Behavioral Programs for Diabetes Mellitus

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Table 2. Inclusion criteria for type 2 diabetes (Key Questions 5 and 6) Parameter Criteria Population • Adults (≥18 years) with T2DM who have undergone primary diabetes education Interventions • Multicomponent behavioral programs that include at least one of: - Diabetes self-management education; OR - Structured dietary intervention (related to any of weight loss, glycemic control, or reducing risk for complications) together with one or more additional components; OR - Structured exercise/physical activity intervention together with one or more additional components. - Additional components may include interventions related to: diet or physical activity, behavioral change (including but not limited to: goal setting, problem solving, motivational interviewing, coping skills training, cognitive behavioral therapy strategies), relaxation or stress reduction, blood glucose awareness, medication adherence, or self-monitoring for diabetic complications (foot, eye, and renal tests). • Repeated provision by one or more trained individuals • Duration of intervention: minimum 4 weeks Comparators • Usual or standard care (i.e., medical management provided to all study participants), an active control (i.e. intervention in addition to usual care but not meeting our operational definition of behavioral program), or another behavioral program • Delivery methods (personnel, intensity, communication methods etc.) as reported for studies Outcomes • Behavioral outcomes - Change in physical activity (e.g., volume of activity per week) or fitness (e.g., cardiorespiratory fitness, strength) - Change in dietary or nutrient intake (i.e., energy intake, saturated fat consumption) - Adherence to medication • Clinical outcomes - Glycemic control (HbA 1c) - Change in body composition (i.e., weight, BMI, waist circumference, % body fat) - Control of blood pressure and lipids - Sleep apnea or sleep quality - Development or control of depression or anxiety • Health outcomes - Quality of life (e.g., validated tools for health-related quality of life, life satisfaction, psychosocial adaptation to illness, patient satisfaction) - Development of micro- and macrovascular complications (i.e., retinopathy, nephropathy, neuropathy, cardiovascular outcomes) - Mortality (all-cause) • Diabetes-related health care utilization - Hospital admissions - Length of stay in hospital - Emergency department admissions - Visits to specialist clinics • Program acceptability as measured by participant attrition rates Timing • Any length of postintervention followup Study design • Randomized controlled trials Settings • Community health setting (i.e., ambulatory care clinics, outpatient clinics, primary care clinics, family physician clinics, Community Health Centers, Rural Health Centers) • United States or other high-income country with a very high Human Development Index 62 Language • English BMI = body mass index; HbA 1c = hemoglobin A 1c ; T2DM = type 2 diabetes Study Selection Two members of the research team independently screened all titles and abstracts (when available) using broad inclusion/exclusion criteria (Tables 1 and 2). We retrieved the full text of any publications marked for inclusion by either reviewer. Two reviewers independently assessed the full texts using a standard form that outlined the inclusion and exclusion criteria (see Figure 14
S1 in the Supplementary File). The reviewers resolved any disagreements through consensus or by consulting a third member of the review team. We used an internally developed online tool to manage the title and abstract screening and full text review. The results from the full text review were then exported to an EndNote® database. We recorded the principal reason for excluding full text publications that did not satisfy the eligibility criteria. Data Extraction We extracted data directly into the Systematic Review Data Repository (SRDR). One reviewer extracted data, and a second reviewer checked the data for accuracy and completeness. We resolved disagreements through consensus or by consulting a third member of the review team. We extracted the following data: author identification, year of publication, source of funding, study design, population (i.e., inclusion and exclusion criteria, number of participants enrolled, study withdrawals, duration of followup), baseline characteristics (e.g., age, duration of diabetes, HbA 1c , race/ethnicity, weight, body mass index), details of the interventions and comparators, and outcomes. When more than one publication reported the results of a single study, we considered the earliest published report of the main outcome data to be the primary publication. We extracted data from the primary publication first and then any additional data reported in the associated publications; this report cites all study results to the primary publication. We only extracted outcome data at or after the end-of-intervention timepoint; interim results prior to the end of any intervention contact were not included. We recorded intention-to-treat results, if possible. Other decision rules were developed for extraction of outcome data: 1) when both subjective and objective assessment was performed for change in dietary or nutrient intake, or physical activity (e.g., exercise duration/intensity via self-report and accelerometer) we only extracted the objective data; and 2) for clinical or health outcomes relying on questionnaires (e.g., depression, anxiety, quality of life) we only extracted data when composite or component scores were provided. For studies where it was unclear whether patients had T1DM or T2DM, we developed decision rules based on mean age of study population, duration of diabetes, and the description of medical management. In studies where both types of patients were included and results were not reported separately, if more that 75 percent were one type of diabetes we included the study with that disease group. Risk of Bias Assessment of Individual Studies Two reviewers independently assessed the risk of bias (ROB) of the included studies. Discrepancies were resolved through discussion and consensus. We assessed the internal validity of RCTs and non-RCTs using the Cochrane Risk of Bias tool. 69 The tool examines seven domains of potential bias (sequence generation, concealment of allocation, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective outcome reporting, and “other” sources of data), and a categorization of the overall ROB. Each domain was rated as having “low,” “unclear (medium),” or “high” ROB. We assessed blinding and incomplete outcome data separately for subjective outcomes (e.g., quality of life) and objective outcomes (e.g., HbA 1c ); we only rated the ROB for those outcomes of interest to this review and on which we report. We reported additional sources of bias, including baseline imbalances and design-specific ROB, in the “other” sources of bias domain. 15
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Evidence Report/Technology Assessme
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This report is based on research co
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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 and 32: T2DM: Description and Risk of Bias
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Page 35 and 36: The positive findings for behaviora
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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: Table 1. Inclusion criteria for typ
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
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Page 81 and 82: HbA 1c : Comparative Effectiveness
Page 83 and 84: Two trials reported on adherence to
Page 85 and 86: Table 4. Other clinical and behavio
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Page 89 and 90: Health-Related Quality of Life: Beh
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Page 93 and 94: Table 8. Type 1 diabetes: summary o
Page 95 and 96: Summary of Key Findings and Strengt
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Table 12. Network meta-analysis for
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Table 13. 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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