CLINICAL STUDY – SUMMARY IN TURKISH

 

STUDY FOR THE EVALUATION OF THE metabolic balance® METABOLISM PROGRAM

Summary of the Research Results

The basis of the study for the “evaluation of the metabolic balance® metabolism program”, in terms of the content, is the measurement of the treatment results in the short, medium, and the long term within the duration of the program. Besides this, the focus is on the result parameters after weight loss, improvement of the fat values, and enhancing the quality of life in terms of health.

Feedback and Analysis of Dropping Out

During the registration, a total of N=970 patients started to join the program. Out of those, N=851 patients were included in the research, so the rate of dropping out at the beginning of the research was determined as 14.0%. Only the patients whose complete records were available were included in the analyses where medical reports were evaluated. For example, the expression “all records between t0 – t1” indicates that both t0 patient form and the t1 patient form, and/or t1 consultant form are available. While the feedback rate is at a high level with 85.2% at the t1 measurement time (4 weeks after the starting date), at the t2 time (3 months after the starting date) the feedback rate decreased by approximately 10% (74.4%). The feedback rate at the t3 measurement time (6 months after the starting date) decreased to 64.4%, and at the t4 measurement time (1 year after the starting date) to 55.5%.

Since the feedback rates in the annual medical reports were not at the desired levels, later an additional measurement linked to the main research was conducted. The objective was to complete the missing data with this measurement. In this way, the feedback rate during the last measurement time was able to be increased to 61.6%. Moreover, in the additional measurement, all consultants and patients took part in the requested research to indicate possible side effects and complications they would identify with the program.

Definition of the Randomized Case Study

The analysis of the long-term treatment results is based on the data of the N=472 patients. Both t0 patient forms and t4 patient forms, and/or t4 consultant forms are available on these patients. The youngest patient who participated in the randomized case study is 19, and the oldest is 81. The average age of the patients was calculated as 50 (SD=12.0). Women comprise 84.1% of the randomized case study participants. Approximately 38.3% of the patients have midlevel education, and they form the biggest segment of the participants with this rate. Secondary school graduates make up 26.5% of the patients, while 32.8% are either vocational school graduates or hold a bachelor’s degree. While 43% of the patients are salaried employees, 18.2% own their businesses. 12.5% are housewives or househusbands. Another 12.3% are retired. Almost two thirds of the patients (65.5%) are married.

The body mass index of the average bodyweight at the beginning of the program is 30.3 (SD=5.6). The BMI value of almost half the patients (48.3%) is above 30. Furthermore, 18.5% are morbidly obese with BMI> 35. Waist circumference, which is an important criterion in the diagnosis of a metabolic syndrome, and which also poses a great risk for cardiovascular diseases, was measured as 98.8 cm on average at the beginning. 79.1% of the women and 73.2% of the men are in the zone which is interpreted as the “very high health risk”. If it is examined in terms of the cardiovascular metabolism parameters, it was observed that 31% of the patients had very high total cholesterol values (> 240 mg/dl). With regards to LDL-Cholesterol, the values are above 160 mg/dl in 23.8% of the patients. When examined in terms of triglyceride, limit values (150-199 mg/dl) were observed in 14.7% of the patients, and very high values (> 200 mg/dl) were observed in 13.8% of the patients.

The individual assessment of the life quality on the basis of health was done via the IRES-24 form, which included areas such as; “somatic condition”, “pain”, “daily activity capability”, and “psychological condition”.  According to the randomized case study norms of the IRES-24, the participants have percentages which are considered “unusual” and even “serious” in all of these four areas and most importantly in the “psychological condition” area.

Long-Term Effects

Body Mass
The information below about the change in the body weight between t0 and t4 belong to the N=420 patients who stated that losing weight was an important goal for them at the beginning of the program, and whose data from both measurement times is available. 46.2% of the patients lost so much weight during the program that they could be sorted out to lower BMI groups at the t4 measurement, compared their condition at the beginning of the program. The weight loss between the two measurements is rather obvious statistically. The average weight loss is 7.2 kg (SD=7.0). While 29 patients gained little weight (6.9%), no weight change was observed in 13 patients, and a total of 90% of the program participants lost weight. Almost two thirds of the participants (64.3%) lost more than 5% of their initial weight, and 32.6% lost 10% or more than their initial weight in the long-term.

