Wittleder Sandra, Smith Shea, Wang Binhuan, Beasley Jeannette M, Orstad Stephanie L, Sweat Victoria, Squires Allison, Wong Laura, Fang Yixin, Doebrich Paula, Gutnick Damara, Tenner Craig, Sherman Scott E, Jay Melanie
Department of Medicine, New York University School of Medicine, New York City, New York, USA.
Department of Population Health, New York University School of Medicine, New York City, New York, USA.
BMJ Open. 2021 Feb 26;11(2):e043013. doi: 10.1136/bmjopen-2020-043013.
Among US veterans, more than 78% have a body mass index (BMI) in the overweight (≥25 kg/m) or obese range (≥30 kg/m). Clinical guidelines recommend multicomponent lifestyle programmes to promote modest, clinically significant body mass (BM) loss. Primary care providers (PCPs) often lack time to counsel and refer patients to intensive programmes (≥6 sessions over 3 months). Using peer coaches to deliver obesity counselling in primary care may increase patient motivation, promote behavioural change and address the specific needs of veterans. We describe the rationale and design of a cluster-randomised controlled trial to test the efficacy of the Peer-Assisted Lifestyle (PAL) intervention compared with enhanced usual care (EUC) to improve BM loss, clinical and behavioural outcomes (aim 1); identify BM-loss predictors (aim 2); and increase PCP counselling (aim 3).
We are recruiting 461 veterans aged 18-69 years with obesity or overweight with an obesity-associated condition under the care of a PCP at the Brooklyn campus of the Veterans Affairs NY Harbor Healthcare System. To deliver counselling, PAL uses in-person and telephone-based peer support, a tablet-delivered goal-setting tool and PCP training. Patients in the EUC arm receive non-tailored healthy living handouts. In-person data collection occurs at baseline, month 6 and month 12 for patients in both arms. Repeated measures modelling based on mixed models will compare mean BM loss (primary outcome) between study arms.
The protocol has been approved by the Institutional Review Board and the Research and Development Committee at the VA NY Harbor Health Systems (#01607). We will disseminate the results via peer-reviewed publications, conference presentations and meetings with stakeholders.
NCT03163264; Pre-results.
在美国退伍军人中，超过78%的人体重指数（BMI）处于超重（≥25 kg/m²）或肥胖范围（≥30 kg/m²）。临床指南推荐采用多成分生活方式项目来促进适度的、具有临床意义的体重减轻。初级保健提供者（PCP）通常缺乏时间为患者提供咨询并将其转介至强化项目（3个月内≥6次咨询）。利用同伴教练在初级保健中提供肥胖咨询可能会提高患者的积极性，促进行为改变并满足退伍军人的特殊需求。我们描述了一项整群随机对照试验的基本原理和设计，以测试同伴辅助生活方式（PAL）干预与强化常规护理（EUC）相比在改善体重减轻、临床和行为结局方面的疗效（目标1）；确定体重减轻的预测因素（目标2）；并增加初级保健提供者的咨询（目标3）。
我们正在招募461名年龄在18 - 69岁之间、患有肥胖症或超重且伴有肥胖相关疾病的退伍军人，他们在纽约港退伍军人事务医疗系统布鲁克林校区的初级保健提供者处接受治疗。为提供咨询，PAL采用面对面和电话形式的同伴支持、平板电脑提供的目标设定工具以及初级保健提供者培训。EUC组的患者收到非定制的健康生活手册。两组患者均在基线、第6个月和第12个月进行面对面数据收集。基于混合模型的重复测量建模将比较研究组之间的平均体重减轻（主要结局）。
该方案已获得纽约港退伍军人事务医疗系统机构审查委员会和研发委员会的批准（#01607）。我们将通过同行评审出版物、会议报告以及与利益相关者的会议来传播研究结果。
NCT03163264；预结果。
