跳至主要内容
临床试验/NCT02891382
NCT02891382已完成不适用

Feasibility Study on the Impact of Economic Incentives for Weight Loss to Improve the Management of Type 2 Diabetes Mellitus: REDEEM Feasibility Study

Universidad Peruana Cayetano Heredia1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2016年7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
54
试验地点
1
主要终点
Change in Glycated Hemoglobin

研究概览

简要总结

This feasibility study aims to compare the implementation process of three different interventions that use economic incentives to promote lifestyle behavioral changes in patients with type 2 diabetes mellitus, and to identify barriers and facilitators linked to the process of implementing each of the interventions. The interventions are based on economic incentives directed to the patient (individual incentives) or a team comprised by the patient and a partner (mixed incentives).

Design: Three-month randomized control feasibility study to test the feasibility of implementing three types of intervention with economic incentives in patients with diabetes mellitus.

Setting: Diabetes outpatient clinics from a public hospital in Peru.

详细描述

Economic incentives have been used to promote changes in habits such as smoking and weight loss. However, no studies have been done to determine the impact of this strategy on the management of type 2 diabetes mellitus (T2DM). Additionally, previous studies do not describe ways to determine the amount of an economic incentive to promote behavioral changes, e.g adherence to treatment, increased physical activity and adherence to a healthy diet. There are also questions regarding the frequency of incentives, the type of incentive (cash or other prizes), and the preferred payment method that this study will allow us to explore. Furthermore, we want to test whether a "team work approach" (mixed incentives) vs. an "individual approach" (individual incentives) can also play a role in introducing behavioral changes.

The goal of the study is to learn about the implementation process of three different interventions that use economic incentives to promote behavioral changes in patients with T2DM, and identify main barriers and facilitators tied to the implementation process of each intervention.

This feasibility study will provide key insights to inform a future larger study; specifically, we will

  • Learn about the experience of participants with T2DM with economic incentives.
  • Learn about the experience of the companion/team support partners of the participants with T2DM.
  • Evaluate the patient's receptiveness to and comprehension of the educational materials used to promote behavioral changes.
  • Evaluate the patient and the companion/team support partner's receptiveness towards the received economic incentive as a tool for promoting behavioral changes.
  • Explore the companion/team support partner's activities that are most effective in helping with T2DM management of patients.
  • Explore whether patients with T2DM are able to keep a daily record of their efforts to manage their diabetes.
  • Evaluate the feasibility of packaging and implementing a future clinical trial that evaluates the impact of the use of economic incentives and teamwork in people with T2DM.

From a clinical perspective, we will evaluate the feasibility of reaching the proposed clinical goals in terms of weight loss and HbA1c levels after the intervention period.

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 (Investigator)

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Glycated Hemoglobin

时间窗: Baseline and 3 months

HbA1c change at 3 months from baseline

次要结局

  • Change in Weight(Baseline and 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验