mDiet: A Text Message Intervention for Weight Loss

描述（由申请人提供）： 我们提出了一项随机对照试验，以评估主要基于移动的手机发送的短信的减肥干预措施mDIET在21至60岁的超重和肥胖男性和女性中促进减肥和减肥维持的效果。这项研究是基于有前途的形成性研究和一项试点随机对照试验（RCT），最近在75名超重/肥胖男性和女性（平均年龄：49.9岁）中得出结论，并得到了NCI R21的支持。据我们所知，mDIET试点研究是第一个通过主要基于使用短信（SMS）的干预来解决超重/肥胖的RCT。在16周时，我们发现组间体重差异显著，mDIET使用者比对照组多减轻3.16%（2.88 kg），可接受性非常高。SMS消息收发正变得越来越普遍，并且基本上可以在所有移动的电话平台上查看。因此，使用这种方法的行为干预的人群范围可以是广泛的。在这个项目中，我们将扩展和加强mDIET的专家系统逻辑，加强针对有助于减肥的能量摄入行为的内容，并开发与体力活动和久坐行为相关的额外内容-所有这些变化都旨在使mDIET能够促进和维持12个月内5-10%的体重减轻。我们将在那些第一语言是西班牙语的人中进行额外的形成性研究，并为讲英语和西班牙语的男性和女性开发mDIET。然后，309名超重/肥胖（BMI 25.1-39.9）的女性和男性，年龄21-60岁，将被随机分配到三个12个月的条件之一：a）仅SMS版本的mDIET; B）SMS+电话版本的mDIET，包括来自训练有素的减肥专家的定期简短咨询电话;或c）基于常规护理标准打印的体重干预。我们将在西班牙语偏好组中招募约30%的受试者，以确保我们能够在该人群中进行有意义的探索性分析。mDIET基于行为理论，并且可以支持向每个用户递送定制的消息。主要结局将是mDIET对12个月时体重减轻百分比的影响。次要结果将包括在6个月和12个月时评估mDIET对每组的比例的影响，这些比例至少减轻了5%的初始体重、行为和心理社会结构、生活质量和抑郁、对干预的满意度以及与使用干预元素相关的过程测量。

DESCRIPTION (provided by applicant): We propose a randomized controlled trial to evaluate how well a weight loss intervention based primarily on text messages sent to/from mobile phones, mDIET, promotes weight loss and weight loss maintenance in overweight and obese men and women age 21 through 60. This study is based on promising formative research and a pilot randomized controlled trial (RCT) recently concluded among 75 overweight/obese men and women (mean age: 49.9) with the support of an NCI R21. To our knowledge the mDIET pilot study was the first RCT to address overweight/obesity with an intervention that is based primarily on the use of text (SMS) messages. At 16 weeks we found a significant between-group difference in weight with mDIET users losing 3.16% more weight (2.88 kg) than controls and very high acceptability. SMS messaging is becoming increasingly common and can be viewed on essentially all mobile phone platforms. Thus, the population reach of behavioral interventions using this approach can be extensive. In this project we will expand and strengthen the expert system logic underlying mDIET, strengthen content targeted at energy intake behaviors that contribute to weight loss and develop additional content related to physical activity and sedentary behavior -- all changes aimed at enabling mDIET to promote and sustain a 5-10% weight loss at 12 months. We will conduct additional formative research among those whose first language is Spanish, and develop mDIET for both English and Spanish-language speaking men and women. Then, 309 overweight/obese (BMI 25.1-39.9) women and men, age 21-60 will be randomized to one of three 12-month conditions: a) an SMS only version of mDIET; b) An SMS+Phone version of mDIET that includes regular brief counseling calls from a trained weight loss specialist; or c) a usual care Standard Print-based weight intervention. We will enroll approximately 30% in the Spanish language preference group to assure our ability to perform meaningful exploratory analyses in this population. mDIET is based in behavioral theory and can support delivery of tailored messages to each user. The primary outcome will be the effect of mDIET on percent weight loss at 12 months. Secondary outcomes will include assessments at 6 and 12 months of mDIET effects on proportion of each group that lose at least 5% of initial body weight, behavioral, and psychosocial constructs, quality of life & depression, satisfaction with the intervention and process measures related to use of intervention elements.