Research Article: Effectiveness of a self-management support program for type 2 diabetes patients in the first years of illness: Results from a randomized controlled trial

Date Published: June 27, 2019

Publisher: Public Library of Science

Author(s): Anne L. van Puffelen, Mieke Rijken, Monique J. W. M. Heijmans, Giel Nijpels, François G. Schellevis, Noël C. Barengo.


To evaluate the immediate and six-month effectiveness of a group-based self-management support program for people diagnosed with type 2 diabetes (1–3 years post diagnosis) on diabetes self-care, distress and cognitions.

People with type 2 diabetes were randomized into the intervention (four group-based interactive sessions) or the control group (a single educational lecture) with their partners. Outcomes were measured at baseline, immediately after the third course session and six months later using validated questionnaires on diabetes self-care, distress, illness perceptions, diabetes-related attitudes, empowerment and partner support. Multilevel analyses were conducted according to the intention-to-treat principle using the data from 82 intervention and 86 control group participants, to test for differences in changes over time between the two groups.

The intervention group showed a significantly higher increase in physical activity and fruit and vegetable intake immediately after the program, whereas the low baseline levels of diabetes distress remained unaffected. Furthermore, the intervention group believed their illness to be more likely to be caused by chance/bad luck, but also felt more empowered to handle their condition and its treatment immediately after the program compared with the control group. Six months later, only the differences in empowerment had persisted.

Group-based self-management support results in favorable short-term behavioral changes and more persistent alterations in (perceived) empowerment in people living in the first years of type 2 diabetes. In order to achieve more sustainable behavioral changes, more prolonged support is necessary. This could be achieved by integrating attention to patients’ illness perceptions and continuous self-management support in regular diabetes care.

Netherlands Trial Registry NL3158.

Partial Text

People with type 2 diabetes (T2DM) face the challenge of adapting to living with a chronic and progressive condition on a daily basis. From diagnosis, people with type 2 diabetes need to adopt a multifaceted behavioral treatment regimen, to diminish the risk of developing and/or deteriorating diabetes-related complications [1] and, consequently, to maintain adequate functioning and a satisfactory quality of life [2–4]. However, the day-to-day management of chronic illness is often considered challenging, and half of the people with chronic conditions in the Netherlands appears to struggle with making the recommended behavioral changes [5]. Moreover, in the absence of symptoms, people with type 2 diabetes generally underestimate the (potential) seriousness of their condition and, consequently, the importance of engaging in self-care [6]. Support focusing on successful strategies to incorporate diabetes self-management within daily life might therefore be particularly warranted during the first years after diagnosis.

A randomized controlled trial (RCT) was carried out, comparing the effects in an intervention group to a control group. Outcome measures were assessed at baseline, immediately after the intervention program (two months from baseline) and at six months follow-up (eight months from baseline). Written informed consent was obtained from participating patients prior to the start of the study. The study was approved by the Medical Ethical Committee of the VU University Medical Center Amsterdam (VUmc) and registered in the Dutch trial register [NL3158]. The protocol of the study has been published previously [33].

Data were available from 168 participants in the study, with 82 participants in the intervention group and 86 participants in the control group (Fig 1). Even though the intervention and control group seem to somewhat differ in their sociodemographic and clinical characteristics (Table 2), these differences were not significant. Participants did not significantly differ from non-participants, with the exception of education level, which was higher among participants [41]. Thirty-one patients (18%) were lost during follow-up, with higher dropout rates in the intervention group (24%; n = 20) than in the control group (13%; n = 11). Non-response analyses showed that those lost to follow-up had a shorter diabetes duration (mean 2.1 vs. 2.5 years, p < 0.01) than those who completed the study. Furthermore, lower baseline scores on general dietary behaviors (mean 4.6 vs 5.3, p = 0.04), and psychological impact of type 2 diabetes (mean 2.8 vs. 3.1, p = 0.02) were found among dropouts, compared to participants with complete follow-up. In total, nine course groups were organized with an average of 8–9 participating patients per group. A little over half of the participants in the intervention group (54%) brought a partner to the course sessions. This study examined the immediate and six-month effectiveness of a group-based self-management support program for people with type 2 diabetes one to three years after diagnosis, and their partners. The intervention group showed more positive results regarding diabetes self-care, and empowerment than the control group. At six-months follow-up, the behavioral differences between the two groups had disappeared, while the differences in empowerment had persisted. Neither immediate nor six-month effects of the program were found on patients’ levels of diabetes-related distress. Apparently, sustainable changes in patients’ empowerment do not necessarily lead to sustainable changes in their behavior.   Source: