Department of Health and Caring Sciences, Western Norway University of Applied Sciences, Bergen, Norway.
Department of Global Public Health and Primary Care, University of Bergen, Norway.
Scand J Prim Health Care. 2024 Sep;42(3):450-462. doi: 10.1080/02813432.2024.2337071. Epub 2024 Apr 8.
To examine the effects of an empowerment-based interprofessional lifestyle intervention program among people at risk of type 2 diabetes on knowledge, skills, and confidence in self-management, health, psychological well-being, and lifestyle characteristics, and to explore the participants' perceptions of participating in the intervention.
In line with the Medical Research Council complex interventions research methods framework, we conducted a randomized controlled trial with embedded qualitative interviews in primary healthcare clinics in Norway between 2019-2021. Of the patients at risk (The Finnish Diabetes Risk Score Calculator (FINDRISC) ≥15 or Body Mass Index (BMI) ≥30) 142 accepted the invitation, and 14 participants from the intervention group participated in individual interviews after the 12-month follow-up. Our primary outcome was the Patient Activation Measure (PAM-13). Secondary outcomes were EQ-5D-5L, EQ-VAS, WHO-Overall health, WHO-Overall QOL, weight, height, waist circumference, and regularity of physical activity. We used thematic analysis to analyse the qualitative data.
There was no clinically relevant differences of neither the primary nor the secondary endpoints between intervention and control group. As to the qualitative data, we identified two distinct features: 'Meaningful perspectives on lifestyle changes' and 'Lifestyle change is not a linear process due to challenges faced along the way' putting ownership of their choices in life into picture.
The negative results of the RCT stand in contrast to the findings given by the participants voices, perceiving the intervention as a key eye opener placing their health challenges in perspective. How to interpret these seemingly conflicting findings of participants being seen, heard, and understood, helping them to take more conscious ownership of their choices in life, and at the same time demonstrating no improvements in symptoms or measures, is a dilemma that needs further exploration. We should be careful to implement interventions that do not demonstrate any effects on the quantitative outcomes.
研究基于赋权的跨专业生活方式干预方案对 2 型糖尿病高危人群在自我管理知识、技能和信心、健康、心理幸福感和生活方式特征方面的影响，并探讨参与者对参与干预的看法。
根据医学研究委员会复杂干预研究方法框架，我们在 2019 年至 2021 年期间在挪威的初级保健诊所进行了一项随机对照试验，并嵌入了定性访谈。在高危人群（芬兰糖尿病风险评分计算器（FINDRISC）≥15 或体重指数（BMI）≥30）中，有 142 人接受了邀请，在 12 个月随访后，干预组的 14 名参与者参加了个人访谈。我们的主要结局指标是患者激活量表（PAM-13）。次要结局指标为 EQ-5D-5L、EQ-VAS、WHO 总体健康、WHO 总体生活质量、体重、身高、腰围和身体活动规律。我们使用主题分析对定性数据进行分析。
干预组和对照组在主要和次要终点均无临床相关差异。就定性数据而言，我们确定了两个不同的特征：“对生活方式改变的有意义的看法”和“由于沿途面临的挑战，生活方式的改变不是一个线性过程”，这将他们对生活选择的自主权放在了画面中。
RCT 的负面结果与参与者的观点形成鲜明对比，参与者认为该干预措施是一个关键的视角，使他们能够更全面地了解自己的健康挑战。如何解释这些看似矛盾的发现，即参与者被看到、听到和理解，帮助他们更有意识地对自己的生活选择负责，同时又没有改善症状或措施，这是一个需要进一步探索的困境。我们应该谨慎实施那些在定量结果上没有显示出任何效果的干预措施。
