A Mixed Methods Pilot Randomized Controlled Trial of a Mobile Phone-based Health Program Among Adults With Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Change in Autonomous Motivation to Prevent T2DM
研究概览
简要总结
Type 2 diabetes mellitus (T2DM) can be prevented through weight loss and increased physical activity, yet its prevalence continues to rise. This trend may be due in part to low rates of participation in evidence-based lifestyle change programs such as the Diabetes Prevention Program (DPP). New strategies are needed to promote healthy behaviors among individuals at risk for T2DM, and mobile health technologies may be an effective and scalable approach to achieve this. One promising tool is JOOL Health, a mobile phone-based application that leverages principles from Self-Determination Theory to help individuals understand how certain behaviors (e.g. sleep, diet, physical activity) influence their ability to pursue their core values and purpose in life. Through personalized messaging and feedback, JOOL Health aims to increase autonomous motivation, a form of motivation closely associated with the initiation and maintenance of healthy behaviors.
In this mixed methods pilot randomized controlled trial, the investigators will test whether the JOOL Health mobile phone-based application -- used alone and in conjunction with other mobile health technologies to track weight and physical activity -- can increase autonomous motivation to prevent type 2 diabetes mellitus (T2DM) among individuals with prediabetes who previously declined participation in a Diabetes Prevention Program (DPP).
详细描述
This 12-week pilot randomized controlled trial aims to recruit 156 individuals with prediabetes who declined participation in a formal DPP despite invitation to participate at no out-of-pocket cost by their health plan. Participants will be randomized to 1 of 3 study arms: (1) a group that receives information on prediabetes, evidence-based strategies to decrease progression to diabetes, and a list of resources for mHealth tools for monitoring diet, physical activity, and weight (control group); (2) a group that receives the JOOL Health mobile phone application; and (3) a group that receives the JOOL Health mobile phone application and other mHealth tools (e.g. Fitbit activity tracker and wireless-enabled scale) whose results can be uploaded into JOOL.
The investigators will use a mixed methods approach with a sequential explanatory design, which is to say that quantitative data and qualitative data will be collected in 2 consecutive phases within the study. Specifically, in the first phase, investigators will collect and analyze qualitative data (e.g. focus groups) from a purposive sample of participants with differing levels of engagement and success. The rationale for this approach is that the quantitative data will provide a general overview of the intervention's efficacy and limitations, and the qualitative data will help to explain these findings by exploring participants' experiences and perspectives in more depth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Invited to participate in a DPP by the participant's health plan, but have not engaged in a program at least 6 months after receiving the first letter of invitation
- •Wireless internet access
- •Personal smartphone access
排除标准
- •Individuals currently participating in another lifestyle or behavior change program or research study
- •Inability to read, write, or speak English
- •Inability to provide informed consent
- •Women who are pregnant or intend to become pregnant during the intervention period
研究组 & 干预措施
Control
Participants in this group will receive information on prediabetes and evidence-based ways to decrease progression to diabetes as well as a list of resources for mHealth tools for monitoring diet, physical activity, and weight.
JOOL-Only
Participants in this group will receive information on prediabetes and evidence-based ways to decrease progression to diabetes, a list of resources for mHealth tools to monitor diet, physical activity and weight, and will receive the JOOL Health mobile phone application.
干预措施: JOOL Health Mobile Phone Application (Device)
JOOL-Plus
Participants in this group will receive information on prediabetes and evidence-based ways to decrease progression to diabetes, a list of resources for mHealth tools to monitor diet, physical activity and weight, the JOOL Health mobile phone application, a digital scale, and a Fitbit.
干预措施: JOOL Health Mobile Phone Application (Device)
结局指标
主要结局
Change in Autonomous Motivation to Prevent T2DM
时间窗: 12 Weeks
Change from baseline mean score on a scale of 1 - 7 as assessed by the Treatment Self Regulation Questionnaire- Autonomous Section survey instrument where 1 means little autonomous motivation and 7 means high autonomous motivation.
次要结局
- Change in psychosocial measures(Baseline to 12-week follow-up)
- Change in self-reported weight(Baseline to 12-week follow-up)
- Change in HbA1c(Baseline to 12-week follow-up)
研究者
Mary Ellen Michele Heisler
Dr. Michele Heisler, MD
University of Michigan