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      Effect of a community-based diabetes self-management empowerment program on mental health-related quality of life: a causal mediation analysis from a randomized controlled trial


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          There is a paucity of evidence supporting the effectiveness of diabetes self-management education (DSME) in improving mental health-related quality of life (HRQoL) for African American and Latinos. Also, among studies supporting the favorable effects of DSME on mental HRQoL, the direct effect of DSME that is independent of improved glycemic control has never been investigated. The objectives of this study were to investigate the effect of community-based DSME intervention targeting empowerment on mental HRQoL and to determine whether the effect is direct or mediated by glycemic control.


          We conducted secondary analyses of data from the Diabetes Self-Care Study, a randomized controlled trial of a community-based DSME intervention. Study participants (n = 516) were African Americans and Latinos 55 years or older with poorly controlled diabetes (HbA1c ≥ 8.0%) recruited from senior centers and churches in Los Angeles. The intervention group received six weekly small-group self-care sessions based on the empowerment model. The control group received six lectures on unrelated geriatrics topics. The primary outcome variable in this secondary analysis was the change in Mental Component Summary score (MCS-12) from the SF-12 Health Survey between baseline and six-month follow-up. We used the change in HbA1c during the study period as the main mediator of interest in our causal mediation analysis. Additionally, possible mediations via social support and perceived empowerment attributable to the program were examined.


          MCS-12 increased by 1.4 points on average in the intervention group and decreased by 0.2 points in the control group (difference-in-change: 1.6 points, 95% CI: 0.1 to 3.2). In the causal mediation analysis, the intervention had a direct effect on MCS-12 improvement (1.7 points, 95% CI: 0.2 to 3.2) with no indirect effects mediated via HbA1c change (−0.1 points, 95% CI: −0.4 to 0.1), social support (0.1 points), and perception of empowerment (0.1 points).


          This Diabetes Self-Care Study empowerment intervention had a modest positive impact on mental HRQoL not mediated by the improvement in glycemic control, as well as social support and perception of empowerment. This favorable effect on mental HRQoL may be a separate clinical advantage of this DSME intervention.

          Trial Registration

          ClinicalTrial.gov NCT00263835.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s12913-015-0779-2) contains supplementary material, which is available to authorized users.

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          Most cited references 27

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          The prevalence of comorbid depression in adults with diabetes: a meta-analysis.

          To estimate the odds and prevalence of clinically relevant depression in adults with type 1 or type 2 diabetes. Depression is associated with hyperglycemia and an increased risk for diabetic complications; relief of depression is associated with improved glycemic control. A more accurate estimate of depression prevalence than what is currently available is needed to gauge the potential impact of depression management in diabetes. MEDLINE and PsycINFO databases and published references were used to identify studies that reported the prevalence of depression in diabetes. Prevalence was calculated as an aggregate mean weighted by the combined number of subjects in the included studies. We used chi(2) statistics and odds ratios (ORs) to assess the rate and likelihood of depression as a function of type of diabetes, sex, subject source, depression assessment method, and study design. A total of 42 eligible studies were identified; 20 (48%) included a nondiabetic comparison group. In the controlled studies, the odds of depression in the diabetic group were twice that of the nondiabetic comparison group (OR = 2.0, 95% CI 1.8-2.2) and did not differ by sex, type of diabetes, subject source, or assessment method. The prevalence of comorbid depression was significantly higher in diabetic women (28%) than in diabetic men (18%), in uncontrolled (30%) than in controlled studies (21%), in clinical (32%) than in community (20%) samples, and when assessed by self-report questionnaires (31%) than by standardized diagnostic interviews (11%). The presence of diabetes doubles the odds of comorbid depression. Prevalence estimates are affected by several clinical and methodological variables that do not affect the stability of the ORs.
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            Causal inference in statistics: An overview

             Judea Pearl (2009)
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              Group based diabetes self-management education compared to routine treatment for people with type 2 diabetes mellitus. A systematic review with meta-analysis

              Background Diabetes self-management education (DSME) can be delivered in many forms. Group based DSME is widespread due to being a cheaper method and the added advantages of having patient meet and discuss with each other. assess effects of group-based DSME compared to routine treatment on clinical, lifestyle and psychosocial outcomes in type-2 diabetes patients. Methods A systematic review with meta-analysis. Computerised bibliographic database were searched up to January 2008 for randomised controlled trials evaluating group-based DSME for adult type-2 diabetics versus routine treatment where the intervention had at least one session and =/>6 months follow-up. At least two reviewers independently extracted data and assessed study quality. Results In total 21 studies (26 publications, 2833 participants) were included. Of all the participants 4 out of 10 were male, baseline age was 60 years, BMI 31.6, HbA1c 8.23%, diabetes duration 8 years and 82% used medication. For the main clinical outcomes, HbA1c was significantly reduced at 6 months (0.44% points; P = 0.0006, 13 studies, 1883 participants), 12 months (0.46% points; P = 0.001, 11 studies, 1503 participants) and 2 years (0.87% points; P < 0.00001, 3 studies, 397 participants) and fasting blood glucose levels were also significantly reduced at 12 months (1.26 mmol/l; P < 0.00001, 5 studies, 690 participants) but not at 6 months. For the main lifestyle outcomes, diabetes knowledge was improved significantly at 6 months (SMD 0.83; P = 0.00001, 6 studies, 768 participants), 12 months (SMD 0.85; P < 0.00001, 5 studies, 955 participants) and 2 years (SMD 1.59; P = 0.03, 2 studies, 355 participants) and self-management skills also improved significantly at 6 months (SMD 0.55; P = 0.01, 4 studies, 534 participants). For the main psychosocial outcomes, there were significant improvement for empowerment/self-efficacy (SMD 0.28, P = 0.01, 2 studies, 326 participants) after 6 months. For quality of life no conclusion could be drawn due to high heterogeneity. For the secondary outcomes there were significant improvements in patient satisfaction and body weight at 12 months for the intervention group. There were no differences between the groups in mortality rate, body mass index, blood pressure and lipid profile. Conclusions Group-based DSME in people with type 2 diabetes results in improvements in clinical, lifestyle and psychosocial outcomes.

                Author and article information

                BMC Health Serv Res
                BMC Health Serv Res
                BMC Health Services Research
                BioMed Central (London )
                22 March 2015
                22 March 2015
                : 15
                [ ]Department of Medicine, Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at UCLA, 3rd Floor, 911 Broxton Ave, Los Angeles, California 90024 USA
                [ ]Department of Clinical Study and Informatics, Center for Clinical Sciences, National Center for Global Health and Medicine, 1-21-1 Toyama Shinjuku-ku, Tokyo, 162-8655 Japan
                [ ]Department of Public Health/Health Policy, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Tokyo, Bunkyo-ku 113-0033 Japan
                [ ]Department of Health Policy and Management, UCLA Fielding School of Public Health, 640 Charles E Young Dr S, Los Angeles, California 90024 USA
                © Sugiyama et al.; licensee BioMed Central. 2015

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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