Maintaining Resistance Training in Older Prediabetic Adults: Theoretical Approach

描述(申请人提供)：这项第二阶段临床试验的目的是证明基于社会认知理论(SCT)的干预措施在糖尿病前期(即糖耐量受损或空腹血糖受损)老年患者中启动并维持抵抗力训练以改善血糖稳态的有效性。总体目标与NIDDK的行为/预防研究计划关于个人、家庭和社区预防糖尿病及其并发症的战略是一致的。抵抗力训练特别适用于年长的糖尿病前期成年人，因为随着年龄的增长，瘦体重减少和糖耐量恶化。拟议的研究计划评估了一项为期15个月的基于SCT的干预措施，以维持老年人的抵抗力训练。50-69岁(N=220)糖尿病前期的男性和女性，被定义为表现出糖耐量受损(IGT；2-h葡萄糖140-199 mg/dl)或空腹血糖受损(IFG；100-125 mg/dl)，将首先遵循相同的标准，在监督下进行3个月的入门阶段和抵抗训练。所有完成初始阶段的人员将被随机分配到3种维护条件中的一种：1.基于SCT的长期、有抱负的干预，强调自我调节和其他SCT策略，以优化培训，接触褪色；2.长期通用干预，缺少许多SCT组件，但具有相同的褪色接触；或3.接触更少的标准干预。主要的结果指标是糖尿病前期指数(葡萄糖耐量和空腹血糖浓度)和强度。二次测量包括依从性、SS细胞反应性、胰岛素敏感性和处置指数，由口服葡萄糖和C肽最小模型确定；无脂肪质量，其他健康和代谢适宜性指标，以及SCT测量。评估将在基线、启动阶段结束时(3个月)、不同干预措施结束时(9个月)和所有接触结束后6个月(距基线15个月)进行。假设基于SCT的褪色接触阻力训练将产生比基于普通接触褪色接触的训练更好的结果，反过来，在9个月和15个月的评估中，基于标准的阻力训练将产生更好的结果。它还假设，通过坚持、自我效能和自我调节策略的使用，将通过坚持、自我效能和自我调节策略来改善葡萄糖稳态和阻力训练的力量。抵抗力训练已成为治疗和预防疾病和残疾的重要组成部分，尤其是对2型糖尿病。对公共卫生至关重要，NIDDK的一个重点是基于理论的干预措施，这种干预措施能够在启动阶段后在最少监督的情况下进行有效的长期耐药性培训，并通过理论构建促进遵守和结果的改善。公共卫生相关性：60-74岁的成年人中有一半以上患有糖尿病前期。抵抗(力量)训练似乎是除减肥和体力活动之外的另一种有效预防糖尿病前期的方式。尽管这些健康福利可以从有限的时间投资中积累起来，但在55岁以上的人中，只有10%-15%的人报告进行了任何强化活动。先前的工作表明，阻力训练(RT)可以在良好监督的环境中有效地启动，然而，很少有基于理论的研究表明在最少监督的环境中有效地维持RT。在缺乏这种基于理论基础的长期维持疗效研究的情况下，很可能尽管像糖尿病前期患者这样的人将启动RT，但很快就会有很高比例的人停止RT。因此，我们建议证明基于社会认知理论的干预在老年糖尿病前期患者中启动和维持RT以改善血糖稳态的有效性。

DESCRIPTION (provided by applicant): The aim of this Phase II Clinical Trial is to demonstrate the efficacy of social cognitive theory (SCT) based intervention for initiating, and most importantly, maintaining resistance training in older adults with pre-diabetes (i.e., impaired glucose tolerance or impaired fasting glucose) to improve glucose homeostatis. The overall aim is consistent with NIDDK's Behavioral/Prevetion Research Program's forcus on individual, family, and community-based strategies for prevention of diabetes and its complications. Resistance training is particularly applicable to older, prediabeteic adults given the loss of lean body mass and worsening of glucose tolerance with aging. The proposed research program evaluates a 15-month SCT based intervention for maintenance of resistance training with older adults. Men and women 50-69 (N=220) with pre-diabetes, defined as exhibiting either impaired glucose tolerance (IGT; 2-h glucose 140-199 mg/dl) or impaired fasting glucose (IFG; 100-125 mg/dl), will first follow the same standard, supervised 3-month initiation period with resistance training. All people completing the Initial Phase will be randomly assigned to 1 of 3 maintenance conditions: 1. a long-term SCT based, ASPIRE intervention, emphasizing self-regulation and other SCT strategies to optimize training, with faded contact; 2. a long-term Generic intervention lacking a number of SCT components but with the same faded contact, or, 3. a Standard intervention with more minimal contact. The primary outcome measures are indices of pre-diabetes (glucose tolerance and fasting glucose concentration) and strength. Secondary measures include adherence; ss-cell responsivity, insulin sensitivity, and disposition index, as determined by the oral glucose and C-peptide minimal model; fat free mass, other indicators of health and metabolic fitness, and SCT measures. Assessments will occur at baseline, at the end of the Initiation Phase (3 months), at the end of the different interventions (9 months) and 6 months after all contact has ended (15 months from baseline). It is hypothesized that SCT based resistance training with faded contact will produce better outcomes than Generic based training with faded contact, which in turn, will produce better outcomes than Standard-based resistance training at 9 month and 15 month assessments. It also is hypothesized that improvements in glucose homeostasis and in strength from resistance training will be mediated by adherence, self-efficacy, and use of self-regulation strategies. Resistance training has become an important component in the treatment and prevention of diseases and disabilites, and especially so for Type 2 diabetes. Critical to public health and a focus of NIDDK are theory-based interventions that enable, effective long-term resistance training with minimal supervision after an initiation phase and where improvements in adherence and outcomes are facilitated by theoretical constructs. PUBLIC HEALTH RELEVANCE: Pre-diabetes is present is more than half of adults aged 60-74 years. Resistance (strength) training appears to be another modality besides weight loss and physical activity that is effective for pre-diabetes prevention. Even though these health benefits can be accrued from a limited time investment, only 10-15 percent of people over 55 report performing any strengthening activities. Prior work suggests that resistance training (RT) can be effectively initiated in well-supervised settings, however there are very few theory-based studies showing effective maintenance of RT in minimally supervised settings. In the absence of such theoretically based efficacy studies on long-term maintenance, it is likely that although people such as those with pre-diabetes will initiate RT, a high percentage will soon discontinue RT. Therefore, we propose to demonstrate the efficacy of a social cognitive theory-based intervention for initiating and maintaining RT in older adults with pre-diabetes to improve glucose homeostasis.