NC: Diabetes Management (2007)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:

To determine the advantages of behavior-modifying education in the metabolic profile of patients with Type 2 diabetes.

Inclusion Criteria:
  • Ambulatory patients with Type 2 diabetes
  • Without insulin therapy
  • Interested in an education intervention project for a nine-month period.
Exclusion Criteria:
  • Type 2 diabetes with insulin therapy
  • Patients not on insulin that were not interested in a nine-month education intervention program.
Description of Study Protocol:

Recruitment

Patients with Type 2 diabetes, not on insulin, from a Family Medical Unit from the Mexican Social Security Institute.

Design

  • Two-hour education sessions weekly for nine months
  • Patients were assigned randomly into two group classes:
    • Thematic content included concepts and definitions of basic and applied nutrition
    • Behavior modification including:
      • An interest in the processes and effects
      • Considering the learner as a critical and creative subject
      • Search for developing the subject's natural skills and abilities to transform individual and social reality
      • Communication through dialogue
      • Using educational and community participation techniques
      • Incorporating the relationship of formative and informative objectives.

Blinding Used

None.

Intervention

Behavior modification education classes.

Statistical Analysis

  • Student's T-test 
  • Wilcoxon tests. 
Data Collection Summary:

Timing of Measurements

  • Glucose baseline and monthly for nine months
  • Total cholesterol and triglycerides baseline and monthly
  •  The value average for the last three months was used to determine the final evaluation.

Dependent Variables

  • Variable 1: Glucose measured with the glucose oxidase method
  • Variable 2: Cholesterol measured in automated fashion with an enzymatic technique
  • Variable 3: Triglycerides measured in automated fashion with an enzymatic technique. 

Independent Variables

Behavior modification diabetes education classes. 

Control Variables

Traditional diabetes education classes. 

Description of Actual Data Sample:
  • Initial N: Total of 49 patients recruited (Experimental group: N=25; Control group: N=24)
  • Attrition (final N): Not stated. Participants had to complete at least 90% of the 32 sessions
  • Age: Experimental group: 58.1±12.4 years; Control group: 57.8±8.7 years
  • Ethnicity: Hispanic
  • Other relevant demographics:
    • Duration of diabetes: Experimental group: 8.8±9 years; Control group: 11.3±11.8 years
    • Sex: Experimental group: 13 males, 12 females; Control group: 11 males, 13 females
    • Education completed: Experimental group: 44% grade school; Control group: 41% junior high school
  • Anthropometrics: Groups were considered homogeneous
  • Location: Family Medical Unit from the Mexican Social Security Institute of the Metropolitan area of Guadalajara, Mexico.

 

Summary of Results:

 

Variables

Treatment Group

Measures and Confidence Intervals

Control group

Measures and Confidence Intervals

Statistical Significance of Group Difference

Glucose

Baseline: 221±83

Subsequent Ave: 182±48

Baseline: 210±43

Subsequent Ave: 147±32

Statistical significance in experimental group

 P=0.001

Total Cholesterol

 Baseline: 235±39

Subsequent Ave: 222±27

 Baseline: 230±41

Subsequent Ave: 199±21

Statistical significance in experimental group

P=0.001

Total Triglyceride

 Baseline: 195±30

Subsequent Ave: 185±24

 Baseline: 199±25

Subsequent Ave: 148±21

Statistical significance in experimental group

P=0.001

  

Author Conclusion:
  • The authors stated that both groups were homogeneous, but not large enough a sample size to make it possible to establish statistical inferences. They did note significant differences in variables between the control and experimental groups.
  • In conclusion, the authors stated that the application of a behavior-modifying education program gives better results than a traditional intervention for metabolic control of Type 2 diabetes.
Funding Source:
University/Hospital: Mexican Social Security Institute, University of Guadalajara
Reviewer Comments:
  • The patients in both groups were screened by their own interest in education. This self-efficacy would have a positive impact in both education programs.
  • The following were not mentioned in the study:
    • Other lifestyle factors such as exercise, self-blood glucose monitoring, doctor's visits, hospitalizations and other health factors, which may have a major impact on the variables
    • Whether family members or other support people were allowed to attend the sessions
    • History of depression, which may have a negative impact on behavior change
  • The average years of diabetes for the control group was 2.5 years longer than for the experimental group. Diabetes worsens with duration, especially without the administration of insulin, which was an exclusion criteria for the study population. Therefore, positive clinical results would be more likely with the experimental group than the control, since the average duration of the disease was shorter in this group.
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
  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
 
Validity Questions
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? ???
2. Was the selection of study subjects/patients free from bias? ???
  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? ???
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? ???
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
3. Were study groups comparable? ???
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? ???
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) ???
  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? ???
  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")? ???
4. Was method of handling withdrawals described? ???
  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%.) ???
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? ???
  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? N/A
  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
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? ???
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? ???
  5.5. In diagnostic study, were test results blinded to patient history and other test results? ???
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? 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? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  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? N/A
  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? Yes
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? 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)? Yes
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? ???
  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? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes