Using hunger training to enhance weight loss and modulate cancer-related biomarkers in women at high risk for breast cancer: a pilot study

摘要 研究表明，体重减轻> 10%有利于调节乳腺癌风险的生物标志物。的 最有效的行为减肥计划，如糖尿病预防计划（DPP）， 损失仅为4 - 7%。因此，许多人求助于减肥手术，这是昂贵的，激烈的， 通常不可逆转的选择，当成功时，导致体重减轻25 - 50%，远远超过 降低风险的必要条件。新的行为策略，增强现有的减肥成果 需要进行干预。最近采用的一项创新减肥战略是"饥饿训练"。 Hunger Training利用实时血糖监测作为生物反馈，帮助用户自我调节 开始进食以促进持续减肥，这可能对乳腺癌风险产生间接和直接影响 还原有证据表明，饥饿训练单独-没有任何额外的饮食限制或 增加身体活动-产生> 7%的体重减轻，并显著改善胰岛素敏感性。在 在拟议的试点研究中，我们将采用双臂方法，将联合收割机饥饿培训与DPP结合起来。我们将 随机选择50名非糖尿病绝经后肥胖妇女，确定为乳腺癌高危人群 并入组MD安德森纵向高风险乳腺队列≥ 1年，接受DPP 或DPP加饥饿训练16周。目的1是评估增加饥饿的可行性 向检察长提供培训。可行性标准将包括累积率> 50%，流失率<20%，以及方案 两个研究组的依从率> 75%。目的2是估计效应量的大小， 仅用发展伙伴关系和发展伙伴关系加饥饿培训干预措施的结果变量在 体重;代谢和乳腺癌风险生物标志物（例如，空腹胰岛素和葡萄糖水平， 糖化血红蛋白、胰岛素抵抗、脂联素、白细胞介素-6和C反应蛋白）; 行为介质（例如，减少总能量摄入，总体进食频率，进食事件百分比 发生在平均空腹血糖浓度或低于平均空腹血糖浓度）。这项研究将是第一个评估 在广泛传播的减肥干预措施中加入饥饿训练的协同效应。我们期望 发现在DPP中增加饥饿训练是可行的，并且联合干预具有 在有绝经后乳腺癌风险的肥胖妇女中，促进体重减轻> 10%的累加效应。 这项试点研究的成功完成将支持一项更大规模的随机对照试验， 此外，使我们能够比较DPP对减肥和减肥维持的长期影响， 这就是DPP+饥饿培训。

ABSTRACT Research has shown that a weight loss of >10% favorably modulates biomarkers of breast cancer risk. The most effective behavioral weight loss programs, such as the Diabetes Prevention Program (DPP), yield weight losses of only 4-7%. As a result, many people resort to weight-loss surgery, which is costly, drastic, and an often irreversible choice that, when successful, results in weight losses of 25-50%, which far exceed that necessary for risk reduction. New behavioral strategies that enhance the weight-loss outcomes of existing interventions are needed. One recently introduced and innovative weight-loss strategy is `Hunger Training'. Hunger Training uses real-time blood glucose monitoring as biological feedback to help users self-regulate meal initiation to promote sustained weight loss that may have indirect and direct effects on breast cancer risk reduction. Evidence demonstrates that Hunger Training alone—without any additional dietary restrictions or increased physical activity—produces weight losses of >7% and significantly improves insulin sensitivity. In the proposed pilot study, we will combine Hunger Training with the DPP using a two-arm approach. We will randomize 50 non-diabetic, postmenopausal obese women, identified as being at high risk for breast cancer and enrolled in the MD Anderson Longitudinal High Risk Breast Cohort for ≥1 year, to receive either the DPP only or the DPP-plus-Hunger Training for 16 weeks. Aim 1 is to evaluate the feasibility of adding Hunger Training to the DPP. Feasibility criteria will include accrual rates >50%, attrition rates <20%, and protocol adherence rates >75% for both study groups. Aim 2 is to estimate the magnitude of the effect sizes and variation in the outcome variables for the DPP-only and DPP-plus-Hunger Training interventions on changes in weight; metabolic and breast cancer risk biomarkers (e.g., fasting insulin and glucose levels, levels of glycosylated hemoglobin, insulin resistance, adiponectin, interleukin-6, and c-reactive protein); and proposed behavioral mediators (e.g., reduction in total energy intake, overall eating frequency, percent of eating events occurring at or below the average fasting blood glucose concentration). This study will be the first to assess the synergistic effect of adding Hunger Training to a highly disseminated weight-loss intervention. We expect to find that the addition of Hunger Training to the DPP is feasible and that the combined intervention has an additive effect on promoting weight losses of >10% in obese women at risk for postmenopausal breast cancer. The successful completion of this pilot study will support a larger randomized controlled trial that will additionally enable us to compare the DPP's long-term impact on weight loss and weight loss maintenance to that of the DPP-plus-Hunger Training.