Optimizing lifestyle interventions with mindfulness-based strategies in type 2 diabetes

摘要 背景：2型糖尿病(T2 DM)是美国最昂贵的慢性疾病。生活方式的改变是T2 DM管理的核心，但长期遵守饮食建议是困难的。一个关键的挑战是，在一个高碳水化合物或高糖食物诱人且随处可得的环境中，难以应对对这些食物的渴望。正念可以提高长期饮食依从性的一种机制是，更好地装备个人，让他们在不吃东西的情况下体验食物的渴望和艰难的情绪。这样的方法寻求加强能力，以非评判的意识，容忍，并巧妙地应对食物的渴望和困难的情绪，而不是冲动或不适应。我们假设，提高控制食物渴望和情绪化进食的能力是正念增强可以改善饮食依从性的关键机制。我们将根据我们小组最近由NCCIH资助的针对肥胖的基于正念的干预(MBI)成分的试验，测试基于正念的干预(MBI)成分，该试验显示出空腹血糖、血脂和潜在体重改善的证据。虽然所采用的特定饮食不是本研究的重点，但我们计划使用来自碳水化合物的约10%卡路里的饮食，因为：(1)它诱导低水平的酮产生，我们将使用它作为饮食依从性的生物标志物；(2)先前的研究表明，它改善了T2 DM的代谢参数，包括血糖控制。方法：我们将使用生态瞬间评估(EMA)方法来衡量饮食对困难情绪和/或食物渴望的反应。在R61阶段，我们将确保这一措施适用于进一步的测试，并评估MBI组件对我们在N=45名T2 DM患者中假设的行为机制的影响。我们计划3波15人，每周12次会议。所有参与者都将参加一个面对面的小组课程，提供关于饮食和体育活动的基本行为策略的教育。参与者将被随机分为单独接受这种教育(ED)或同样的材料加上MBI成分(ED+MBI)。我们还将试行两种水平的维护阶段干预(单独举行每月小组会议或辅之以个性化关注)，为R33测试做好准备。我们计划进行一项R33期试验，将120名T2 DM患者随机分为ED或ED+MBI组，并跟踪观察12个月，包括9个月的维持期。我们将测试MBI成分对我们提出的行为机制和饮食依从性的影响，并获得MBI成分对体重和血糖控制的初步数据。我们将使用创新的自适应干预设计来优化维护阶段的强度，我们认为这可能是增强MBI效果的关键。意义：我们的研究承诺扩大我们对MBI成分如何改善饮食依从性的理解，并对理解MBI在其他条件下(如成瘾)的机制具有更广泛的意义。

ABSTRACT BACKGROUND: Type 2 diabetes mellitus (T2DM) is the most expensive chronic disease in the U.S. Lifestyle modification is central to T2DM management, but long-term adherence to dietary recommendations is difficult. A key challenge is the difficulty of coping with cravings for high carbohydrate or sugar-laden foods in an environment where these foods are tempting and widely available. One mechanism by which mindfulness may increase long-term dietary adherence is by better equipping individuals with skills to experience food cravings and difficult emotions without eating in response. Such approaches seek to strengthen abilities to be non- judgmentally aware of, tolerate, and respond skillfully to food cravings and difficult emotions without reacting impulsively or maladaptively. We hypothesize that improved ability to manage food cravings and emotional eating is a key mechanism through which mindfulness-enhancements can improve dietary adherence. We will test mindfulness-based intervention (MBI) components for improving dietary adherence based on our group’s recent NCCIH-funded trial testing MBI components for obesity, which showed evidence of improved fasting glucose, lipids, and potentially weight. Although the particular diet employed is not the focus of this study, we plan to use a diet with about 10% of calories from carbohydrate as: (1) it induces a low level of ketone production, which we will use as a biomarker for dietary adherence; (2) prior studies suggest it improves metabolic parameters in T2DM, including glycemic control. METHODS: We will use ecological momentary assessment (EMA) methods to measure eating in response to difficult emotions and/or food cravings. In the R61 phase, we will ensure this measure is appropriate for further testing and assess the impact of the MBI components on our hypothesized behavioral mechanisms in N=45 persons with T2DM. We plan 3 waves of 15 persons each with 12 weekly sessions. All participants will attend an in-person group course providing education on basic behavioral strategies for diet and physical activity. Participants will be randomized to receive this education alone (Ed) or this same material with added MBI components (Ed+MBI). We will also pilot test two levels of intensity of maintenance phase intervention (monthly group meetings alone or supplemented by individualized attention) to prepare them for R33 testing. We plan an R33 phase trial in which 120 persons with T2DM will be randomized (using a 1:2 ratio) to Ed or Ed+MBI conditions and followed for 12 months, including a 9-month maintenance phase. We will test the effects of MBI components on our proposed behavioral mechanisms and dietary adherence, and obtain preliminary data on MBI component effects on weight and glycemic control. We will use an innovative adaptive intervention design to optimize maintenance phase intensity, which we believe may be key to augment the MBI effects. SIGNIFICANCE: Our studies promise to extend our understanding of how MBI components can improve dietary adherence and have broader implications for understanding the mechanisms of MBIs for other conditions such as addiction.