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Pillay J, Chordiya P, Dhakal S, et al. Behavioral Programs for Diabetes Mellitus. Rockville (MD): Agency for Healthcare Research and Quality (US); 2015 Sep. (Evidence Reports/Technology Assessments, No. 221.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

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Behavioral Programs for Diabetes Mellitus.

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Introduction

Background

The high burden of diabetes necessitates careful attention to factors contributing to optimal diabetes care and self-management including lifestyle behaviors and medication adherence. Over the past few decades, much of the care and education of people with diabetes in the United States has transferred from hospitals to outpatient settings, and several guidelines and diabetes management programs have been developed to improve diabetes care in the community.1 However, an evaluation of initiatives to implement guidelines and processes of care in community health centers did not find improved control of hemoglobin A1c (HbA1c) levels for patients with diabetes.2

Approaches for supporting patients with diabetes to change behaviors include interventions such as diabetes self-management education (DSME) with or without an additional support (clinical, behavioral, psychosocial, or educational) phase, lifestyle interventions, and medical nutrition therapy. Interventions vary widely in terms of content, duration, intensity, and delivery methods. The effectiveness of these interventions for patients with type 1 diabetes (T1DM) has not been evaluated in recent years and the few existing reviews have been inconclusive.3-7 In contrast, there is a diverse evidence base supporting moderate effectiveness of these approaches for type 2 diabetes (T2DM). However, it is unknown what combination(s) of program components and delivery mechanisms are most effective for the success for T2DM. Health providers struggle with how to best support, educate, and work with patients to improve their disease control. To date, it is not clear whether there is (or what constitutes) a set of best practices associated with behavioral programs that could be implemented in community health settings.

Pathophysiology

The American Diabetes Association defines diabetes mellitus as “… a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both.”8 T1DM and T2DM are the major classes of diabetes although several others exist. T1DM accounts for 5–10 percent of cases of diabetes and usually results when the body's immune system destroys the beta cells of the pancreas, the only cells that make insulin.8 The incidence of T1DM peaks in adolescents although it can occur at any age.

T2DM accounts for 90–95 percent of cases of diabetes. It usually begins with insulin resistance in which it takes more than the usual amount of insulin to achieve a given degree of glucose regulation. T2DM occurs if, over time, the pancreas is progressively less able to secrete enough insulin to normalize blood glucose.8,9 T2DM is associated with obesity, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity, and nonwhite race or ethnicity.

Epidemiology and Burden of Disease

In 2012, 29.1 million Americans had diabetes (all types diagnosed and undiagnosed). This represents 9.3 percent of the entire population and 12.3 percent of the adult population (20 years or older).9 Older adults are disproportionately affected with diabetes; 25.9 percent of people over the age of 65 years have diabetes. African Americans, Hispanic Americans, American Indians and Alaska Natives, and some Asian Americans have a higher risk of T2DM compared to non-Hispanic whites.9 Although most cases of diabetes are T2DM, T1DM is one of the most common chronic diseases in youth, and its prevalence in the United States (1 of 433 youth aged <20) has increased over the past couple decades.10 Non-Hispanic white youth are affected with T1DM more often than all other racial or ethnic groups.11

In addition to disparities in disease prevalence, several subpopulations are considered vulnerable to poor health care access and outcomes for a variety of individual and social reasons. Race or ethnicity and socioeconomic considerations including literacy, educational levels, and household income have been shown to be associated with sub-optimal care2,12 and poorer diabetes outcomes for both T1DM and T2DM. 13-15

Diabetes-related care accounts for 11 percent of all U.S. health care expenditure16 equating to $245 billion in total costs in 2012.9 Average medical expenses are more than twice as high for a person with diabetes as they are for someone without diabetes.17 When considering medical and productivity costs, some calculations provide even more extreme differentials particularly in relation to T1DM, with national costs in 2007 per case of $2,864 for undiagnosed diabetes, $9,677 for diagnosed T2DM, and $14,856 for T1DM.16

Complications from diabetes include cardiovascular disease, retinopathy, neuropathy, nephropathy, and cerebrovascular disease, as well as comorbidities such as depression and other mental health conditions.18 In adults, the most frequent first-listed diagnoses among hospital discharges in 2010 were diseases of the circulatory system (24 percent) and diabetes (12 percent). Between 5 and 11 percent of emergency department visits are for diabetes-related complications.16 For children and adolescents in 2009, 74 percent of hospital discharges and 42 percent of emergency visits had diabetes listed as the first diagnosis. About 64 percent of these discharges and 46 percent of the emergency visits were for diabetic ketoacidosis.9

Diabetes Care and Self-Management

The mainstay of treatment for T1DM is lifelong insulin therapy. In order to achieve optimal glycemic control, people with T1DM (and especially those on multiple-dose insulin or insulin pump therapy) should self-monitor their blood sugar levels frequently during the day and adjust their insulin dose, diet and/or physical activity accordingly.19 The benefit of intensive control of blood glucose in reducing the incidence and progression of micro- and macrovascular complications was clearly demonstrated in the Diabetes Control and Complications Trial (DCCT) and a related longitudinal study.20,21 Recently, these findings have extended to demonstrate reduced mortality.22 Although these findings are promising, a meta-analysis of 12 trials (2,230 participants) of intensive versus conventional glucose control in T1DM only confirmed the reduction in development (but not progression) of microvascular complications, and stressed that the benefits should be weighed against the risks of severe hypoglycemia.23

People with T2DM are often managed progressively with an initial focus on diet (e.g., medical nutrition therapy) and physical activity, and subsequent addition of one or more oral hypoglycemic medications and in many cases also (or sole use of) insulin to obtain optimal blood glucose control. The importance of tight glycemic control for reducing the risk of microvascular complications in T2DM was first shown in the United Kingdom Prospective Diabetes Study.24,25 As with T1DM though, a meta-analysis pooling results from 28 trials (34,912 participants) of intensive control in T2DM found no significant differences for all-cause mortality or cardiovascular deaths, or for macrovascular complications including non-fatal myocardial infarction.26

Factors other than blood glucose control are important to address. Reducing the risk for diabetes-related complications in T1DM and T2DM often requires lifestyle and/or pharmacological management of body weight, blood pressure, and cholesterol levels.19,27-29 For instance, intensive lowering of blood pressure has shown to reduce major cardiovascular events by 11%.30 Lifestyle interventions targeted at weight loss, diabetes nutrition, and physical activity recommendations have been shown to be associated with weight control and improved glycemic control.31-34 Additionally, findings from two large cross-national (Diabetes, Attitudes, Wishes, and Needs [DAWN]) studies have demonstrated the importance to address other outcomes of importance for patients such as diabetes-related distress and depression.35,36

A critical element of diabetes care is education and support to enable patients to adopt and adhere to several self-care or self-management and lifestyle behaviors.37,38 DSME is designed to “reduce the burden of diabetes on individuals, families, communities and healthcare systems, and, by supporting good health, prevent or delay the onset of diabetes-related long-term complications.”39 Because knowledge acquisition alone is insufficient for behavioral changes,40,41 the focus of many national and international guidelines and recommendations for DSME has shifted from traditional didactic educational services to more patient-centered methodologies incorporating interaction and problem-solving.39,42-44 In addition, the national standards for DSME developed by the American Association of Diabetes Educators and the American Diabetes Association have incorporated the provision of ongoing diabetes self-management support “…to encourage behavior change, the maintenance of healthy diabetes-related behaviors, and to address psychological concerns.”42 In addition to DSME, a diverse range of interventions and programs have been developed that focus more on supporting patients' efforts in changing lifestyle behaviors in order to better manage glycemia and prevent complications.32

Despite the availability of new medications and devices (e.g., insulin pumps, continuous glucose monitoring), several standards for care management and DSME programs, and implementation of lifestyle interventions, the National Health and Nutrition Examination Survey found that 45 percent of adults with diabetes in the United States do not achieve glycemic targets.45 Further, the Centers for Disease Control and Prevention's Behavioral Risk Surveillance System found that 36 percent of adults diagnosed with diabetes reported no physical activity in the past 30 days.17 Other reported risk factors for diabetes-related complications included smoking (20 percent), self-reported overweight or obesity (86 percent), hypertension (58 percent), and high cholesterol (58 percent).8

Rationale for Evidence Review

Health care providers working in outpatient and primary care settings in the community struggle with how to best support, educate, and work with patients with diabetes to improve their disease control. To date, it is not clear whether there is (or what constitutes) a set of best practices associated with behavioral programs that can be implemented in the community health setting. For the purpose of this review, community health settings include ambulatory care (i.e., outpatient) clinics, primary care clinics, family physician clinics, and federally qualified health centers (i.e., Community Health Centers, and Rural Health Centers).

Self-management and lifestyle interventions have been shown to improve glycemic control for T2DM to a clinically significant extent at least in the short term.46-53 The evidence for these programs in T1DM is less conclusive. Many previous systematic reviews on topics relevant to this review for T2DM have included studies evaluating a broad scope of interventions, some of which fall short of meeting current recommendations (e.g., didactic educational interventions focused on relaying information without some form of interactive or collaborative training), and others which incorporate some enhancement of medical management (e.g., treatment algorithms) which may confound the effects of the behavioral program. Many reviews have also included studies evaluating interventions targeted at a single behavior/component (e.g., diet) rather than multiple behaviors as seems necessary for optimal disease self-management. Moreover, few assessed factors contributing to the success of the interventions,46,48,51,54,55 and even fewer analyzed the data in a manner to assess multiple factors simultaneously54―the moderating effects of program content and characteristics have therefore not been fully investigated.

