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

使用饥饿训练来增强乳腺癌高危女性的减肥效果并调节癌症相关生物标志物：一项试点研究

基本信息

批准号：
9543401
负责人：
KAREN M BASEN-ENGQUIST
金额：
$ 17.4万
依托单位：
UNIVERSITY OF TX MD ANDERSON CAN CTR
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-08-11 至 2020-07-31
项目状态：
已结题

项目摘要

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.

抽象的研究表明，体重减轻 >10% 有利于调节乳腺癌风险的生物标志物。最有效的行为减肥计划，例如糖尿病预防计划（DPP）、增重仅仅损失了 4-7%，因此，许多人采取了昂贵、剧烈且效果显着的减肥手术。通常是不可逆转的选择，一旦成功，体重减轻 25-50%，远远超过这个数字降低风险所必需的新行为策略，可增强现有的减肥效果。需要采取干预措施。最近推出的一项创新减肥策略是“饥饿训练”。饥饿训练以实时血糖监测作为生物反馈，帮助用户自我调节开始进餐可促进持续减肥，这可能对乳腺癌风险产生间接和直接影响有证据表明，仅进行饥饿训练——无需任何额外的饮食限制或增加体力活动——体重减轻>7%，并显着提高胰岛素敏感性。在拟议的试点研究中，我们将采用双臂方法将饥饿训练与 DPP 结合起来。随机抽取 50 名非糖尿病、绝经后肥胖女性，这些女性被确定为乳腺癌高危人群并加入 MD 安德森纵向高风险乳腺队列 ≥1 年，接受 DPP 或为期 16 周的 DPP 加饥饿训练目标 1 是评估增加饥饿的可行性。 DPP 培训的可行性标准包括应计率 >50%、流失率 <20% 和协议。目标 2 是估计两个研究组的效应大小和依从率 >75% 的程度。仅 DPP 和 DPP 加饥饿培训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志物（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、白细胞介素 6 和 C 反应蛋白）；行为调节因素（例如，总能量摄入量的减少、总体饮食频率、饮食事件的百分比发生在或低于平均空腹血糖浓度）。我们期望将饥饿训练加入高度传播的减肥干预措施中，产生协同效应。发现在 DPP 中加入饥饿训练是可行的，并且联合干预具有对于有绝经后乳腺癌风险的肥胖女性，可促进体重减轻>10%。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，该试验将此外，我们还能够将 DPP 对减肥和减肥维持的长期影响与民进党加饥饿训练。