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临床试验/NCT03465306
NCT03465306已完成不适用

Developing and Validating Clinical Efficacy for Obesity Digital CBT Model

Seoul National University Hospital2 个研究点 分布在 2 个国家目标入组 70 人开始时间: 2017年9月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Change from Baseline

研究概览

简要总结

The aim of the present study is to develop and validate the effects of a new cognitive behavioral therapy (CBT) using digital healthcare mobile apps such as Noom Coach and InBody.

详细描述

Seventy female participants whose BMI scores were above 23 and who had no other clinical problem except obesity were randomized into an experimental and a control group. Forty-five people in the experimental group were connected with the therapist using digital healthcare apps, so they got daily feedbacks and assignments for 8 weeks. Twenty-five people in the control group also used digital healthcare apps but they were asked to do self-care without intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
19 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • SIMS score ranks over high 20% of total

排除标准

  • Had been prescribed with psychological problems or medical problems.

结局指标

主要结局

Change from Baseline

时间窗: Baseline, at 8 weeks, at 6 months

Weight difference

次要结局

  • Trait Anxiety Inventory (TAI)(Baseline, at 8 weeks, at 6 months)
  • the result of leptin(Baseline, at 8 weeks)
  • weight and height will be combined to report BMI in kg/m^2(Baseline, at 8 weeks, at 6 months)
  • Fat percent(Baseline, at 8 weeks, at 6 months)
  • Rosenberg Self-Esteem Scale (RSES). Child / Adolescent Measures(Baseline, at 8 weeks, at 6 months)
  • Dutch Eating Behavior Questionnaire (DEBQ)(Baseline, at 8 weeks, at 6 months)
  • the result of alanine aminotransferase (ALT)(Baseline, at 8 weeks)
  • Buffet index(Baseline, at 8 weeks)
  • Automatic Thoughts Questionnaire-30 (ATQ-30)(Baseline, at 8 weeks, at 6 months)
  • the result of triglycerides (TG)(Baseline, at 8 weeks)
  • the result of glucose(Baseline, at 8 weeks)
  • the result of insulin(Baseline, at 8 weeks)
  • the result of cholesterol total(Baseline, at 8 weeks)
  • the result of aspartate aminotransferase (AST)(Baseline, at 8 weeks)
  • Korean Beck Depression Inventory (K-BDI)(Baseline, at 8 weeks, at 6 months)
  • Body Shape Questionnaire: Psychometric properties of the short version (BSQ-8C)(Baseline, at 8 weeks, at 6 months)
  • Yale Food Addiction Scale (YFAS)(Baseline, at 8 weeks, at 6 months)
  • the result of gamma-glutamyl transferase (GGT)(Baseline, at 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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