Behavioral Programs for Diabetes Mellitus

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elated to changes in physical activity and medication adherence, and findings were consistently of no difference. HRQOL was reported by fewer studies than anticipated, and the results mostly showed no difference. Results for diabetes distress favored behavioral programs compared with usual care at end of intervention (MD, -1.8; not clinically important based on prespecified threshold of 0.5 SD from the pooled studies), but not at longer followup. Diabetic retinopathy was reduced by 14 percent and very high–risk chronic kidney disease was reduced by 31 percent in participants receiving an intensive lifestyle program lasting 8 years or longer compared with didactic education and support in the largest trial, conducted by the LookAHEAD research group. Allcause mortality was 14 percent lower for those receiving behavioral programs than active control groups (RR, 0.86). KQ 5. Potential Mediators of Effectiveness for T2DM When interpreting the results for potential modifiers of effectiveness (components, intensity, delivery personnel, method of communication, degree of tailoring, and level of community engagement), we relied primarily on the relative ranking of the nodes that represented grouped factors and looked for trends in the findings based on program variables that appeared to determine whether the effects would offer clinical benefit. Some nodes had very few studies, small sample sizes, and/or wide credibility intervals. Thus we did not make any firm conclusions for a single node or for differences in 561 potential comparisons, but rather from looking across nodes with similar features. In a network meta-analysis with usual care serving as the main reference, programs demonstrating relative effect sizes for HbA 1c above our threshold for clinical importance (i.e., 0.4%) represented all three major program component categories of DSME, DSME plus support, and lifestyle. The effect sizes of minimally intensive DSME programs (≤10 contact hours) were all less than our threshold for clinical importance but were all higher than the effect sizes of active controls of educational interventions not meeting our criteria for a behavioral program (e.g., didactic education programs). Programs having higher effect sizes were more often delivered in person rather than including technology; the effective programs incorporating technology were all of moderate or high intensity (>10 contact hours). Figure D summarizes the results of the network meta-analysis for HbA 1c . ES-19
Figure D. Plot of network meta-analysis results for HbA 1c DSME = diabetes self-management education; HbA 1c = hemoglobin A 1c ; HCP = health care practitioner This plot depicts the results from our network meta-analysis for the outcome of HbA 1c (negative values favorable) when comparing groups (“nodes”) of interventions, with each group differing by at least 1 level in the categories of program component, intensity, mode of communication, delivery method, and (for DSME programs only) delivery personnel. (See Table A for categorization schema.) The factors of program duration, program tailoring, and community engagement were not used for the analysis because of overlap in meaning with other factors (e.g., community engagement often attained through use of non– health care providers) and ability to categorize based on reporting (e.g., tailoring). The dots and lines represent the mean difference (MDs) and 95% credibility intervals for the represented programs relative to usual care; the figure indicates which MDs meet or exceed our predetermined threshold for clinical importance (change of ≥0.4% HbA 1c ). For the network meta-analysis of BMI, we created nodes using four variables (i.e., program component, program intensity, method of communication, and method of delivery). Lifestyle programs resulted in the highest effect sizes for BMI. Program intensity appeared to be less important than method of delivery; providing some in-person delivery appears to be beneficial. KQ 6. Subgroups for Factors Mediating Effectiveness in T2DM In terms of overall effectiveness at longest followup for HbA 1c , participants with suboptimal glycemic control (≥7% HbA 1c ) appear to benefit more than those with good control (
Page 1 and 2: Evidence Report/Technology Assessme
Page 3 and 4: This report is based on research co
Page 5 and 6: Key Informants In designing the stu
Page 7 and 8: Peer Reviewers Prior to publication
Page 9 and 10: HbA 1c reduction were more often de
Page 11 and 12: KQ 6. Subgroups for Factors Moderat
Page 13 and 14: Figure 13. Behavioral programs for
Page 15 and 16: glycemia in reducing the incidence
Page 17 and 18: together with one or more additiona
Page 19 and 20: Figure A. Analytic framework for be
Page 21 and 22: Methods Literature Search Strategy
Page 23 and 24: With input from our Technical Exper
Page 25 and 26: participants had suboptimal baselin
Page 27 and 28: duration of diabetes ranged from 2.