Metabolism Parameters
The important metabolism parameters and analyses concerning the diagnosis of the metabolic syndrome confirm that health changes are achieved in the positive direction. Apart from the CK (NAC) value which showed no change, all of the metabolism parameters which were researched showed improvement. The rate of the patients with high y-GT values decreased in half from (t0) 18.2% to (t4) 8.2%. Moreover, the number of patients with high LDL-Cholesterol values declined from (t0) 23.8% to (t4) 17.4%. Total cholesterol values, which were very high in almost one third of the patients at the t0 measurement (31%), improved during this time and at the t4 measurement in only 25.7% of the patients very high values were observed. While the total cholesterol/ HDL cholesterol ratio was in optimal level (<= 3.5) at the t0 measurement in 45.7% of the research participants, this ratio increased to 59.9% during the t4 measurement. At the same time, with the triglyceride parameters in the serum at the t0 – t4 period, an obvious improvement is seen: at the beginning of the program high or very high triglyceride values were observed in 13.8% of the patients. At the end of one year, only in 7.9% of the patients high or very high triglyceride values were detected. While 10% of the patients had metabolic syndrome symptoms at the t0 measurement, this ratio decreased to 2.2% one year later. Quality of Life in terms of Health

Apparent improvements were observed at all measurements, both regarding the four dimensions of the IRES-24 form, and the summarizing total score of the form (p

“Dedication to the Program” and its Effects

When the effects of the resulted dimensions mentioned above are compared with the “dedication to the program”, particularly informative results come out. What is mentioned here is whether the patients followed the general rules of the program or not, according to their self-evaluations (e.g. three meals a day, 5 hours between the meals, starting each meal with protein etc.). The relevant evaluation showed that a better program dedication had almost a linear, and highly obvious and positive relationship with more powerful effects.

About the “Effect”

In terms of science, the changes in the result parameters cannot be causatively linked to participation to the studied nutrition program; as an observational research (without a control group) basically shows only the temporal relationship between the intervention and the results. It cannot causatively prove the effect of the intervention over the results. On the other hand, the relationship between program dedication and the results being almost linear being proven, and this situation making the inference that what leads to better results is following the program reasonably, enables making a causative interpretation at the current situation. In this regard, it can be stated that interpreting the changes in the result parameters as the effects of the program is correct.

Drop-out Analyses and Representation of the Randomized Case Study

The question of whether the participants who joined the study and showed bad effects during the study and stayed out of the study in an unsystematic way were represented at the last medical report or not, carries great importance for all efficiency studies and especially for nutrition programs. Therefore, in the current research detailed analyses are done for each measurement, and the systematic differences between the demographic indications, participation motivation, starting weight, dedication to program, weight changes, drop-outs and responders are examined compared to the previous measurement.

Prior to the 3-month medical report, the changes weren’t apparent. On the other hand, there were clear differences between the responders and the drop-outs in the 6 and 12-month medical reports in terms of age and reaching the personal goal levels: the drop-out patients are clearly younger with an average 45.1 age (SD=12.5) than the patients who continued the study (p<.001), and in the first 6-month period they are obviously behind (M=4.8; SD=2.6) compared to the responders in terms of reaching personal goals (M=6.6; SD=2.6; p<.001). The levels presented for the assessment (p=.016) show that the BMI values of the drop-out patients at the beginning of the study M=30.9 (SD=6.9), are a little over the patients who continued the study (M=29.8; SD=5.7) until the t4 measurement time. It was observed that the ones who left the study in the medium and long term were younger and less satisfied patients in terms of reaching their personal goals compared to the patients who continued the study. Although the absolute differences are not large, medium and long term treatment results (6 months and 1 year from the starting date) cannot be said to be applicable to all of the patients who were included in the research. In order to see to what extent the randomized case study, conducted with the participating patients, represents all the patients who join the metabolic-balance® program, in addition to the randomized case study, the research results were compared with all of the patients who newly joined the program in Germany, in the second half of 2007. Diet programs that metabolic balance® run for each patient within the routine framework (including age, sex, BMI, health risk status according to the waist circumference, and the reason for joining to the program) were used as data in both case studies. As a result of the comparison between the two case studies, there were significant differences in only the initial BMI, and the waist circumference: among the research participants there are significantly more patients with adiposis (p<.001) and there are patients with high health (p<.001), more than the whole case study. While interpreting these results, it should be taken into consideration that thanks to the high number of participants, (N=30.634) the prominence levels are easily accessible. In terms of the representation of those who took part in the study, the randomized case study can be said to successfully represent all of the patients who newly joined the program in the second half of 2007-except for some overweight patients. From the long-term result measurements, the following conclusion can be drawn; the metabolic balance® metabolism program provided provable improvements in life qualities in terms of health and the health conditions of the patients who took part in the study. And when assessed in terms of the patients whose goal was to lose weight, there was significant weight loss in the bodyweight. The more the participants obeyed the general rules of the programs, the more obvious these improvements became.

Cornelia Meffert, M.A.
Dr. Nikolaus Gerdes
Hochrhein-Institut für Rehabilitationsforschung
Bad Säckingen, October 2009