Napolitano Melissa A, Whiteley Jessica A, Mavredes Meghan N, Faro Jamie, DiPietro Loretta, Hayman Laura L, Neighbors Charles J, Simmens Samuel
Department of Prevention and Community Health, The George Washington University, Milken Institute School of Public Health, 950 New Hampshire Ave NW, Suite 300, Washington, DC 20052, USA; Department of Exercise and Nutrition Sciences, The George Washington University, Milken Institute School of Public Health, 950 New Hampshire Ave NW, Suite 200, Washington, DC 20052, USA.
College of Nursing and Health Sciences, University of Massachusetts Boston, Exercise and Health Sciences Program, 100 Morrissey Blvd, Science Center, 2(nd) Floor, Boston, MA 02125-3393, USA.
Contemp Clin Trials. 2017 Sep;60:1-13. doi: 10.1016/j.cct.2017.06.007. Epub 2017 Jun 10.
The transitional period from late adolescence to early adulthood is a vulnerable period for weight gain, with a twofold increase in overweight/obesity during this life transition. In the United States, approximately one-third of young adults have obesity and are at a high risk for weight gain.
To describe the design and rationale of a National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) sponsored randomized, controlled clinical trial, the Healthy Body Healthy U (HBHU) study, which compares the differential efficacy of three interventions on weight loss among young adults aged 18-35years.
The intervention is delivered via Facebook and SMS Text Messaging (text messaging) and includes: 1) targeted content (Targeted); 2) tailored or personalized feedback (Tailored); or 3) contact control (Control). Recruitment is on-going at two campus sites, with the intervention delivery conducted by the parent site. A total of 450 students will be randomly-assigned to receive one of three programs for 18months. We hypothesize that: a) the Tailored group will lose significantly more weight at the 6, 12, 18month follow-ups compared with the Targeted group; and that b) both the Tailored and Targeted groups will have greater weight loss at the 6, 12, 18month follow-ups than the Control group. We also hypothesize that participants who achieve a 5% weight loss at 6 and 18months will have greater improvements in their cardiometabolic risk factors than those who do not achieve this target. We will examine intervention costs to inform implementation and sustainability other universities. Expected study completion date is 2019.
This project has significant public health impact, as the successful translation could reach as many as 20 million university students each year, and change the current standard of practice for promoting weight management within university campus communities. ClinicalTrial.gov: NCT02342912.
从青春期末期到成年早期的过渡阶段是体重增加的易损期，在此生命过渡期间超重/肥胖率会增加两倍。在美国，约三分之一的年轻人患有肥胖症，且体重增加风险很高。
描述由美国国立糖尿病、消化和肾脏疾病研究所（NIDDK）资助的一项随机对照临床试验——“健康身体，健康的你”（HBHU）研究的设计和基本原理，该研究比较三种干预措施对18至35岁年轻人减肥的不同效果。
干预通过脸书和短信进行，包括：1）针对性内容（针对性）；2）定制或个性化反馈（定制）；或3）接触控制（对照）。在两个校园地点持续招募，由主站点进行干预。总共450名学生将被随机分配接受三个项目之一，为期18个月。我们假设：a）与针对性组相比，定制组在6个月、12个月和18个月随访时体重减轻显著更多；b）定制组和针对性组在6个月、12个月和18个月随访时的体重减轻均比对照组更多。我们还假设在6个月和18个月时体重减轻5%的参与者在心脏代谢危险因素方面的改善将比未达到该目标的参与者更大。我们将研究干预成本，为其他大学的实施和可持续性提供参考。预计研究完成日期为2019年。
该项目具有重大的公共卫生影响，因为成功转化后每年可能惠及多达2000万大学生，并改变大学校园社区促进体重管理的现行实践标准。临床试验.gov：NCT02342912。
