title: 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.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrial.gov NCT00263835.
authors.affiliation: 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. tsugiyama-tky@umin.ac.jp.|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. tsugiyama-tky@umin.ac.jp.|Department of Public Health/Health Policy, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Tokyo, Bunkyo-ku, 113-0033, Japan. tsugiyama-tky@umin.ac.jp.
authors.forename: Takehiro
authors.initials: T
authors.lastname: Sugiyama
authors.affiliation: 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. NSteers@mednet.ucla.edu.
authors.forename: William Neil
authors.initials: WN
authors.lastname: Steers
authors.affiliation: 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. NWenger@mednet.ucla.edu.
authors.forename: Neil S
authors.initials: NS
authors.lastname: Wenger
authors.affiliation: 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. kduru@mednet.ucla.edu.
authors.forename: Obidiugwu Kenrik
authors.initials: OK
authors.lastname: Duru
authors.affiliation: 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. CMangione@mednet.ucla.edu.|Department of Health Policy and Management, UCLA Fielding School of Public Health, 640 Charles E Young Dr S, Los Angeles, California, 90024, USA. CMangione@mednet.ucla.edu.
authors.forename: Carol M
authors.initials: CM
authors.lastname: Mangione
mesh_terms: D001741:Black or African American / Q000193:education; D000368:Aged; D000369:Aged, 80 and over; D003152:Community Health Nursing / Q000458:organization & administration*; D003920:Diabetes Mellitus / Q000628:therapy*; D005260:Female; D006266:Health Education / Q000379:methods*; D006630:Hispanic or Latino / Q000193:education; D006801:Humans; D015141:Los Angeles; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic / Q000379:methods*; D011209:Power, Psychological; D011788:Quality of Life; D012648:Self Care / Q000379:methods*; D012944:Social Support