Outcomes of Community Naturopathic Medical Care for Type 2 Diabetes

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DESCRIPTION (provided by applicant): Diabetes is one of the most consequential and expensive chronic diseases in the U.S. Medical treatments often fail to adequately control this disease, sometimes resulting in costly and catastrophic outcomes later in life. A critical, but challenging, component of effective care is motivating persons with diabetes to change their lifestyles, particularly those aspects related to diet and physical activity. Naturopathic physicians have anecdotally reported successes in motivating their patients to control diabetes and other chronic conditions by trying to empower them to take responsibility for their health through counseling about healthy lifestyles. Although results of small retrospective studies suggest naturopathic care may improve diabetes outcomes, the potential for real world whole systems (non-protocolized) naturopathic care to improve control of diabetes has yet to be prospectively evaluated. This prospective observational study will examine the effect of one year of adjunctive naturopathic care for persons with type 2 diabetes who have an insurance benefit that covers naturopathic care. All members of an integrated health care delivery system between the ages of 21 and 65, who have type 2 diabetes with hemoglobin A1c (HbA1c) values between 7.5% and 9.5% and who are not using insulin will be identified and a random sample will be interviewed and invited to participate. The first 30 interviewed members who agree to participate will receive adjunctive naturopathic medical care for their diabetes. The characteristics (e.g., clinical and sociodemographic measures, knowledge/views of naturopathic care) of the 30 who agree to participate will be compared with those who decline. Naturopathic treatment will feature lifestyle/self-management counseling (exercise, diet, stress management, self-monitoring of blood glucose) and recommendations of botanical and nutritional supplements. Up to 8 visits over a one year period to licensed naturopathic physicians in the health plan's contracted naturopathic physician network will be allowed. Data on clinical outcomes will be extracted from the health plan's advanced automated medical records systems. Changes in HbA1c (primary outcome) and in body mass index, lipids, blood pressure and triglycerides over the one year treatment period will be measured. Patient-centered outcomes (e.g., diabetes quality of life, perceived stress, diet and exercise self-efficacy), and adherence to treatment recommendations will be assessed by telephone interviews after 6 and 12 months. A sample size of 30 participants will provide over 90% power to detect a 1.0 percentage point decrease in mean HbA1c. This study design and the availability of electronic data on clinical outcomes, will allow comparison of any improvements found for the 30 participants with those occurring for the entire study-eligible population of diabetes patients from which participants were sampled. If the results of this observational study are promising, a randomized controlled trial evaluating naturopathic care for diabetes will be proposed.