Our focus for T1DM was to determine the effectiveness of behavioral programs, and for T2DM was to identify factors contributing to the effectiveness of multicomponent programs. We investigated a range of outcomes and conducted network meta-analysis (enabling simultaneous assessment of multiple variables and a wide variety of comparisons) to analyze potential moderation of effectiveness, by factors such as delivery personnel, effective community linkages, and demographic characteristics. Because of our focus on moderation of effectiveness for T2DM, we did not examine harms as we did for T1DM. This review provides information regarding the effectiveness and harms of behavioral programs (T1DM), and what combination of program components and delivery methods are most effective for implementation of these programs in community health settings (T2DM).

Scope of Review and Key Questions

A member of the public nominated this topic; the nominator wanted to know whether there is a set of best practices associated with behavioral interventions for diabetes that could be replicated in community health centers in the United States. The nominator commented that while diabetes behavioral programs that promote self-management have demonstrated various benefits, the efforts of community health centers to improve their patients' diabetes control have achieved poor results.

To address these issues, we conducted a systematic review and meta-analysis of the effectiveness of behavioral programs for diabetes. For the purpose of this review we developed an operational definition of behavioral programs that encompasses DSME (without or with an additional clinical, psychosocial, or behavioral support phase, i.e., “DSME plus support”) as well as other programs incorporating interactive components that target multiple behaviors (e.g., diet and physical activity) (see Appendix A). A commonality with all programs was that they incorporated one or more behavior change techniques,56 with or without an explicit use of a theory or model of behavior change. This definition focuses on programs, defined as “…a plan of action for an event or sequence of actions over a period that may be short or prolonged…. A health program is generally long term and often multi-faceted, whereas a health project is usually short-term and narrowly focused.”57 Our operational definition of a behavioral program is as follows.

An organized, multicomponent diabetes-specific program with repeated interactions by one or more trained individuals, with a duration of ≥4 weeks, to improve disease control and/or patient health outcomes, and consisting of at least one of the following: (a) DSME; (b) a structured dietary intervention (related to any of the following: weight loss, glycemic control, or reducing risk for complications) together with one or more additional components; or (c) a structured exercise or physical activity intervention together with one or more additional components. Additional components for (b) and (c) 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 regulation; medication adherence; or self-monitoring for diabetic complications (foot, eye, and renal tests).

We include contact with those delivering the program, rather than relying solely on “interactive behavior change technology” (e.g., patient-centered websites, automated telephone calls, and touch screen kiosks). While these tools show great promise for helping health systems meet the growing demand for diabetes management and support, they have been shown to be most effective when they support human contact.58

We address the following six Key Questions (KQs):

Key Question 1. For patients with T1DM, are behavioral programs implemented in a community health setting effective compared with usual or standard care, or active comparators in—

  1. Improving behavioral, clinical, and health outcomes?
  2. Improving diabetes-related health care utilization?
  3. Achieving program acceptability as measured by participant attrition rates?

Key Question 2. For patients with T1DM, do behavioral programs implemented in the community health setting differ in effectiveness for behavioral, clinical, and health outcomes; their effect on diabetes-related health care utilization; or program acceptability for the following subgroups of patients?

  1. Age—children and adolescents (≤18 years) and their families, young adults (19–30 years), adults (31–64 years), older adults (≥65 years)
  2. Race or ethnicity
  3. Socioeconomic status (e.g., family income, education level, literacy)
  4. Time since diagnosis (≤1 year vs. >1 year)
  5. Baseline level of glycemic control (HbA1c <7% vs. ≥7%)

Key Question 3. For patients with T1DM, does the effectiveness of behavioral programs differ based on the following factors?

  1. Program components
  2. Intensity (i.e., program duration, frequency/periodicity of interactions)
  3. Delivery personnel (e.g., dietitian, exercise specialist, physician, nurse practitioner, certified diabetes educator, lay health worker)
  4. Method of communication (e.g., individual vs. group, face to face, interactive behavior change technology, social media)
  5. Degree of tailoring based on needs assessment (e.g., educational/behavioral deficits, age or other demographics, readiness to change)
  6. Level and nature of community engagement

Key Question 4. For patients with T1DM, what are the associated harms (i.e., activity-related injury) of behavioral programs implemented in a community health setting compared with usual care, standard care, or active comparators?

