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ENGAGED: E-Networks Guiding Adherence to Goals for Exercise and Diet (ENGAGED)

2016年11月10日 更新者：Bonnie Spring、Northwestern University
The ENGAGED study is a 12-month randomized controlled trial investigating different strategies to improve weight loss in overweight individuals. All participants will receive an effective weight loss treatment: either self-guided or group formats. All treatment will be provided in the Department of Preventive Medicine at Northwestern University. Participants who receive the self-guided weight loss treatment will be provided with a weight loss manual that contains proven behavioral weight loss strategies. Those participants who receive the group treatment will take part in 8 weekly, 90 minute group sessions in our clinic at 680 N. Lakeshore Dr., Chicago, IL 60048. Some participants will also be assigned an individual coach, who will communicate with them regularly via phone, email, and/or text message for the duration of the study. All participants must be willing and able to record food and beverage intake (either on a smartphone or on paper) and be willing to wear a small and unobtrusive physical activity measurement device for the first six-months of the study. Additionally, all participants will be asked to attend 3 follow-up assessment visits at our clinic at months 3, 6 and 12 after the study begins. Participants will be compensated for completing each of the 3 follow-up assessments. All participants will be part of a team weight loss competition at 3 and 6 months with financial incentive to be split evenly among the winning team.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The Diabetes Prevention Program (DPP) intensive lifestyle intervention is the gold standard weight loss treatment for adults with cardiometabolic risk factors. Despite its efficacy, the DPP has not been widely adopted, because its 16 individual, face-to-face sessions with a specialist are considered too burdensome and expensive to be a sustainable program. Attempts to reduce cost by decreasing session number have yielded greatly diminished weight loss. Behavioral adherence to diet and activity goals declines and weight regain routinely begins once frequent face-to-face meetings cease. The still unmet challenge of DPP implementation is how to reduce treatment intensity without excising the regular social support, accountability, and feedback that are essential to maintain adherence. We hypothesize that it is feasible to implement DPP Intensive Lifestyle Treatment as effectively but twice as efficiently by using hand held technology to preserve feedback, accountability, and regular social support. The smartphone-based technology system to be tested is guided by Carver and Scheier's control systems theory of self-regulation. Initial formative research will upgrade the smartphone with engaging features that motivate participants to use the device to self-monitor and interact with a coach and peer support group. Use of the finalized tool will be compared to usual recording on paper records in a preliminary 3-group randomized controlled trial (RCT) involving 96 obese adults. By enabling peer support, accountability, and feedback on diet, physical activity, and weight loss goals continuously through the 6-month intervention period, the ENGAGED system is expected to enhance (1) behavioral adherence [operationalized by (a) self-monitoring of diet and activity and (b) attainment of diet and activity goals], and (2) weight loss. An enabling technology that integrates specialist and peer support resources to improve treatment adherence could help to curtail the obesity epidemic by increasing the efficiency, feasibility, and reach of effective DPP lifestyle intervention.

研究类型

介入性

注册 (实际的)

96

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Illinois
      • Chicago、Illinois、美国、60611
        • Northwestern University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • BMI between 30-40
  • weight stable (not gained/lost more than 25 lbs in the past 6 months)
  • not enrolled in any formal weight-loss program
  • interested in losing weight
  • willing and able to record dietary intake and weight for 6 months and wear an accelerometer
  • willing to attend 8 weekly groups and 2 follow up assessments at the Northwestern Chicago campus
  • expect to reside in the Chicago land area for the next 12 months

Exclusion Criteria:

  • any unstable medical conditions (i.e. uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, a cerebrovascular accident within the past 6 months)
  • history of insulin-dependent diabetes
  • Crohn's disease
  • diagnosis of obstructive sleep apnea requiring intervention
  • required use of an assistive device for mobility (i.e. cane, wheelchair)
  • BMI > 40
  • hospitalization for a psychiatric disorder within the past 5 years
  • those at risk for adverse cardiovascular events with moderate intensity activity
  • those currently taking weight loss medication or committed to following an incompatible dietary regimen
  • women who are pregnant, trying to get pregnant, or lactating
  • Bulimia Nervosa
  • suicide ideation
  • current binge eating disorder
  • those currently taking medications known to cause weight gain (i.e. Prednisone, Depakote, Diebeta, Diabinese, Cardura, Inderal, Zyprexa)
  • current substance abuse or dependence
  • plantar fasciitis
  • current substance and/or alcohol dependence
  • depression
  • ADHD

