MNT: Effectiveness of MNT for Obesity (2009)
Feigenbaum A, Pasternak S, Zusk E, Sarid M, Vinker S. Influence of intense multidisciplinary follow-up and orlistat on weight reduction in a primary care setting. BMC Fam Pract. 2005; 6(1): 5.PubMed ID: 15679893
To examine whether an effective weight-reducing treatment can be given by a family physician, comparing a regular treatment with an intensive treatment that includes close follow-up plus orlistat drug for six months.
- Obese patients (BMI more than 30) and also patients with BMI above 27
- Two or more cardiovascular disease (CVD) risk factors
- Age 20 to 75 years.
- Pregnant and lactating women
- Any contraindication to using orlistat, such as chronic malabsorption syndrome, cholestasis or pancreatic disease.
Patients were recruited from three primary care clinics in an urban area in central Israel.
Non-randomized study; the patients were divided into three groups according to their choice. Patients in group A received an orlistat (Xenical) drug plus an individualized reduced-energy diet and met with a family practitioner and dietitian every two weeks. The diet emphasized low-fat foods. Patients in group B were treated with the same drug plus a general formulated reduced-energy diet and followed up with only the family physician every four weeks. Patients in group C were given a individualized low-calorie diet, and followed up by a clinical dietitian once a month. The prescribed caloric intake was 1,200 calories for women and 1,500 calories for men. In the beginning of the treatment, all patients were instructed about the recommended rate of weight loss and a final weight reduction goal of at least 5% of their initial weight within six months. Patients who achieved the goal before the end of the study could choose to stop the intervention or complete the study. The main measure was weight loss. Anthropometric and biochemistry parameters were analyzed during the study.
- Individualized diet plus orlistat (120mg three times a day) plus dietitian or family physician counseling
- Regular diet plus orlistat (120mg three times a day) plus family physician counseling
- Individualized diet plus dietitian counseling.
- Chi square test was used to compare weight reduction and data on patients' background
- ANOVA was used with correction for pairwise multiple comparisons via Turkey post-hoc test for the measurements at the beginning of the study and continuous background data
- ANCOVA was used with post-hoc Bonferroni correction of significance.
Timing of Measurements
- Complete medical history, measurement of vital signs, body weight and height plus calculation of BMI were done before the intervention
- Weight was measured during each meeting
- The lipid profile was measured before the intervention
- A second lipid profile measurement after the intervention was done to half of the patients, only for those with dyslipidemia in the first measurement.
- Weight (kg)
- BMI (kg/m2)
- Triglycerides (mg per dL)
- LDL-cholesterol (mg per dL)
- HDL-cholesterol (mg per dL).
- Dietitian counseling
- Family physician counseling
- Individualized diet vs. regular diet.
- Initial N: 225 subjects; 158 females, 67 males
- Attrition (final N): 204. Dropout reasons:
- Group A: 47%, cost of the medication; 33%, lack of time; 20%, dissatisfaction
- Group B: 65%, cost of the medication; 23.5%, low motivation
- Age: Mean age, 48.4 years
- Other relevant demographics: 70% of the patients were women
- Anthropometrics: The BMI was higher amongst patients in the group B compared to group C, but not A
- Location: Tel Aviv, Israel.
Patients' Demographics Data, Initial Lipids Profile by Treatment Group
|Variables||Group A||Group B||Group C||P-value|
|Triglycerides (mg per dL)||170±53||184±49**||255±205||P<0.01|
|LDL (mg per dL)||150±30||156±36||152±44||NS|
|HDL (mg per dL)||42±7.0||44±6.7||47±14.9||NS|
|Average length of treatment (weeks)||13±12.0||9±4.7||23±12#||P<0.001|
*B>C; **A<B>C; #C>A>B
- Changes in lipid profile: The treatment resulted in a significant reduction in triglyceride levels in all groups. However, LDL-cholesterol level was decreased only in groups A and B, and HDL-cholesterol level did not change in any of the patients.
- Weight reduction: The percentage of patients who attained their weight reduction goals was higher in group A than in the groups B and C (51%, 13% and 9% in groups A, B and C respectively, P<0.001). 74% of the patients in group A lost less than 5% of their initial body weight and 51% had a weight-reduction between 5% to 10%. The patients' weight lost was 5.12kg in group A, 7.8kg in group B and 3.12kg in group C.
Significant weight reduction was obtained in a family physician setting. The addition of orlistat can further improve results. By providing the family physician with the proper tools, similar success can be achieved in more clinics.
The biggest limitation of this study is the non-randomization of the patients. It is possible that the patients who chose the drugs differed from those who had only the diet, introducing a confounding factor to the outcomes. There was a predominance of women in the study and significant differences between groups at baseline. Probably this study represents the segment of population more prone to try dieting and weight loss programs. In addition, the study periods for groups A and B were shorter than for Group C.
Quality Criteria Checklist: Primary Research
|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|
|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)||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|
|1.2.||Was (were) the outcome(s) [dependent variable(s)] clearly indicated?||Yes|
|1.3.||Were the target population and setting specified?||Yes|
|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|
|2.2.||Were criteria applied equally to all study groups?||Yes|
|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|
|3.||Were study groups comparable?||No|
|3.1.||Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)||No|
|3.2.||Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?||No|
|3.3.||Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)||No|
|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|
|3.6.||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?||No|
|4.1.||Were follow-up methods described and the same for all groups?||Yes|
|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%.)||Yes|
|4.3.||Were all enrolled subjects/patients (in the original sample) accounted for?||No|
|4.4.||Were reasons for withdrawals similar across groups?||???|
|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?||Yes|
|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.)||Yes|
|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|
|5.5.||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?||???|
|6.1.||In RCT or other intervention trial, were protocols described for all regimens studied?||Yes|
|6.2.||In observational study, were interventions, study settings, and clinicians/provider described?||N/A|
|6.3.||Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?||???|
|6.4.||Was the amount of exposure and, if relevant, subject/patient compliance measured?||???|
|6.5.||Were co-interventions (e.g., ancillary treatments, other therapies) described?||No|
|6.6.||Were extra or unplanned treatments described?||No|
|6.7.||Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?||Yes|
|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|
|7.1.||Were primary and secondary endpoints described and relevant to the question?||Yes|
|7.2.||Were nutrition measures appropriate to question and outcomes of concern?||Yes|
|7.3.||Was the period of follow-up long enough for important outcome(s) to occur?||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|
|7.6.||Were other factors accounted for (measured) that could affect outcomes?||No|
|7.7.||Were the measurements conducted consistently across groups?||No|
|8.||Was the statistical analysis appropriate for the study design and type of outcome indicators?||Yes|
|8.1.||Were statistical analyses adequately described and the results reported appropriately?||Yes|
|8.2.||Were correct statistical tests used and assumptions of test not violated?||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|
|8.5.||Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?||Yes|
|8.6.||Was clinical significance as well as statistical significance reported?||Yes|
|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?||Yes|
|9.1.||Is there a discussion of findings?||Yes|
|9.2.||Are biases and study limitations identified and discussed?||Yes|
|10.||Is bias due to study's funding or sponsorship unlikely?||???|
|10.1.||Were sources of funding and investigators' affiliations described?||No|
|10.2.||Was the study free from apparent conflict of interest?||???|