BACKGROUND: To assess the effects of a motivational interviewing (MI)-based patient empowerment program (PEP) on type 2 diabetes mellitus (DM) patient self-management compared to traditional diabetes health education. METHODS: Two hundred and twenty-five patients, recruited from community health centers (CHCs) and the family medicine clinic in the University of Hong Kong Shenzhen Hospital in Shenzhen, were randomly assigned to the intervention or control groups. Patients in the intervention group (n = 117) received a four-session PEP in small groups over 1 month by trained nurses and doctors. The control group (n = 108) received the traditional lecture-style health education on DM. All the patients were followed up for 3 months. Outcomes included problem areas in diabetes (PAID) that measures diabetes-related emotional distress, patient enablement index (PEI), mental health, patient satisfaction respectively as well as lifestyle behaviors were assessed at baseline, post-activity and 3 months. RESULTS: At post-intervention and the 3-month follow-up, the PAID score improved significantly in the intervention group (12.7 +/- 13.6, 5.8 +/- 7.6) compared to the control group (22.7 +/- 22.8, 11.7 +/- 14.6). No difference was found between groups for changes to exercise, diet, and medication adherence. The PEI score improved significantly at the 3-month follow-up in the MI group (7.27 +/- 2.45 versus 5.81 +/- 2.97). CONCLUSION: The PEP has a significant effect on improving diabetes-related distress, but MI was not significantly different from the traditional health education programs when it comes to the readiness to change. TRIAL REGISTRATION: NCT04120844 ClinicalTrials.gov. Date of registration October 9th 2019 (retrospectively registered).

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