Oberstaufener Schrothkur in patients with diabetes mellitus type II

Randomized controlled study evaluating the effectiveness of a 3-week Schrothkur compared to a 3-week holiday stay in Oberstaufen specificly tailored to people suffering from diabetes mellitus type 2

Description

The aim of this study is to examine whether the „Oberstaufen Schrothkur” for people suffering from diabetes mellitus type 2 compared to a holiday stay in Oberstaufen specificly tailored to the target group has a sustained positive impact on HbA1c value (primary outcome) and other diabetes-related parameters. Persons aged between 20 and 70, with a BMI of 27 or above, diagnosed with diabetes mellitus type 2 for not more than seven years and without severe diabetic complications (e.g. diabetic foot, kidney failure, and diabetic retinopathy) can participate in the study.

The effects of the intervention were examined with pre-, 2-week, post- and 3- and 6-month follow-up measurements (internal examination including blood analysis and a written survey) using a two-arm randomised controlled design.

1. Oberstaufener Schrothkur

The Schrothkur is a naturopathic treatment combining a low calorie, relatively high-carbohydrate and mainly basic diet (Schroth’s Diet). It also includes a daily change between a higher or lower intake of liquids (Schroth's Drinking Regulation) and either a daily change in higher body activities and rest days respectively. Cold and damp body wrap is given daily in the early morning - Schroth's Body Pack. The Schrothkur will always be carried out in specialised spa facilities under medical supervision. (Further information: http://www.schrothkur.de).

Further elements of the 3-week program are the participation in guided hikes, in relaxation exercises and in presentations on various diabetes-specific topics. Furthermore, an exchange of experience in the group moderated by a diabetes counselor takes place once a week. On the remaining working days there is the possibility to arrange individual meetings with the diabetes counselor.

2. Holiday stay in Oberstaufen specificly tailored to the target group

Participants of group 2 spend a 3-week holiday in Oberstaufen specificly tailored to people with diabetes mellitus type 2 and in compliance with the recommendations (nutrition / movement) of the German Diabetes Society / German Nutrition Society. It is also recommended to use the options for relaxation offered by the hotel. Likewise, participants are encouraged to use the opportunities for physical activity offered by the climatic health resort of Oberstaufen and the surrounding countryside. Furthermore, an exchange of experience in the group moderated by a diabetes counselor takes place once a week. On the remaining working days there is the option to arrange individual meetings with the diabetes counselor.

The primary outcome is the long-term glucose parameter HbA1c in conjunction with taking diabetes-related medicines at 6 months. Secondary outcomes are additional diabetes-related blood tests (fructosamine, C-peptide, proinsulin, CRP, HDL cholesterol, LDL cholesterol, triglycerides i.a.) and patient-relevant endpoints such as BMI, blood pressure, general health / quality of life, well-being, days of sick leave, and health-related behavior.

The recruitment of participants and the interventions are completed, the follow-up is ongoing.

Cooperation partners

• Oberstaufen Tourismus Marketing GmbH
• Dr. med. Vera Brosig, general practitioner, spa physician, Oberstaufen
• Dr. med. Susanne Neuy, physician for naturopathic treatment, Oberstaufen
• Dr. med. Walter Glück, internal medicine, diabetology DDG and LÄK, preventive medicine, Oberstaufen

Duration

March 2014 to March 2017

Funding

The study was funded by the Bavarian State Ministry of health and care.

Responsibility

Prof. Dr. Dr. Angela Schuh
Head of the research unit Climatotherapy / Health Resorts - Health Services Research
Angela.Schuh@med.lmu.de

Contact

Dr. Marita Stier-Jarmer, MPH
Marita.Stier-Jarmer@med.lmu.de

Dipl. SpOec Dieter Frisch
Dieter.Frisch@med.lmu.de

Registration

German Clinical Trials Register (DRKS): DRKS-ID: DRKS00010714