Page 29 and 30: Table B. Type 1 diabetes: summary o
Page 31: T2DM: Description and Risk of Bias
Page 35 and 36: The positive findings for behaviora
Page 37 and 38: elated to the Human Development Ind
Page 39 and 40: Table D. Potential research needs b
Page 41 and 42: References 1. Renders CM, Valk GD,
Page 43 and 44: 37. Chodosh J, Morton SC, Mojica W,
Page 45 and 46: Introduction Background The high bu
Page 47 and 48: Factors other than blood glucose co
Page 49 and 50: may include interventions related t
Page 51 and 52: programs. The overarching boxes (co
Page 53 and 54: Figure 2. Analytic framework for be
Page 55 and 56: American Diabetes Association, Amer
Page 57 and 58: Table 1. Inclusion criteria for typ
Page 59 and 60: S1 in the Supplementary File). The
Page 61 and 62: clinically significant); we refer t
Page 63 and 64: Synthesis for T1DM (KQs 1-4) KQ 1:
Page 65 and 66: conducted for HbA 1c and body mass
Page 67 and 68: Applicability We followed the Metho
Page 69 and 70: Type 1 Diabetes Mellitus This secti
Page 71 and 72: therapy, 90,99,108 motivational enh
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Page 75 and 76: followup (low SOE for both); there
Page 77 and 78: Figure 6. Behavioral programs for t
Page 79 and 80: similar results were found for yout
Page 81 and 82: HbA 1c : Comparative Effectiveness
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Two trials reported on adherence to
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Table 4. Other clinical and behavio
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Figure 14. Behavioral programs for
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Health-Related Quality of Life: Beh
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estimated effects were imprecise an
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Table 8. Type 1 diabetes: summary o
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Summary of Key Findings and Strengt
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studies 82,94,95,105,109,112 were n
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studied a DSME program in patients
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I 2 =74%), 135,137,139,141,142,145,
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Aerobic Fitness Test which estimate
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Key Points: Body Mass Index • Lif
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Table 12. Network meta-analysis for
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Figure 20. Plot of network meta-ana
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active comparator (20 trials, 7,709
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Discussion Key Findings and Discuss
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to be tempered by the findings of n
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compared with usual care. There was
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Our finding that single-topic, non-
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In their systematic review and meta
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For studies targeting adults, the m
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environmental contextual factors—
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assessors was also rarely reported,
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Tailoring programs to ethnic minori
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17. Centers for Disease Control and
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53. Medical Advisory Secretariat. B
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88. Ellis DA, Templin T, Naar-King
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122. Nansel TR, Iannotti RJ, Simons
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158. Cooper H, Booth K, Gill G. A t
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191. Koo BK, Han KA, Ahn HJ, et al.
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224. Sevick MA, Korytkowski M, Ston
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260. Yuan C, Lai CW, Chan LW, et al
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295. Ayling K, Brierley S, Johnson
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Appendix A. Operational Definitions
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the structured diet or physical act
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Appendix B. Literature Search Strat
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1. MeSH descriptor: [Diabetes Melli
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35. “blood glucose” N2 monitor*
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35. (behavio?r adj2 therap*).mp. 36
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52. exp animals/ not humans.sh. 53.
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57. "Follow-Up Studies"[Mesh] 58. "
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URL provided by Michelle Crain, AAD
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WHO ICTRP Trial Registry: WHO ICTRP
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Appendix D. Studies Excluded After
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Health. 2006;6:134. PMID: 16709243.
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November/December;24(9):450-6. PMID
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89. Dinneen SF, O'hara MC, Byrne M,
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119. Fitzpatrick SL, Jeffery R, Joh
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Aug;19(8):835-42. PMID: 8842601. Ex
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adherence and metabolic control. Di
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May;36(5):1297-303. PMID: 23223405.
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244. Korytkowski MT, Koerbel GL, Ko
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275. Maljanian R, Grey N, Staff I,
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306. Naccashian Z. The impact of di
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led structured program on blood glu
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Engineering. 2014;75(1-B E). PMID:
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395. Skoro-Kondza L, Tai SS, Gadelr
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426. Torbjornsen A, Jenum AK, Smast
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Americans with type 2 diabetes. J A
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patients. Diabetes Res Clin Pract.
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Table E1. Risk of bias for studies
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Weinger, 2011 L M NA M NA L NA L L
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Cramer, 2007 M M H M H L H H L M H
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Ridgeway, 1999 M M H M H L H H M L
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Appendix F. Description of Studies
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Author, Year & Country Comparison &
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Table F3. Description of studies an
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Appendix H. Strength of Evidence Ta
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Outcome # Trials (# Subjects); Tool
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Table H3. Behavioral programs compa
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16. Mayer-Davis EJ, Seid M, Crandel
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Table I1. Effectiveness of behavior
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Category Health Outcomes Outcomes A
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Table I2. Effectiveness of behavior
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Category Outcomes Timepoint Health
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Outcome Change in Body Composition
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Outcome Change in Physical Activity
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References for Appendix I 1. Adachi
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32. Rock CL, Flatt SW, Pakiz B, et
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follow-up study. Diabetes Res Clin
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98. Johnson ST, Bell GJ, Mccargar L
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Appendix J. Network Meta-Analysis R
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5 11-26h In person Group only NA -0
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9 11-26h In person Group only NA -0
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Behavioral Programs for Diabetes Mellitus

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