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记物。这个 最有效的行为减肥计划，如糖尿病预防计划(DPP)，可以产生体重 损失只有4-7%。因此，许多人求助于减肥手术，这是昂贵的，剧烈的，和 通常是不可逆转的选择，如果成功，体重会减少25%-50%，远远超过 对于降低风险来说是必要的。新的行为策略，提高现有的减肥效果 干预是必要的。最近推出的一种创新的减肥战略是“饥饿训练”。 饥饿训练使用实时血糖监测作为生物反馈，帮助用户自我调节 开始进餐促进持续减肥，这可能对乳腺癌风险有间接和直接影响 还原。有证据表明，单独的饥饿训练--没有任何额外的饮食限制或 增加体力活动-使体重减轻7%，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饥饿培训与民进党相结合。我们会 随机选择50名绝经后肥胖的非糖尿病女性，这些女性被确认为乳腺癌高危人群 并参加了MD Anderson纵向高危乳房队列，为期1年，以获得≥ 只有民进党加饥饿训练，为期16周。目标1是评估添加饥饿的可行性 对民进党的培训。可行性标准将包括应计率&50%、流失率&20%和协议 两个研究组的依从率均为75%。目标2是估计影响的大小和大小 仅DPP和DPP加饥饿训练干预措施的结果变量的变化 体重；代谢和乳腺癌风险生物标记物(例如，空腹胰岛素和血糖水平， 糖化血红蛋白、胰岛素抵抗、脂联素、白介素6和C反应蛋白)；并建议 行为调节因素(例如，总能量摄入量的减少、总体进食频率、进食事件的百分比 发生在平均空腹血糖浓度或以下的)。这项研究将是第一次评估 在高度传播的减肥干预措施中加入饥饿训练的协同效应。我们希望 发现民进党增加饥饿训练是可行的，联合干预有 在有绝经后乳腺癌风险的肥胖女性中促进体重减轻10%的相加效应。 这项先导研究的成功完成将支持一项更大的随机对照试验，该试验将 此外，使我们能够将民进党在减肥和减肥维持方面的长期影响与 民进党加饥饿培训。

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.