• Marit Graue, Jannicke Igland, Bjørg Frøysland Oftedal, Anne Haugstvedt, Hilde Kristin Refvik Riise, Vibeke Zoffmann, Anne Karen Jenum, David Richards, and Beate-Christin Hope Kolltveit.
• Department of Health and Caring Sciences, Western Norway University of Applied Sciences, Bergen, Norway.
• Scand J Prim Health Care. 2024 Apr 8: 1131-13.

ObjectiveTo 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.Design And MethodsIn 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.ResultsThere 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.ConclusionThe 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.

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