EAL

NC: Group vs. Individual Counseling (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To determine the impact of two culturally competent education methods (individual counseling only and individual counseling in conjunction with group education) on nutrition adherence and glycemic control in Portuguese-Canadian adults with type 2 diabetes
To compare and explain differences in outcomes between the two groups using the Theory of Planned Behavior.

Inclusion Criteria:

Portuguese speaking Portuguese-Canadian adults with type 2 diabetes
Willingness to participate in the Portuguese education programming and to be randomized into the intervention or control group.

Exclusion Criteria:

Being on renal dialysis
Prior attendance at a similar educational program
Diagnosis of a mental illness.

Description of Study Protocol:

Recruitment

Participants recruited between November 2001 and 2003
Portuguese-speaking research assistant called new patients prior to their first scheduled appointment to inform them of the study
Those who met inclusion criteria and agreed to participate were included in the study.

Design

Randomized controlled trial design used to examine and compare the impact of the two groups (individual counseling or individual counseling plus group education) on nutrition adherence and glycemic control over a three-month period.

Blinding Used

Research assistants gathering initial and follow-up information were blinded to patients' groups. Diabetes Education Centre (DEC) providers were also blinded to patients' research participation status and were caring for all the participants regardless of the intervention assignment.

Intervention

The control group received individual initial assessments and ongoing individual follow-up visits. Counseling was based on the individual's metabolic profile, and on existing co-morbidities. Frequency and intensity of each follow-up visit depended on the individual"s progress and achievement of their metabolic targets and educational objectives.

The intervention group received individual counseling as well as group education, over three consecutive weekdays (total 15 hours). Group education included didactic methods, mutual goal setting, situational problem solving, cognitive re-framing and role-playing methods. One of the key components was six hours of nutrition therapy. The nutrition therapy emphasized four key messages (These messages were also emphasized in the individual counseling):

A limited and consistent intake of carbohydrates at each meal
An adequate daily intake of fruits and vegetables
Lower intake of saturated fats
Reduced fat in cooking.

An important aspect of the study was that both the individual counseling and group education was culturally appropriate in that it was conducted in the subjects native language (Portuguese) and was considerate of the cultural customs, attitudes, values, norms, beliefs and literacy level of the Portuguese community.

Statistical Analysis

Demographic variables analyzed using Pearson's chi-square statistic for categorical variables and independent T-tests or Mann-Whitney test for continuous variables
A paired T-test was used within each group to asses change from pre- to post-test scores
Analysis of covariance with the corresponding pre-test as the covariant, was performed to assess between group differences in outcomes (Theory of Planned Behavior, TPB constructs, nutrition adherence and glycemic control)
Two sample T-tests were performed to describe absolute mean difference from pre- to post-test scores between groups.
To test construct (convergent) validity of the TPB scales, Pearson's correlations were used to test the relationship between TPB constructs (independent variables) and nutrition adherence and glycemic control (dependent variables). Three multiple linear regression models were examined:
1. Attitudes, subjective norms and PBC on intentions
2. Attitudes, subjective norms and PBC and intentions on nutrition adherence
3. Attitudes, subjective norms PBC, intentions and nutrition adherence on glycemic control.
Descriptive statistics were examined to verify that the statistical assumptions required for each method of analysis were satisfied
SPSS software was used for all analysis.

Data Collection Summary:

Timing of Measurements

Baseline (first appointment) and three months after first appointment.

Dependent Variables

Nutrition adherence: Nutrition component of the summary of the diabetes Self-Care Activities Questionnaire (SDCA) to assess self-reported nutrition adherence. Nutrition component was measured on a five-point scale with responses ranging from 'never' to 'always'. Scale asks the percentage of times over the past seven days that respondents followed a diet as recommended for diabetes, limited the number of calories as recommended, ate high-fiber foods, ate high-fat foods, ate sweets and dessert. A higher score represents better adherence to the dietary recommendations for people with diabetes. (The internal consistency for the nutrition component of the SDCA was alpha=0.57).
Glycemic Control: Measured by glycosylated hemoglobin A_1c (HbA_1c).

Subjective Variables

Measured by Theory of Planned Behavior (TPB) scales. All scales focused on nutritional targets for patients with diabetes: 1) Limited and consistent intake of carbohydrates at each meal; 2) An adequate daily intake of fruits and vegetables; 3) Lower intake of saturated fats; and 4) Reduced fat in cooking.

