EAL

VN: Obesity (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To study the effect of the macrobiotic ways of living on blood sugar level, weight, pulse rate and blood pressure, prior and after lifestyle modification
To study the effect of the macrobiotic ways of living on quality of life (QOL), body, mind and spirit prior to and after lifestyle modification.

Inclusion Criteria:

Being a diagnosed patient at the Diabetes Mellitus (DM) Clinic and receiving treatment
Consent to participate in the study program
Able to live voluntarily on the facility for at least two, but not exceeding 14 weeks
Able to refrain from all medication and using the least possible chemicals
Willing to wear and use only natural fiber clothing and cloths
Willing to consume only macrobiotic food formula as prepared by the Foundation staff
Able to read and write.

Exclusion Criteria:

Having severe disease complication and is not self-reliant
Unable to remain in the program for at least two weeks.

Description of Study Protocol:

Recruitment

Recruited from the Diabetes Mellitus Clinic of Trad Provincial Hospital (Thailand) to live together at the Wanakaset Research Facility of Kasetsart University, Trad Province, which lies in a natural rehabilitated forest area.

Design

Clinical trial at an on-site treatment location for two to 14 weeks
Non-randomized and not controlled.

Blinding Used

None reported.

Intervention

Macrobiotic treatment program that includes a Formula 2 food regimen (as defined by the International Un Punto Macrobiotico Foundation, Italy) and a holistic, medically supervised treatment program. Macrobiotic treatment included the following program intervention components:

Diet components:
- Brown rice: (Doi, Ocha, Jasmine), millet, barley (unpolished and polished)
- Vegetables: Cabbage, chinese kale, chinese spinach, green oat, coriander, carrot, onion, radish
- Beans: small red beans (Asuki), chick pea, lentils, muszuri
- Seasonings: Unrefined sea salt, vegetarian kapi paste, vegetarian bean curd paste, soy sauce, crushed white sesame with salt, plum in brine
- Beverages: Buncha tea, rice milk
Kitchen utensils: Pressurized stainless steel pots, stainless steel spoons and forks, ceramic plates and bowls and avoiding chemical washing agents
Food consumption was highly regimented and followed a strict meal sequence:
- Soup (specific vegan recipe)
- Wheat (50% brown rice)
- Cooked vegetables
- Bean
- Raw vegetables
- Dessert
Food proportions:
- Cooked and raw vegetables: 50 to 55%
- Protein: 6 to 8%
- Wheat: 25 to 40%
- Dessert and fruit: 2 to 4%
Cooking water used in this study is self-produced mineral water with pH=7.2 to 7.3 (litmus paper tested)
Other program components:
- Strict physical, mental and spiritual components, emphasizing a tranquil state of mind
- All subjects stayed at a self-contained camp from two to 14 weeks. Medical and other program professionals were at the camp and managed the treatment.
- Physical activity, such as walking, massage and breathing exercises.

Statistical Analysis

Assessment questionnaire form verified for validity by Cronback’s Alfa method
Data presented by counting number, mean plus SD and percentage
Analysis using linear regression with ANOVA and sample paired T-test and or Wilcoxon Singled Ranks Test
Statistical significance set at P<0.05.

Data Collection Summary:

Timing of Measurements

Quality of life questionnaire filled out at entry and exit to the program
Once a week fasting blood drawn (on Wednesday mornings).

Dependent Variables

Mental and emotional well-being
Fasting blood glucose levels
Weight
Blood pressure
Heart rate.

Independent Variables

Diet and holistic treatment program.

Description of Actual Data Sample:

Initial N: 44 (10 males, 34 females)
Attrition (final N): None
Age: 31 to 50 years (N=7); 51 to 75 years (N=37)
Ethnicity: Thai
Anthropometrics:
- 40 patients on oral medication and four on insulin injections due to hyporesponsivity and allergy to medication or with infection
- 37 persons had diabetes between one and eight years and seven between nine and 12 years
- 36 persons had diabetes symptoms; eight with hypertension, two with high cholesterol, two with obesity
Location: Thailand.

