Intervening on spontaneous physical activity to prevent weight regain in women

描述（由申请人提供）：更有效的长期减肥策略的建议可能需要考虑性别差异的作用。如果，如在雌性与雄性动物模型中所示，导致体重减轻的负能量平衡导致女性能量消耗的补偿性减少大于男性，则可能需要针对女性进行肥胖治疗，以覆盖总能量消耗的这些减少。我们的方法侧重于一种行为策略（自我监测），以消除补偿性减少非运动的“自发”的身体活动（SPA）中看到的妇女谁减肥的低热量饮食和结构化的运动训练。我们的长期研究目标是为创新治疗方案建立经验证据，这些治疗方案在减轻体重和防止女性体重反弹方面更有效。该试点的主要目标是提供初步数据和效果估计，以开始测试我们的总体假设，即预防体重减轻引起的SPA减少将比男性更有利于长期维持女性体重减轻。我们建议在72名肥胖、老年（55-70岁）男性和女性（每组n=36）中进行一项采用2组、10个月设计的初步研究。参与者将被随机分配到5个月的标准化减肥干预，包括低热量饮食和有氧运动（DIET+EX）或相同的减肥干预，增加了针对SPA自我监测（SM）的行为成分（SM+DIET+EX），然后在减肥后再随访5个月。该R21探索性/开发性应用的具体目标是：主要-检查SPA自我监测是否导致男性和女性在随访阶段中体重恢复较少;次要-检查：1）女性在随访阶段中体重恢复是否比男性更多; 2）SPA自我监测和性别对强化减肥阶段中的体重变化有影响; 3）SPA自我监测和性别对强化减肥阶段的SPA变化有影响; 4）减肥阶段的SPA变化与随访阶段的体重恢复之间存在关联。我们预计，这些结果将导致一个更大、更长的试验来明确检验我们的假设，这可能会提供反对当前护理标准的证据（即，结构化中等强度运动的独家处方）用于女性肥胖治疗，并可能导致性别特异性治疗指南。公共卫生相关性：使用热量限制和定期，有组织的锻炼的减肥计划可以导致减少计划锻炼课程之外的身体活动。这项研究将测试女性是否比减肥的男性更多地减少自发的日常体力活动，以及这种减少是否可以通过使用自我监测来预防，从而减缓或防止体重反弹。由于减少自发的身体活动可能会否定减肥治疗的结构化运动计划的意图，因此重要的是要知道女性减肥维持的建议是否应该包括促进自发的身体活动，而不是结构化的运动，在一段时间内和之后密集的减肥。

DESCRIPTION (provided by applicant): Recommendations for more effective long-term weight loss strategies may need to consider the role of gender differences. If, as shown in female vs. male animal models, negative energy balance resulting in weight loss results in greater compensatory reductions in energy expenditure in women compared to men, obesity treatments may need to be tailored in women to override these reductions in total energy expenditure. Our approach focuses on a behavioral strategy (self-monitoring) to eliminate the compensatory reduction in non-exercise "spontaneous" physical activity (SPA) seen in women who lose weight by means of a hypocaloric diet and structured exercise training. Our long-term research goal is to establish empirical evidence for innovative treatment options that are more effective in producing weight loss and preventing weight regain in women. The main goal of this pilot is to provide preliminary data and effect estimates to begin to test our overall hypothesis that prevention of weight loss-induced reductions in SPA will be more beneficial for long-term maintenance of weight loss in women than in men. We propose to conduct a pilot study using a 2-arm, 10-month design in 72 obese, older (55-70 yrs) men and women (n=36 per group). Participants will be randomized to a 5-month standardized weight loss intervention involving a hypocaloric diet and aerobic exercise (DIET+EX) or to the same weight loss intervention with addition of a behavioral component that targets self-monitoring (SM) of SPA (SM+DIET+EX), and then followed for another 5 months after weight loss. The specific aims of this R21 exploratory/developmental application are: Primary-To examine whether SPA self- monitoring results in less body weight regain in the follow-up phase in both men and women; Secondary-To examine whether: 1) women regain more weight than men in the follow-up phase; 2) SPA self-monitoring and gender have an effect on change in weight in the intensive weight loss phase; 3) SPA self-monitoring and gender have an effect on change in SPA in the intensive weight loss phase; 4) there is an association between SPA changes in the weight loss phase and weight regain in the follow-up phase. We anticipate that the results will lead to a larger and longer trial to definitively test our hypothesis, which could potentially provide evidence against the current standard of care (i.e., exclusive prescription of structured moderate-intensity exercise) for obesity therapy in women and may lead to sex-specific treatment guidelines. PUBLIC HEALTH RELEVANCE: Weight loss programs using caloric restriction and regular, structured exercise can lead to a reduction in physical activity performed outside of the planned exercise sessions. This study will test whether or not women reduce their spontaneous daily physical activity more than men with weight loss, and whether this reduction can be prevented by using self-monitoring, thereby slowing or preventing weight regain. Since reductions in spontaneous physical activity could potentially negate the intent of a structured exercise program for weight loss therapy, it would be important to know whether recommendations for weight loss maintenance in women should include promotion of spontaneous physical activity, rather than structured exercise, during and following a period of intensive weight loss.