Attitudes: TBP scale responses: 'Good' to 'bad', or 'enjoyable' to unenjoyable' (Internal consistency (IC): Alpha=0.61)
Subjective norms: TBP scale ranged from 'strongly disagree' to strongly agree' or 'approve' to 'disapprove'. (IC: Alpha=0.71)
Perceived behavioral control: TPB scale ranged from 'strongly disagree' to strongly agree' (IC: Alpha=0.84)
Intentions: TPB scale ranged from 'strongly disagree' to strongly agree' or 'definitely do' to 'definitely do not' (IC: Alpha=0.57).

Control Variables

Gender
Marital status
Employment status
Education
Gross personal income
Family history of diabetes
Length of diagnosis
Total number of DM symptoms
Diabetes management (diet only, oral agents, insulin and oral agents)
Self-monitoring of blood glucose
Baseline HbA1C
Anthropometrics (weight, height, BMI)
Number of individual follow-up visits.

Description of Actual Data Sample:

Initial N: Total of 87 participants (control group N=46; intervention group N=41)
Attrition (final N): 31% attrition; final N=61 participants; 11 male and 26 female in control group; 8 males and 17 females in intervention group
Age: 59.0±12.1 control group; 60.4±7.92 intervention group
Ethnicity: Portuguese, Canadian adults who were Portuguese-speaking
Other relevant demographics: 80% of study population were unemployed or retired
Anthropometrics: Participants were similar in weight, height, and BMI across groups
Location: Toronto Western Hospital Diabetes Education Centre (DEC), in Toronto, Ontario, Canada.

Summary of Results:

Variables		Individual Within-group change	Statistical Significance Within Control Group	Individual Plus Group Education\| Within-group change	Statistical Significance Within Intervention Group	Between-Group Difference	Statistical Significance of Between-Group Difference
Nutrition Adherence		0.20±0.08	P<0.01	0.66±0.15	P<0.001	0.42±0.14	P<0.05
Glycemic Control (HbA1c)		—-0.49±0.15	P<0.001	-0.54±0.19	P<0.01	0.08±0.34	NS
Subjective Variables	Attitudes	2.16±0.13	P<0.001	2.45±0.13	P<0.001	0.21±0.11	NS
	Subjective norms	0.33±0.10	P<0.001	0.058±0.13	P<0.001	0.25±0.13	NS
	Perceived Behavioral Control (PBC)	0.36±0.13	P<0.05	0.38±0.11	P<0.01	0.16±0.11	P<0.05
	Intentions	0.28±0.08	P<0.001	0.51±0.06	P<0.001	0.20±0.11	P<0.05

Other Findings

Attitudes, subjective norms and PBC were significantly and positively correlated with intentions to adhere to nutrition recommendations and with each other. Attitudes, subjective norms and PBC explained 18.1% of variance in intentions to adhere to nutrition recommendations, with only PBC making significant contributions (P<0.05).
Intentions, subjective norms, PBC and intentions (P<0.01) were significantly correlated with self-reported adherence to nutrition recommendations, explaining 27.6% of the variance in nutrition adherence. Subjective norms and intentions made significant contributions (P<0.05 and 0.001 respectively).
Self reported adherence to nutrition recommendations and the TPB constructs were not significantly correlated with glycemic control (HbA_1c).

Author Conclusion:

Our study findings provide some preliminary evidence that culturally competent education initiatives for Portuguese adults with type 2 diabetes may be efficacious in shaping eating behaviors. Future studies are needed to determine the long-term benefits of counselling and counselling in conjunction with group education.

Funding Source:

University/Hospital:

Ryerson University

Reviewer Comments:

This study showed that culturally sensitive education in the patient's primary language, whether individual counseling alone or individual counseling plus group education results in changes in attitudes, subjective norms, perceived behavior control, and intention to adhere to diabetes diet recommendations as well as adherence to diet recommendations. Individual counseling plus group education appears to further improve adherence to diet recommendations.

This study was short and only measured outcome at the end of the three-month study period; it would have been more helpful if participants were evaluated again after one to two years.

There were many limitations to this study, which were addressed very well by the authors. Major limitations were the very large attrition rate (31%) as well as the demographics of the study group (mostly unemployed, and low education level); this decreased the generalizability of the study. In spite of these limitations, the study shows that culturally appropriate nutrition counseling and education may improve adherence to diabetes diet; a longer term study is required to see if this ultimately affects diabetes control.

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?	Yes
2.	Was the selection of study subjects/patients free from bias?		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?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	No
3.	Were study groups comparable?		Yes
	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?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	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%.)	No
	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?	Yes
	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?		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?	Yes
	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?	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?	Yes
	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?	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?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes