for variables that help maintain the disorder. Psychosocial models of BN emphasize the role of dieting as a proximal cause of binge eating and purging. Dieting has both psychological and biological facets but existing models of BN have overwhelmingly focused on its psychological impact. The investigators have differentiated between a diet-induced long-term energy imbalance (weight suppression (WS), or the difference between one's highest-ever body weight and current weight) and a short-term energy imbalance (current dieting to either lose weight or avoid weight gain). Recent research has shown that WS levels in BN are elevated and that degree of WS predicts the severity of various BN characteristics and its clinical course. Studies of current dieting (CD) to lose weight have found that it is associated with reduced binge eating in BN, a finding that conflicts with prevailing models of the disorder. The proposed research will examine biological (e.g., energy expenditure, neuroendocrine and appetitive hormones) and behavioral (e.g., binge eating and purging) correlates of WS and CD in those with BN. (Relatively few of those with BN report dieting to avoid weight gain but its biological and behavioral correlates will also be examined.) The project will recruit 132 women (66 at Drexel University and 66 at Columbia University) meeting provisional Diagnostic and Statistical Manual-V diagnostic criteria for BN. The investigators will test the hypotheses that 1) CD and elevated WS will be associated with alterations in biological indices of metabolism and appetite, 2) WS will predict greater binge eating and purging, and CD will predict less binge eating, measured using Ecological Momentary Assessment (EMA), and 3) higher real time ratings of daily food restriction intentions will predict a reduced probability of binge eating during the same day but an increased probability of binge eating in subsequent days. Assessments for all participants will include: weight and reported previous highest weight (to calculate WS), the Eating Disorders Examination, 14 days of EMA to assess food restriction intentions, binge eating and purging episodes, three 24-hr food recalls, and resting energy expenditure and metabolic and appetitive hormones (including complete thyroid panel, leptin, ghrelin, cortisol and estradiol). Participants will be asked to return 6 months later for follow-up assessments of weight. This study will elucidate how two common yet largely unexplored types of dieting influence biological and behavioral variables in patients with BN, which could lead to modifications of prevailing models of BN and new strategies for improving treatment outcome.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosis of bulimia nervosa according to the proposed DSM-V criteria
  • Either currently receiving eating disorder treatment or actively seeking treatment
  • BMI above 18.5 and below 30
  • Not experiencing any signs of menopause
  • Medically stable as determined by each site's study physician

排除标准

  • Change in pharmacological treatment over past 4 weeks
  • Currently taking atypical antipsychotic medications
  • History of anorexia nervosa within the past year
  • Pregnancy
  • Currently taking medications that could alter hormone levels or metabolism
  • Disorders affecting metabolism or hormone levels
  • Non-removal metallic object
  • Co-occurring severe mental illness
  • At risk for suicide

结局指标

主要结局

Purging

时间窗: 2 week EMA period

Number of purging episodes recorded over two weeks.

Hormone levels

时间窗: Site Visit 3 (2 weeks)

Hormone levels will be assessed approximately two weeks post-baseline at one time point.

Resting metabolic rate (RMR)

时间窗: Two weeks

RMR will be assessed at Site Visit 3, approximately two weeks post-baseline.

Total percent body fat

时间窗: Two weeks

Total percent body fat will be assessed at Site Visit 3 (approximately 2 weeks post-baseline) using dual energy x-ray absorptiometry.

Energy intake

时间窗: Three weeks

Energy intake (more specifically, energy density) will be assessed as an average of three dietary food recalls approximately three weeks post-baseline.

Binge Eating

时间窗: 2 week EMA period

Number of binge eating episodes over two week period.

次要结局

  • Psychosocial measures(Site Visit-Baseline)
  • Body weight(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Lowe

Professor

Drexel University

研究点 (2)

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