Intervening on spontaneous physical activity to prevent weight regain in women

描述（由申请人提供）：建议更有效的长期减肥策略可能需要考虑性别差异的作用。如果，正如在雌性与雄性动物模型中所显示的那样，与男性相比，负能量平衡导致的体重减轻导致女性能量消耗的代偿性减少更大，那么肥胖治疗可能需要针对女性量身定制，以抵消这些总能量消耗的减少。我们的方法侧重于一种行为策略（自我监控），以消除通过低热量饮食和有组织的运动训练减肥的女性在非运动“自发”身体活动（SPA）中出现的代偿性减少。我们的长期研究目标是为创新治疗方案建立经验证据，以更有效地减轻女性体重并防止体重反弹。该试验的主要目标是提供初步数据和效果估计，以开始验证我们的总体假设，即预防体重减轻引起的SPA减少对女性的长期维持体重减轻比男性更有益。我们建议在72名肥胖、年龄较大（55-70岁）的男性和女性（每组36人）中采用双臂、10个月设计进行一项初步研究。参与者将被随机分配到包括低热量饮食和有氧运动的5个月标准化减肥干预（diet +EX）或相同的减肥干预，但增加了针对SPA自我监控（SM+ diet +EX）的行为成分，然后在减肥后再进行5个月的随访。这项R21探索性/发展性应用的具体目的是：主要目的是检查SPA自我监测是否能在随访阶段减少男性和女性的体重反弹；次要研究：1)在随访阶段，女性是否比男性重获更多的体重；2) SPA自我监测和性别对强化减肥期体重变化有影响；3)强化减肥期SPA自我监测和性别对SPA变化有影响；4)减重期SPA变化与随访期体重回升之间存在相关性。我们预计，这些结果将导致更大规模、更长期的试验，以明确地验证我们的假设，这可能会为目前针对女性肥胖治疗的护理标准（即，有组织的中等强度运动的独家处方）提供证据，并可能导致性别特异性治疗指南。公共健康相关性：使用热量限制和定期、有组织的锻炼的减肥计划可以减少在计划的锻炼时段之外进行的身体活动。这项研究将测试女性是否比男性在减肥过程中更多地减少了自发的日常体育活动，以及是否可以通过自我监控来防止这种减少，从而减缓或防止体重反弹。由于自发体力活动的减少可能会潜在地否定减肥治疗中有组织的锻炼计划的意图，因此了解在女性减肥期间和之后的减肥建议是否应该包括促进自发的体力活动，而不是有组织的锻炼，这一点很重要。

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.