Key Question 5. Among behavioral programs targeted at adults with T2DM implemented in a community health setting, what factors contribute to (a) their effectiveness for behavioral, clinical, and health outcomes; (b) their effect on diabetes-related health care utilization; and (c) program acceptability as measured by participant attrition rates? Factors include the following:

  1. Program components
  2. Program intensity
  3. Delivery personnel
  4. Methods of delivery and communication
  5. Degree of tailoring
  6. Community engagement

Key Question 6. Do the factors that contribute to program effectiveness for patients with T2DM vary across the following subpopulations?

  1. Age—young adults (19–30 years), adults (31–64 years), older adults (≥65 years)
  2. Race or ethnicity
  3. Socioeconomic status (e.g., family income, education level, literacy)
  4. Time since diagnosis (≤1 year vs. >1 year)
  5. Baseline level of glycemic control (HbA1c <7% vs. ≥7%)

Analytic Frameworks

We developed two analytic frameworks to guide the systematic review process. The figures illustrate the populations of interest and the outcomes that we reviewed. Figure 1 for T1DM notes four KQs. KQ 1, KQ 2, and KQ 4 address the potential benefits and harms of behavioral programs. The overarching boxes (components, program features) address KQ 3 related to how program components and features contribute to the effectiveness of behavioral programs.

This figure depicts the Key Questions related to patients with type 1 diabetes within the context of the PICOTS described in the previous section. In general, the figure illustrates how behavioral programs implemented in a community health setting, as compared with usual or standard care, or active comparators, may result in behavioral outcomes (e.g., self-regulation of insulin based on diet, physical activity, and glucose monitoring results, change in physical activity or fitness), clinical outcomes (e.g., glycemic control, episodes of severe hypoglycemia), and health outcomes (e.g., quality of life, development of micro- or macrovascular complications); may affect program acceptability; and may change diabetes-related healthcare utilization (e.g., hospital admissions, emergency department visits). Harms related to the intervention (i.e., activity-related injury) may occur at any point during the intervention.

Figure 1

Analytic framework for behavioral programs for type 1 diabetes mellitus. HbA1c = hemoglobin A1c; KQ = Key Question

Figure 2 for T2DM notes KQ 5 and KQ 6 that address how program components and features contribute to the effectiveness of behavioral programs.

This figure depicts the Key Questions related to patients with type 2 diabetes within the context of the PICOTS described in the previous section. In general, the figure illustrates how program features contribute to the effectiveness of behavioral programs implemented in a community health setting. Program features include program components, program intensity, delivery personnel, methods of delivery and communication, degree of tailoring, and community engagement. Measures of effectiveness include behavioral outcomes (e.g., change in physical activity or fitness, adherence to medication), clinical outcomes (e.g., glycemic control, change in body composition), and health outcomes (e.g., quality of life, development of micro- or macrovascular complications). The effect of behavioral programs on diabetes-related healthcare utilization outcomes (e.g., hospital admissions, emergency department visits) and program acceptability will also be evaluated.

Figure 2

Analytic framework for behavioral programs for type 2 diabetes mellitus. HbA1c = hemoglobin A1c; KQ = Key Question

Organization of This Report

The remainder of the report describes our methods in detail and presents the results of our synthesis of the evidence with key points and detailed syntheses. For KQ 1 we also present our assessment of the strength of evidence. The results section is organized by type of diabetes—T1DM (KQs 1-4) and T2DM (KQs 5-6). The discussion section offers our conclusions, summarizes our findings, and provides other information relevant to the interpretation of this work for clinical practice and future research. References and a list of abbreviations and acronyms follow the discussion section.

The report includes a number of appendices to provide further detail on our methods, the studies assessed, and the results not presented in the text. There is also reference to a supplementary file which may be accessed for additional information on the methods for study selection and risk of bias assessment, and for the syntheses of outcomes for T2DM which were not directly applicable to our KQs. The appendixes and supplementary file are as follows:

  • Appendix A: Operational Definitions
  • Appendix B: Literature Search Strategies
  • Appendix C: Very High Human Development Index Countries
  • Appendix D: Studies Excluded After Full-Text Review
  • Appendix E: Risk of Bias
  • Appendix F: Description of Studies and Interventions
  • Appendix G: Type 1 Diabetes Mellitus: Summary of Results From Observational Studies
  • Appendix H: Strength of Evidence Tables for Type 1 Diabetes Mellitus
  • Appendix I: Effectiveness Across Outcomes for Type 2 Diabetes Mellitus
  • Appendix J: Network Meta-analysis Results for Glycemic Control and Age Subgroup Analyses
  • Supplementary File: Full Text Screening Form, Risk of Bias Tools, and Results of Meta-Analyses for T2DM Across Outcomes (available at http://srdr.ahrq.gov)

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