Trained Individual

This can be an individual who has either received formal education and training in diabetes management and/or education, or has received some form of training to provide the specific program offered. There is no requirement to have a certain degree level or certification. This may include what is described as a lay health worker, “expert patient,” “promotores” (Spanish term), or peer, as long as training is provided.

Repeated Interaction

There must be more than one interactive session―via face-to-face or indirect means―with the personnel providing the program.

Duration of ≥4 Weeks

The minimum duration of 4 weeks does not include post-intervention follow-up assessments for outcome ascertainment.

Diabetes Self-Management Education

A program will be considered DSME if the authors state that it meets the standards for DSME in the country in which the program is delivered (i.e., the program does not just cover a set of recommended topics of education). We also will include programs aiming to change patient (not provider) behaviors that are reported to: 1) include individualized assessment of needs/behaviors (performed by the provider and/or patient); 2) provide education on multiple self-care/management behaviors using interactive approaches (these may be combined with didactic and/or collaborative approaches); and 3) incorporate some form of behavior change strategy (e.g., goal setting) whereby patients are trained to make informed decisions to self-manage their disease.

Not all topics must be provided to all patients and not all patients will receive the same duration/number of sessions, that is, there may be some tailoring of topics and delivery based on the needs assessment.

Structured Dietary Intervention

Dietary interventions may related to weight loss (e.g., caloric restriction), glycemic control (e.g., carbohydrate counting, controlling glycemic index of foods), and/or reducing risk for complications or comorbidities (e.g., reduced saturated and trans fats, increased fiber). The intervention must include interactive education/training methods (i.e., must be more than the provision of information or advice) on more than one occasion. The diet composition may either be personalized to the patient or follow a predetermined composition (e.g., low calorie diet with <30 percent fat).

Structured Physical Activity Intervention

Physical activity interventions must include either 1) personalized programs based on patient assessment and/or a patient's goals to train and facilitate behavior change, or 2) a structured intervention with a pre-determined program of activity (i.e., type, frequency, intensity and duration). The intervention must include interactive education/training methods (i.e., must be more than the provision of information or advice) on more than one occasion.

Activities that do not provide considerable energy expenditure (moderate intensity or more; goal to reach >40 percent aerobic capacity) or strength training potential will not be included (e.g., yoga, tai chi, stretching) but may be considered relaxation or stress reduction interventions.

Blood Glucose Regulation

This includes self-regulation of medication, diet, physical activity and so forth, based on results of blood glucose monitoring or awareness training. The intervention must consist of more than didactic teaching of blood glucose monitoring, teaching how to use pumps or other diabetes treatment technology, or teaching how to inject insulin. It may, for example, include practicing skills and problem solving on how to use the test results or to increase self-awareness to improve control through behaviors.

Relaxation or Stress Reduction

This includes interactive training or teaching related to meditation, yoga and other forms of non-aerobic or resistance training, or specific relaxation exercises or techniques (e.g., biofeedback). It may or may not include supervised practice.

Behavior Change Strategies

These include strategies to change behaviors but are not solely focused on emotional well-being. Strategies include, but are not limited to, motivational interviewing, coping skills training, cognitive behavioral therapy or techniques, problem-solving, goal setting, behavioral contracting, support groups, use of incentives or rewards, environmental change or barrier reduction, parent simulation, family therapy (related to problems with disease management behaviors), or anchored instruction. They must be directed at more than the single behavior in the structured diet or physical activity interventions. For example, a diet intervention with goal setting and motivational interviewing that are only related to diet will not be considered two separate interventions. The strategies do not have to be based on theory but, where they are, this will be noted during data extraction. They do not include interventions limited to screening or therapeutic counseling for mental health diagnoses or emotional issues, although general psychosocial aspects and adaptation to disease will be included.

Medication Adherence

Any ongoing or intermittent intervention (i.e., not one-time provision of advice or information) that is intended to increase adherence to medication for hyperglycemia or risk factor reduction (e.g., lipid-lowering medications). This can be technology-based (e.g., text reminders via cell phone).

Self-Monitoring for Diabetic Complications

Any ongoing or intermittent intervention (i.e., not one-time provision of advice or information) that is intended to increase self-monitoring or screening for micro- or macrovascular complications (e.g., training on home foot care, reminders to attend screening appointments). This can be technology-based (e.g., text reminders via cell phone).

Note on Classification During Data Synthesis

Because there were very few studies evaluating programs with dietary and another (non-physical activity) component, or physical activity and another (non-dietary) component, we collapsed all programs that were not DSME into a “lifestyle” category which largely contained programs focusing on diet and physical activity.

Usual (or Routine/Standard) Care

These consist of usual medical management of study participants, whether this was provided by the study investigators or other health care professionals; because medical care is so diverse, these groups could receive a minimally intense intervention such as provision of pamphlets or one individual session with an educator. Interventions which are very minimal (e.g. delivery of pamphlets) will be included in this category.

Active Comparator

Controls that were beyond usual care but not meeting our operational definition of a behavioral program were considered active controls (e.g., stand-alone dietary intervention, basic education program of short duration or not including behavioral approaches).

Other Intervention

Anything that meets our definition of behavioral health program will be categorized as an intervention.