Study of Novel Approaches to Weight Gain Prevention - Extension (SNAP-E)

 描述(申请人提供)：本申请旨在跟踪体重增加预防(SNAP)新方法研究(GRANT#U01-HL090864)的参与者，这是一项随机临床试验，已成功地在3年内减少了年轻人的体重增加。Snap是第一个在这个年龄段的人群中显示出积极效果的体重增加预防试验。SNAP扩展(SNAP-E)将具有成本效益地确定干预的效果是否可以在另外3年内保持(总共6年)。20-35岁的年轻人平均每年增加2磅，增加了他们患肥胖症和肥胖相关并发症的风险。此前防止体重增加的努力收效甚微。SNAP是一项随机对照临床试验，涉及599名参与者，年龄18-35岁，体重指数23-30，比较对照组和两种创新干预措施平均3年的体重变化。这两种干预措施都是基于自我调节模型，包括频繁的自我称重，以及在体重增加时改变饮食和活动。然而，一种干预措施侧重于在饮食和锻炼行为上进行微小的一致性改变，以防止体重增加；另一种干预措施强调定期较大规模的饮食和锻炼改变，目的是为预期的体重增加提供缓冲。到目前为止，Snap的保留率很高，并表明这两种干预措施在3年内都显著减少了体重增加。虽然两种干预措施的体重变化在3年内彼此没有不同，但它们的体重变化轨迹非常不同，这引发了对长期疗效的质疑。继续跟踪这些参与者对于确定在这些干预过程中传授的技能和由此产生的对体重增加的有益影响是否长期保持以及大的和小的改变方法的结果是否存在差异至关重要。在SNAP-E中，我们将使用远程技术为小型和大型更改团体提供最低限度的干预，并将使用智能天平和在线问卷每隔6个月跟踪所有参与者。第六年将进行最后一次临床评估，包括身体成分、心血管疾病(CVD)风险因素、饮食摄入量和体力活动的客观评估，所有这些评估都使用在整个SNAP中使用的程序。SNAP-E的主要假设是，从基线到6年的体重增加幅度将在三个手臂之间有所不同。第二个假设比较了两组在体重增加、心血管疾病危险因素和体重控制行为方面的差异。预防体重增加可能是比治疗肥胖症更有效的公共卫生方法。Snap是第一项显示干预年轻人体重增加的长期好处的研究。在SNAP-E中继续跟踪这些参与者提供了一个具有成本效益的独特机会来回答有关预防体重增加的重要问题。

 DESCRIPTION (provided by applicant): This application seeks to follow the participants in Study of Novel Approaches to Weight Gain Prevention (SNAP) (Grant #U01-HL090864), a randomized clinical trial that has successfully reduced weight gain in young adults through 3 years. SNAP is the first weight gain prevention trial to show positive effects over an extended time period in this age group. The SNAP-Extension (SNAP-E) will cost-effectively determine whether the effects of the intervention can be maintained over 3 additional years (through a total of 6 years). Young adults, ages 20-35, gain on average 2 pounds per year, increasing their risk of developing obesity and obesity related co-morbidities. Previous efforts to prevent this weight gain have had limited success. SNAP is a randomized controlled clinical trial involving 599 participants, age 18-35 with a BMI of 23- 30, comparing weight changes over an average follow-up of 3 years in a control group and two innovative interventions. Both interventions are based on a self-regulation model, involving frequent self-weighing and changes in eating and activity if weight gain occurs. However, one intervention focuses on making small consistent changes in eating and exercise behavior to prevent weight gain; the other emphasizes periodic larger changes in eating and exercise, with a goal of producing a buffer against anticipated weight gains. SNAP has had excellent retention to date and has shown that both interventions significantly reduced weight gain relative to control through 3 years. Although weight changes in the two interventions do not differ from each other at 3 years, they have had very different weight change trajectories, raising questions about long- term efficacy. Continuing to follow these participants is critical to determine whether the skills imparted during these interventions and the resulting beneficial effects on weight gain are maintained longer term and whether there are differences in outcomes for large and small change approaches. In SNAP-E we will provide minimal intervention for the Small and Large Change groups using remote technology and will follow all participants at 6 month intervals using Smart Scales and on-line questionnaires. There will be one final clinic assessment at Year 6, with measures of body composition, cardiovascular disease (CVD) risk factors, dietary intake and objective assessment of physical activity, all implemented using procedures that were used throughout SNAP. The primary hypothesis of SNAP-E is that the magnitude of weight gain from baseline to 6 years will differ among the three arms. Secondary hypotheses compare the groups on dichotomous measures of weight gain, on CVD risk factors, and on weight control behaviors. Preventing weight gain may be a more effective public health approach than treating obesity. SNAP is the first study to show long-term benefits of an intervention on weight gain in young adults. Continuing to follow these participants in SNAP-E provides a cost-effective and unique opportunity to answer important questions about weight gain prevention.