Feig Emily H, Harnedy Lauren E, Thorndike Anne N, Psaros Christina, Healy Brian C, Huffman Jeff C
Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States.
Harvard Medical School, Boston, MA, United States.
JMIR Res Protoc. 2022 Oct 6;11(10):e39856. doi: 10.2196/39856.
Physical activity levels after bariatric surgery are usually low, despite the significant protective health benefits of physical activity in this population. Positive psychological well-being is associated with improved adherence to health behaviors, but bariatric surgery patients often have negative associations with physical activity that prevent sustained engagement.
The Gaining Optimism After weight Loss Surgery (GOALS) pilot randomized controlled trial is aimed at testing a novel intervention to increase physical activity after bariatric surgery, which incorporates positive psychological skill-building with motivational interviewing and goal-setting.
The GOALS trial is a 2-arm, 24-week pilot randomized controlled trial that aims to enroll 58 adults who report less than 200 minutes per week of moderate to vigorous physical activity and a desire to become more active 6-12 months after bariatric surgery. GOALS is testing the feasibility, acceptability, and preliminary efficacy of a positive psychology-motivational interviewing telephone intervention targeting to increase physical activity and associated positive affect. Intervention components include positive psychology, goal-setting, self-monitoring via provided Fitbits, and motivational interviewing to overcome barriers and increase motivation. The intervention is compared to a physical activity education control that includes mailings with psychoeducation around physical activity and provision of a Fitbit. The primary outcomes of the pilot trial are feasibility and acceptability, measured as session completion rates and participant ratings of ease and helpfulness of each session. The main secondary outcome is change in accelerometer-measured moderate to vigorous physical activity post intervention and at 24-week follow-up. Additional outcomes include changes in attitudes related to physical activity, psychological well-being, and physical health measures.
This multiphase project was funded in 2020 and institutional review board approval was obtained for the proposed trial in 2021. Recruitment for the randomized controlled trial began in July 2022. Upon completion of the pilot trial, we will examine the feasibility, acceptability, and preliminary efficacy of the intervention.
Although bariatric surgery is the most effective treatment available for severe obesity, weight regain occurs, often in the context of low psychological well-being. Many individuals would benefit from learning strategies to increase positive psychological well-being after bariatric surgery, which could help them maintain lifestyle changes. Positive psychology is a novel approach to improve adherence by increasing positive associations with health behaviors including physical activity. The GOALS pilot trial will determine whether this type of intervention is feasible and acceptable to this population and will provide a foundation for a future full-scale randomized controlled efficacy trial.
ClinicalTrials.gov NCT04868032; https://clinicaltrials.gov/ct2/show/NCT04868032.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/39856.
尽管体育活动对肥胖症手术患者有显著的健康保护益处，但该人群术后的体育活动水平通常较低。积极的心理健康与更好地坚持健康行为相关，但肥胖症手术患者往往对体育活动有负面认知，这阻碍了他们持续参与。
减肥手术后增强乐观情绪（GOALS）试点随机对照试验旨在测试一种新型干预措施，以增加肥胖症手术后的体育活动，该干预措施将积极心理技能培养与动机性访谈和目标设定相结合。
GOALS试验是一项双臂、为期24周的试点随机对照试验，旨在招募58名成年人，这些人报告每周进行中度至剧烈体育活动的时间少于200分钟，且希望在肥胖症手术后6至12个月变得更加活跃。GOALS正在测试一种针对增加体育活动及相关积极情绪的积极心理学 - 动机性访谈电话干预措施的可行性、可接受性和初步疗效。干预内容包括积极心理学、目标设定、通过提供的Fitbit进行自我监测，以及通过动机性访谈来克服障碍并增强动力。将该干预措施与一项体育活动教育对照进行比较，该对照包括围绕体育活动的心理教育邮件以及提供一个Fitbit。试点试验的主要结局是可行性和可接受性，通过课程完成率以及参与者对每节课程的难易程度和帮助程度的评分来衡量。主要的次要结局是干预后及24周随访时，通过加速度计测量的中度至剧烈体育活动的变化。其他结局包括与体育活动相关的态度、心理健康和身体健康指标的变化。
这个多阶段项目于2020年获得资助，并于2021年获得机构审查委员会对拟议试验的批准。随机对照试验的招募工作于2022年7月开始。在试点试验完成后，我们将检查该干预措施的可行性、可接受性和初步疗效。
尽管肥胖症手术是治疗重度肥胖最有效的方法，但体重往往会反弹，且通常发生在心理健康水平较低的情况下。许多人将从学习策略以增强肥胖症手术后的积极心理健康中受益，这有助于他们维持生活方式的改变。积极心理学是一种通过增加与包括体育活动在内的健康行为的积极关联来提高依从性的新方法。GOALS试点试验将确定这种类型的干预措施对该人群是否可行和可接受，并将为未来全面的随机对照疗效试验奠定基础。
ClinicalTrials.gov NCT04868032；https://clinicaltrials.gov/ct2/show/NCT04868032。
国际注册报告标识符（IRRID）：PRR1 - 10.2196/39856。
