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

摘要 背景技术背景：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，很难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，更好地为个人提供体验食物渴望和困难情绪的技能，而无需进食。这些方法寻求加强能力，以非判断性地意识到、容忍和熟练地应对食物渴望和困难情绪，而不会冲动地或不适应地做出反应。我们假设，改善对食物渴望和情绪化饮食的管理能力是正念增强可以改善饮食依从性的关键机制。我们将测试基于正念的干预（MBI）成分，以改善饮食依从性，这是基于我们小组最近NCCIH资助的测试MBI成分治疗肥胖的试验，该试验显示了改善空腹血糖，血脂和潜在体重的证据。虽然所采用的特定饮食不是本研究的重点，但我们计划使用约10%的卡路里来自碳水化合物的饮食，因为：（1）它诱导低水平的酮产生，我们将其用作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：我们将使用生态瞬时评估（EMA）方法来测量对困难情绪和/或食物渴望的反应。在R61阶段，我们将确保该措施适用于进一步测试和评估MBI组分对N=45例T2 DM患者的假设行为机制的影响。我们计划3波，每波15人，每周12次。所有参与者将参加一个面对面的小组课程，提供有关饮食和体育活动的基本行为策略的教育。受试者将随机接受单独的教育（艾德）或添加MBI组件的相同材料（艾德+MBI）。我们还将试点测试两个级别的维持阶段干预强度（每月单独举行小组会议或辅以个性化关注），为R33测试做好准备。我们计划进行一项R33期试验，其中120名T2 DM患者将随机（使用1：2的比例）接受艾德或艾德+MBI治疗，并随访12个月，包括9个月的维持期。我们将测试MBI组分对我们提出的行为机制和饮食依从性的影响，并获得MBI组分对体重和血糖控制影响的初步数据。我们将使用一种创新的适应性干预设计来优化维持阶段的强度，我们认为这可能是增强MBI效果的关键。重要性：我们的研究有望扩展我们对MBI成分如何改善饮食依从性的理解，并对理解MBI对其他疾病（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.