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临床试验/NCT02691260
NCT02691260已完成不适用

Incentivizing Behavior Change Skills to Promote Weight Loss

Duke University2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2016年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
2
主要终点
Weight Change From Baseline to 24 Weeks

研究概览

简要总结

The purpose of this study is to determine the feasibility of providing incentives to people enrolled in a weight-loss program for dietary self-monitoring and/or interim weight loss.

详细描述

In this study, community outpatients will participate in an effective, 24-week, low-carbohydrate weight loss program delivered via biweekly group classes. An innovative information technology (IT) solution will collate dietary self-monitoring data (input by patients via a mobile phone dietary application) and weight loss data (input by patients via remote scale). An algorithm will classify participants as achieving adequate or inadequate dietary self-monitoring and weight loss to earn intermittent rewards of varying value in real-time. Participants will be notified of earning rewards via text messaging.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • desire to lose weight;
  • agree to attend visits per protocol;
  • access to telephone and transportation;
  • English speaking;
  • able to complete study measures;
  • smart phone with data and texting plan;
  • body mass index 30 kg/m2 or greater

排除标准

  • pregnancy, breastfeeding, or lack of birth control if premenopausal
  • dementia, excessive alcohol use, or psychiatric illness
  • weight loss >4.5 kg in month prior to screening
  • weight > 380 lb (due to limit of cellular scale)
  • enrollment in other weight loss program
  • residing in nursing home or receiving home health care
  • unable to attend weight loss group at scheduled times
  • impaired hearing
  • medication other than metformin, incretin mimetics and incretin enhances for type 2 diabetes
  • unstable heart disease in 3 months prior to screening
  • furosemide 40 mg or higher (or equivalent)
  • chronic kidney disease
  • 2 or more errors on cognitive screener
  • blood pressure ≥160/100 mmHg

研究组 & 干预措施

no incentives

No Intervention

Participants do not receive financial incentives.

incentives for dietary self-monitoring

Active Comparator

Participants receive financial incentives for dietary self-monitoring.

干预措施: incentives for dietary self-monitoring (Behavioral)

incentives for interim weight loss

Active Comparator

Participants receive financial incentives for interim weight loss.

干预措施: incentives for interim weight loss (Behavioral)

incentives for both

Experimental

Participants receive incentives for dietary self-monitoring and interim weight loss.

干预措施: incentives for both (Behavioral)

结局指标

主要结局

Weight Change From Baseline to 24 Weeks

时间窗: 24 weeks

Measured in pounds

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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