跳至主要内容
临床试验/NCT03386006
NCT03386006已完成不适用

Randomized Trial of an Innovative Smartphone Application for Bariatric Surgery

Noom Inc.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Noom Inc.
入组人数
50
试验地点
1
主要终点
Change in adherence to dietary recommendations

研究概览

简要总结

The prevalence of overweight in America is a national public health crisis. As more people consider bariatric surgery for the treatment of severe obesity, it is imperative to identify factors influencing surgical outcomes. Technology, particularly the Noom Coach platform, offers a unique opportunity to improve standard interventions utilized in bariatric surgery programs. This study plans to test the efficacy of the Noom Coach platform on patients' adherence behaviors and psychosocial factors compared to standard care.

详细描述

Overweight and obesity have reached epidemic proportions in the United States. Few behavioral treatments are effective for overweight, and bariatric surgery is consequently an increasingly important option. Although these procedures produce significantly more weight change than psychosocial treatments, post-operative weight losses vary widely, about 20% of patients clearly experience suboptimal weight loss, and a notable subset of these patients demonstrate substantial weight regain. Further, 20-30% report persistence of disturbed eating, depression or anxiety, or impaired health related quality of life. Adherence, or "the extent to which a person's behavior coincides with medical or health advice," contributes to variable weight and psychosocial outcomes, as well as failure to follow dietary guidelines, each of which negatively impacts weight loss.

The present study, utilizing "Noom Coach for Bariatric Health", offers a unique opportunity to overcome obstacles to providing empirically supported treatments and to improve standard interventions utilized in bariatric surgery programs; however, rigorous research on apps is limited, and high-quality, adequately powered, randomized controlled trials with large samples are required. The project will therefore test a combined smartphone app and health coaching system to improve adherence and behavioral outcomes for patients receiving bariatric surgery.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Enrolled in: the Mount Sinai Bariatric Surgery Program and planning to receive a bariatric procedure.
  • Between the ages of 18 and 60 at entry to the study.
  • Speak English.

排除标准

  • Clinically significant cognitive limitations or history of developmental disability.
  • History of neurological disorder or injury.
  • Current/lifetime Diagnostic and Statistical Manual of Mental Disorders (DSM-5) serious psychiatric disorder, such as bipolar disorder, schizophrenia, or psychotic disorder.
  • Acute suicide risk.
  • Current DSM-5 alcohol or substance use disorder.
  • Pregnancy.

结局指标

主要结局

Change in adherence to dietary recommendations

时间窗: Baseline and 8 weeks

Change in adherence to recommendations provided within pre-bariatric surgery program will be assessed using the ASA-24 interview. The interview is a 24-hr recall of all food and drink consumed. This interview will serve as the basis for measuring the adherence to dietary recommendations.

Change in adherence to physical activity recommendations (IPAQ)

时间窗: Baseline and 8 weeks

Change in adherence to physical activity recommendations will also be measured using self reported physical activity using the International Physical Activity Questionnaire (IPAQ) The IPAQ is a 27- item questionnaire that assesses physical activity over the past week as a part of everyday activity, activity as a part of work, and activity as recreation. Scores include both minutes and days spent doing physical activity with higher scores indicating more time spent doing these activities. The measure can be scored categorically (low, moderate, high) or continuously using a defined scoring protocol.

Change in adherence to physical activity recommendations (Activity Tracker)

时间窗: Ongoing

Change in adherence to physical activity recommendations will be measured using information collected from each participants activity tracker (FitBit). The activity tracker records number of steps taken each day and any physical activity performed.

次要结局

  • Depression Anxiety Stress Scales (DASS)(Baseline and 8 weeks)
  • Eating Disorder Examination Questionnaire (EDE-Q)(Baseline and 8 weeks)
  • Short Form-36 Health Survey (SF-36)(Baseline and 8 weeks)

研究者

发起方
Noom Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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