EAL

HD: Effectiveness of Nutrition Intervention Methods (2010)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To evaluate a culturally tailored intervention for rural African Americans by comparing group diabetes self-management to individual diabetes self-management.

Inclusion Criteria:

Self-identified African American
Age 18 or older
Reported diagnosis with type II diabetes mellitus
Rural residency
Able to give informed consent.

Exclusion Criteria:

17 years old or younger
Urban or suburban resident
Unable to give informed consent
No diagnosis of type II diabetes
Reported ethnicity or race other than African American.

Description of Study Protocol:

Recruitment

Methods of recruitment included contacting key community leaders, distributing flyers, making church announcements, newspaper articles and radio announcements in sites reaching African Americans.

Design

A quasi-experimental pilot study.

Intervention

Participants were randomly assigned to either an individual diabetes self-management (DSME) or a group DSME. Participants assigned to the individual DSME met with a CDE on three occasions over an eight-week period in a separate room from the group sessions. Individual sessions lasted 10 to 15 minutes and focused on reviewing goals, obstacles and progress, facilitating problem-solving. The group DMSE consisted of eight two-hour educational sessions over an eight-week period. The group session involved problem-solving and activities based on the priorities of the group.

Statistical Analysis

Demographic and outcomes measures are described as means and standard deviations for continuous variables and percentages for categorical variables. Differences between the group and individual scores were assessed using a X² test for categorical variables. Outcome measures were normally distributed within each treatment group, except for medication administration and smoking, which had skewed distributions. Because of the small sample size in the study, results for the intervention effect may be vulnerable to possible outliers; therefore, a median test was used. Intervention effect was studied by analysis of covariance (ANCOVA) to eliminate confounding from the length of diabetic status. The sample was too small for conclusive findings; however, use of the ANCOVA provides information about which variables may account for differences between variables.

Data Collection Summary:

Timing of Measurements

The study was conducted over a six-month period during 2005 and 2006. Outcomes were measured at baseline and 10 weeks and consisted of self-care activities inventory, empowerment scale, rating of personal goal achievement and Hemoglobin A1c blood test. An anonymous satisfaction questionnaire was administered after the DSME was completed. Demographic data were collected at baseline.

Dependent Variables

Goal achievement: Measured by the "Seven Self-Care Behaviors Tracking"
Daily actions for diabetes self-care: Measured by the Summary of Diabetes Self-Care Activities
Self-efficacy: Measured by the Diabetes Empowerment Scale-Short Form
Glycemic control: Measured by HgbA1c
Satisfaction with diabetes education.

Independent Variables

Group DSME
Individual DSME.

Description of Actual Data Sample:

Initial N: 22 (18 females, 4 males)
Attrition (final N): 21
Age: 27 to 85 years; average age 60 years
Ethnicity: African American
Other relevant demographics: Education level ranged from less than six years to achievement of doctoral degree (58% had less than a high school degree)
Location: Rural central Virginia.

Summary of Results:

Key Findings

Scores of Outcomes at Baseline and Post-intervention

Variables	Group DSME	Individual DSME	Statistical Significance of Group Difference
Self-efficacy	Baseline: 33.0 (4.57) Post: 36.69 (3.68) Score change: 3.58	Baseline: 34.25 (4.27) Post: 33.13 (6.71) Score change: -1.13	P=0.111 (-1.18, 10.6)
HgbA1c	Baseline: 8.1 (1.44) Post: 7.78 (1.48) Score change: -0.32	Baseline: 8.14 (1.58) Post: 7.69 (1.43) Score change: -0.24	P=0.855 (-0.89, 0.75)

Author Conclusion:

This study demonstrates that participants were willing to be randomly assigned to an intervention, and both group and individual approaches were well-received as evidenced by high scores on the "satisfaction with diabetes education" questionnaire. The focus on one individual self-care goal may account for the fact that the majority of participant in both groups were able to slightly reduce A1c levels during the 10-week period. The amount of contact time participants spent with educators in the group DSME was 16 hours, versus one to two hours for those receiving individual DSME. Even this small amount of time spent with educators in the individual DSME resulted in slight reductions in A1c.

Results of the study are limited by the small sample size and the brief follow-up of only 10 weeks. A longer time period is needed to assess an intervention's ability to to promote sustained self-care improvements and glycemic control. The participants were mostly women from one rural community and therefore the results may not apply to other demographics. This was a pilot study with a small budget and limited time. There was a lack of information about whether participants continued to take their medications or had changes in medical regimen that could have impacted clinical findings. Although results were not statistically significant, trends in the data show improvements in goal attainment and in several self-care activities among participants in both group DSME and individual DSME.

Funding Source:

Government:	NIH/NINR P-20 NR009009
University/Hospital:	Rural Health Care Research Center of the University of Virginia School of Nursing

Reviewer Comments:

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?	Yes
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)	No
	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?		Yes
	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?	Yes
	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
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
	5.2.	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
	5.4.	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?	???
	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?	???
	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?	Yes
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