Warren Alpert Medical School at Brown University and The Miriam Hospital's Weight Control and Diabetes Research Center, Providence, RI, USA.
Department of Exercise Science, Arnold School of Public Health, University of South Carolina, Columbia, SC, USA.
Contemp Clin Trials. 2020 Mar;90:105953. doi: 10.1016/j.cct.2020.105953. Epub 2020 Feb 1.
While low-intensity Internet-delivered weight loss (IDWL) programs are efficacious, many patients fail to achieve clinically significant weight loss (WL). Given the positive association between 4-week and post-treatment WL, providing a more intensive intervention for those with sub-optimal 4-week WL may improve outcomes for a greater proportion of individuals. This stepped-care approach would minimize cost by reserving more aggressive treatment for those with sub-optimal early WL.
This randomized trial examines whether the provision of brief or extended phone coaching for those with sub-optimal early WL improves 4- and 12-month WL when compared to no coaching. Secondary aims include examination of cost/kg WL and intervention engagement.
450 individuals (age 18-70 years, BMI: 25-45 kg/m) will be randomized to: 1) IDWL+3 weeks of coaching ('Brief'), 2) IDWL+12 weeks of coaching ('Extended'), or 3) IDWL only ('Control'). All individuals will receive a 4-month IDWL program followed by an 8-month IDWL maintenance program. At week 4, individuals will be classified as early sub-optimal responders (<4% WL) or initial responders (≥4% WL). Individuals with sub-optimal early WL randomized to 'Brief' or 'Extended' will receive 3 and 12 weeks of phone coaching respectively, starting at week 5. Those with sub-optimal early WL randomized to 'Control', and initial responders will not receive any coaching. Assessments will occur at 4 and 12 months.
Study findings can inform the development of more effective IDWL programs. This model which provides additional support to those with sub-optimal early WL can easily be translated into healthcare and community settings.
虽然低强度互联网减重（IDWL）项目是有效的，但许多患者未能实现临床显著的体重减轻（WL）。鉴于 4 周和治疗后 WL 之间存在正相关关系，为那些 4 周 WL 不理想的患者提供更强化的干预措施可能会提高更大比例个体的治疗效果。这种分级护理方法通过为那些早期 WL 不理想的患者保留更积极的治疗，可以最大限度地降低成本。
本随机试验研究了为那些早期 WL 不理想的患者提供简短或延长的电话辅导与不提供辅导相比，是否能改善 4 个月和 12 个月的 WL。次要目标包括检查每公斤体重 WL 的成本和干预参与度。
将 450 名（年龄 18-70 岁，BMI：25-45kg/m²）患者随机分为：1）IDWL+3 周辅导（“简短”），2）IDWL+12 周辅导（“延长”）或 3）仅 IDWL（“对照”）。所有患者都将接受为期 4 个月的 IDWL 项目，然后进行为期 8 个月的 IDWL 维持项目。在第 4 周，患者将被分类为早期不理想的应答者（<4% WL）或初始应答者（≥4% WL）。随机分配到“简短”或“延长”的早期 WL 不理想的患者将在第 5 周开始分别接受 3 周和 12 周的电话辅导。随机分配到“对照”组和初始应答者的早期 WL 不理想的患者将不接受任何辅导。评估将在 4 个月和 12 个月时进行。
研究结果可以为更有效的 IDWL 项目的开发提供信息。这种为早期 WL 不理想的患者提供额外支持的模式可以很容易地转化为医疗保健和社区环境。
