Maintaining Resistance Training in Older Prediabetic Adults: Theoretical Approach

描述（由申请人提供）：本II期临床试验的目的是证明基于社会认知理论（SCT）的干预在糖尿病前期老年人（即，葡萄糖耐量受损或空腹葡萄糖受损）以改善葡萄糖稳态。总体目标与NIDDK的行为/预防研究计划的重点是预防糖尿病及其并发症的个人，家庭和社区为基础的战略是一致的。阻力训练特别适用于老年人，糖尿病前期的成年人，因为随着年龄的增长，瘦体重会减少，葡萄糖耐量会恶化。拟议的研究计划评估了一个15个月的SCT为基础的干预维持阻力训练与老年人。患有糖尿病前期的男性和女性50-69（N=220），定义为表现出葡萄糖耐量受损（IGT; 2-h葡萄糖140-199 mg/dl）或空腹葡萄糖受损（IFG; 100-125 mg/dl），将首先遵循相同的标准，监督3个月的抗阻训练起始期。所有完成初始阶段的人将被随机分配到3个维护条件之一：1。基于长期SCT的ASPIRE干预，强调自我调节和其他SCT策略，以优化培训，淡化接触; 2.长期的一般干预缺乏一些SCT组件，但具有相同的褪色接触，或，3. a标准干预，接触更少。主要结局指标是糖尿病前期（糖耐量和空腹血糖浓度）和强度指数。次要指标包括依从性; ss细胞反应性、胰岛素敏感性和处置指数，如通过口服葡萄糖和C肽最小模型确定的;去脂质量、健康和代谢适应性的其他指标以及SCT指标。将在基线、启动阶段结束时（3个月）、不同干预结束时（9个月）和所有联系结束后6个月（自基线起15个月）进行评估。假设在9个月和15个月的评估中，基于SCT的阻力训练和褪色接触将产生比基于通用的阻力训练和褪色接触更好的结果，而基于通用的阻力训练和褪色接触将产生比基于标准的阻力训练更好的结果。还假设，抵抗训练对葡萄糖稳态和力量的改善将通过坚持、自我效能和自我调节策略的使用来介导。阻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2型糖尿病。对公共卫生至关重要，NIDDK的重点是基于理论的干预措施，这些干预措施能够在初始阶段后进行有效的长期阻力训练，并在理论结构的促进下改善依从性和结果。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。阻力（力量）训练似乎是另一种形式，除了减肥和身体活动，是有效的预防糖尿病前期。尽管这些健康益处可以从有限的时间投资中获得，但55岁以上的人中只有10- 15%报告进行过任何强化活动。先前的工作表明，阻力训练（RT）可以在监督良好的环境中有效地启动，但很少有基于理论的研究表明在监督最少的环境中可以有效地维持RT。在没有这种基于理论的长期维持疗效研究，很可能，虽然人们，如糖尿病前期将启动RT，高比例将很快停止RT。因此，我们建议证明的疗效，社会认知理论为基础的干预启动和维持RT在老年人糖尿病前期，以改善葡萄糖稳态。

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.