Summary of Results:

For all non-drug-dependent subjects, weight, six-hours fasting blood sugar level, pulse rate and blood pressure were all significantly (P<0.001) lower at the end of treatment than at the beginning. (Note: Absolute changes in levels were not provided in the article. All results for physiological outcomes are presented in figures.)
Subjects (N=4) who were on diabetes medications were able to manage diabetes without drugs by the end of the program
The authors examined a number of QOL measures
The following measures were all significantly improved (P<0.000) based on the QOL instrument:
- Feeling of being unhealthy
- Reduction in the ability to bend over picking up object, kneeling and bending over
- Reduction in the ability to walk for more than one kilometer
- Body aches
- Difficulty in accomplishing chores
- Feeling of degenerating health
Emotional assessments on feeling lively, anxiety, depression, feeling well and peaceful and feeling energetic were also significantly (P<0.000) improved at the completion of the program
85.7% reported better health compared to a year earlier (P<0.000)
81% reported better emotional status compared to a year earlier (P<0.000).

Author Conclusion:

The findings at the end of the program together with QOL assessment questionnaires noted a statistically significant reduction in blood sugar levels, weight, blood pressure and heart beat ratios
Subjects were in significantly better health, more vibrant, more peaceful and more energetic
The four insulin-treated volunteers managed to maintain their blood sugar level within the range of 110 to 171mg percent without insulin injections and all volunteers were free of any adverse events.

Funding Source:

University/Hospital:	Wanakaset Research Facility of Kasetsart University, Trad Province
Other:	Unclear whether the study was funded by an organization or agency outside the university.

Reviewer Comments:

Weaknesses

The most serious flaw in the study was the failure to report measurement of changes in outcome variables (outcomes were presented in figures only). Thus, it is difficult to determine whether the statistically significant findings were clinically significant.
Small N (44)
Not randomized, not controlled
Difficult to generalize, very highly structured residental treatment situation.

Strengths

The description of the diet and other program interventions was thorough.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	No
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	No

Validity Questions
	1.	Was the research question clearly stated?	Yes
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
	1.3.	Were the target population and setting specified?	Yes
	2.	Was the selection of study subjects/patients free from bias?	No
2.	Was the selection of study subjects/patients free from bias?		No
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	N/A
	2.2.	Were criteria applied equally to all study groups?	N/A
	2.3.	Were health, demographics, and other characteristics of subjects described?	No
	2.3.	Were health, demographics, and other characteristics of subjects described?	No
	2.4.	Were the subjects/patients a representative sample of the relevant population?	No
	2.4.	Were the subjects/patients a representative sample of the relevant population?	No
	3.	Were study groups comparable?	N/A
3.	Were study groups comparable?		N/A
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	N/A
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	N/A
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	N/A
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
	4.	Was method of handling withdrawals described?	N/A
4.	Was method of handling withdrawals described?		N/A
	4.1.	Were follow-up methods described and the same for all groups?	N/A
	4.1.	Were follow-up methods described and the same for all groups?	N/A
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	N/A
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	N/A
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	N/A
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	N/A
	4.4.	Were reasons for withdrawals similar across groups?	N/A
	4.4.	Were reasons for withdrawals similar across groups?	N/A
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
	5.	Was blinding used to prevent introduction of bias?	No
5.	Was blinding used to prevent introduction of bias?		No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	No
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	No
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
	6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?	Yes
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	N/A
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	N/A
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	Yes
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	No
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	No
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	6.6.	Were extra or unplanned treatments described?	N/A
	6.6.	Were extra or unplanned treatments described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	N/A
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
	7.	Were outcomes clearly defined and the measurements valid and reliable?	Yes
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	No
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	No
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	N/A
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	N/A
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	7.7.	Were the measurements conducted consistently across groups?	N/A
	7.7.	Were the measurements conducted consistently across groups?	N/A
	8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?	No
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		No
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	No
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	No
	8.2.	Were correct statistical tests used and assumptions of test not violated?	No
	8.2.	Were correct statistical tests used and assumptions of test not violated?	No
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	No
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	No
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	No
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	No
	8.6.	Was clinical significance as well as statistical significance reported?	No
	8.6.	Was clinical significance as well as statistical significance reported?	No
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
	9.	Are conclusions supported by results with biases and limitations taken into consideration?	No
9.	Are conclusions supported by results with biases and limitations taken into consideration?		No
	9.1.	Is there a discussion of findings?	Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	No
	9.2.	Are biases and study limitations identified and discussed?	No
	10.	Is bias due to study's funding or sponsorship unlikely?	No
10.	Is bias due to study's funding or sponsorship unlikely?		No
	10.1.	Were sources of funding and investigators' affiliations described?	No
	10.1.	Were sources of funding and investigators' affiliations described?	No
	10.2.	Was the study free from apparent conflict of interest?	???
	10.2.	Was the study free from apparent conflict of interest?	???