New York Harbor Veterans Health Affairs, New York, NY, United States of America; Department of Medicine, New York University Grossman School of Medicine, New York, NY, United States of America.
Department of Psychology, New York University, New York, NY, United States of America.
Contemp Clin Trials. 2024 Jun;141:107523. doi: 10.1016/j.cct.2024.107523. Epub 2024 Apr 10.
Intensive weight management programs are effective but often have low enrollment and high attrition. Lack of motivation is a key psychological barrier to enrollment, engagement, and weight loss. Mental Contrasting with Implementation Intentions (MCII) is a unique imagery technique that increases motivation for behavior change. We describe our study protocol to assess the efficacy and implementation of MCII to enhance the effectiveness of VA's MOVE! or TeleMOVE! weight management programs using a procedure called "WOOP" (Wish, Outcome, Obstacle, Plan) for Veterans. We hypothesize that WOOP+MOVE! or TeleMOVE! (intervention) will lead to greater MOVE!/TeleMOVE! program engagment and consequently weight loss than MOVE!/TeleMOVE! alone (control).
Veterans are randomized to either the intervention or control. Both arms receive the either MOVE! or TeleMOVE! weight management programs. The intervention group receives an hour long WOOP training while the control group receives patient education. Both groups receive telephone follow up calls at 3 days, 4 weeks, and 2 months post-baseline. Eligible participants are Veterans (ages 18-70 years) with either obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 25 kg/m2) and an obesity-associated co-morbidity. At baseline, 6 and 12 months, we assess weight, diet, physical activity in both groups. The primary outcome is mean percent weight change at 6 months. Secondary outcomes include changes in waist circumference, diet, physical activity, and dieting self-efficacy and engagement in regular physical activity. We assess implementation using the RE-AIM framework.
If WOOP VA is found to be efficacious, it will be an important tool to facilitate weight management and improve weight outcomes.
NCT05014984.
强化体重管理计划是有效的，但通常参与率低，流失率高。缺乏动力是参与、投入和减肥的关键心理障碍。心理对比实施意图（MCII）是一种独特的意象技术，可以提高行为改变的动机。我们描述了我们的研究方案，以评估 MCII 增强 VA 的 MOVE！或 TeleMOVE！体重管理计划效果和实施的效果，使用一种称为“WOOP”（愿望、结果、障碍、计划）的程序来帮助退伍军人。我们假设 WOOP+MOVE！或 TeleMOVE！（干预组）将导致更多的 MOVE！/TeleMOVE！计划参与度，从而比 MOVE！/TeleMOVE！单独（对照组）导致更大的体重减轻。
退伍军人被随机分配到干预组或对照组。两组均接受 MOVE！或 TeleMOVE！体重管理计划。干预组接受一个小时的 WOOP 培训，而对照组接受患者教育。两组均在基线后 3 天、4 周和 2 个月接受电话随访。符合条件的参与者是年龄在 18-70 岁之间的退伍军人，患有肥胖症（BMI≥30kg/m2）或超重（BMI≥25kg/m2）以及肥胖相关合并症。在基线、6 个月和 12 个月时，我们评估两组的体重、饮食和身体活动。主要结局是 6 个月时的平均体重变化百分比。次要结局包括腰围、饮食、身体活动以及节食自我效能和定期进行身体活动的变化。我们使用 RE-AIM 框架评估实施情况。
如果 WOOP VA 被证明是有效的，它将是促进体重管理和改善体重结果的重要工具。
NCT05014984。