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：阶乘赋值
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Standard
Those randomized to the Standard condition will record everything they eat and will total their daily fat grams and calories on the "Keeping Track" form used in the DPP. They will turn in their self-monitoring diaries and download their accelerometer (but not see those data) at weekly group sessions 1 through 8. Thereafter they will be expected to turn in paper data monthly, in person at the months 3 and 6 assessments and via mail, fax or e-mail for months 4 and 5. Accelerometer data will be downloaded at in-person visits.
行为的：Standard
Those randomized to the Standard condition will record everything they eat and will total their daily fat grams and calories on the "Keeping Track" form used in the DPP. They will turn in their self-monitoring diaries and download their accelerometer (but not see those data) at weekly group sessions 1 through 8. Thereafter they will be expected to turn in paper data monthly, in person at the months 3 and 6 assessments and via mail, fax or e-mail for months 4 and 5. Accelerometer data will be downloaded at in-person visits.
实验性的：Technology Supported condition
Those randomized to the Technology Supported condition will record dietary intake and weight on the smartphone, using the user-friendly, persuasive interface developed in Phase I. They will be expected to enter their dietary intake into the smartphone daily throughout the day. They will also be expected to enter their weight and to wear the accelerometer daily. Time-stamped data from the smartphone will upload automatically to the study server throughout the day, where it will be visible to the lifestyle coach. The participant's real-time diet, activity, and weight data relative to goals will also be visually depicted on the participant's smartphone. The anticipated web platform will be developed specifically for the ENGAGED participants. The coach will provide feedback on diet and activity self-monitoring and goal adherence at least weekly by phone, e-mail or text during weeks 1-8 and then at least monthly through the 6 month follow-up.
行为的：Technology Supported
Those randomized to the Technology Supported condition will record dietary intake and weight on the smartphone, using the user-friendly, persuasive interface developed in Phase I. They will be expected to enter their dietary intake into the smartphone daily throughout the day. They will also be expected to enter their weight and to wear the accelerometer daily. Time-stamped data from the smartphone will upload automatically to the study server throughout the day, where it will be visible to the lifestyle coach. The participant's real-time diet, activity, and weight data relative to goals will also be visually depicted on the participant's smartphone. The anticipated web platform will be developed specifically for the ENGAGED participants. The coach will provide feedback on diet and activity self-monitoring and goal adherence at least weekly by phone, e-mail or text during weeks 1-8 and then at least monthly through the 6 month follow-up.
无干预：Self-Guided
Participants in the Self-Guided condition will receive DPP DVDs (3 DVDs and 1 CD) at the beginning of the study. This condition will not receive any direct dietary or physical activity interventions outside of the DVDs. Although Self-Guided participants will be receiving the same 7% weight loss goal as the other two groups, they will not be receiving physical activity or diet goals. The DVDs cover the initial 12-weekly sessions of the DPP, with the sessions portrayed by professional actors. They will also be provided with a supplemental DVD which includes a manual for each of the 12 sessions. They will also be giving the Keeping Track booklets and asked to record their diet and activity daily.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Weight loss
大体时间：3 months, 6 months, 12 months
3 months, 6 months, 12 months

次要结果测量

结果测量
大体时间
Behavioral adherence
大体时间：3 months, 6 months
3 months, 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Northwestern University

合作者

Illinois Institute of Technology

调查人员

  • 首席研究员：Bonnie Spring, Ph.D.、Northwestern University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年7月1日

初级完成 (实际的)

2013年5月1日

研究完成 (实际的)

2013年5月1日

研究注册日期

首次提交

2010年1月15日

首先提交符合 QC 标准的

2010年1月15日

首次发布 (估计)

2010年1月18日

研究记录更新

最后更新发布 (估计)

2016年11月11日

上次提交的符合 QC 标准的更新

2016年11月10日

最后验证

2016年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • RC1DK087126-01 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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