EAL

HD: Effectiveness of Nutrition Intervention Methods (2010)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To assess the impact that self-management education and support have on diabetes control in the area of the United States' border with Mexico.

Inclusion Criteria:

Not specifically explained in this paper.

Exclusion Criteria:

Not identified in this paper.

Description of Study Protocol:

Recruitment

Completed by the promotoras (community health workers)
Potential participants were identified through the health center database and personally invited to the program.

Design

Partners of the Border Health Strategic Initiative (Border Health ¡SI!) collaboratively developed a culturally relevant diabetes outreach and education program
The model included a five-week series of free diabetes education classes that assisted participants in gaining the knowledge and skills necessary to be physically active, control diet, monitor blood sugar, take medications and be aware of complications
- Two-hour classes held once a week
  - Santa Cruz had an open door program, classes were available on a rotating basis, participants attended in any sequence, as often as they wished, class size was maintained at 20 participants
  - Yuma recruitment was done for each round of classes and participants were encouraged to complete the program during this time period, class sizes were up to 40 people.
Central to the model was the use of community health workers (promotores de salud) to conduct outreach, participate in patient education and provide individual support: Promotoras also assisted participants in accessing health insurance, medications and other social services
CDE from county hospitals were used to facilitate classes and train promotoras in diabetes care and work individually with participants using the American Diabetes Association (ADA) Standards of Care
Self-management practices were assessed through pre-and follow-up questionnaires administered by the promotoras prior to initiation in the program and six months after the completion of the classes included demographics and healthy history, self-management practices, including diet, physical activity, foot care and regular glucose monitoring, also their most recent visits to their doctor and whether they had received diabetes health exams in the past year.

Intervention

Five-week series of free diabetes education classes that assisted participants in gaining the knowledge and skills necessary to be physically active, control diet, monitor blood sugar, take medications and be aware of complications.

Statistical Analysis

Paired T-tests were performed on pre- and post-data.

Data Collection Summary:

Timing of Measurements

Initiation of classes
Upon graduation from program
Six months after completion of the classes.

Dependent Variables

Random blood glucose
Blood pressure
Weight
HbA1c.

Independent Variables

Education.

Description of Actual Data Sample:

Initial N

Yuma
- 376 enrolled (66% female, N=250)
- 81%, N=306 graduated
- 79%, N=243 were reached for the follow-up interview
Santa Cruz
- 406 enrolled (70% female, N=284)
- 33%, N=135 graduated
- 30%, N=40 were reached for follow-up.

Attrition (Final N)

Yuma: 243 were reached for the follow-up interview (79%)
Santa Cruz: 40 were reached for follow-up (30%).

Age

Yuma: 70%, N=262 were older than 50 years old
Santa Cruz: 50%, N=203 were older than 50 years old.

Ethnicity

Hispanic.

Other Relevant Demographics

Majority did not graduate from high school.

Anthropometrics

Yuma: 174.3 lbs
Santa Cruz: 184.6 lbs.

Location

Arizona border; Yuma and Santa Cruz.

Summary of Results:

Significant decrease in the average random blood glucose measurement among participants in both programs
Both programs achieved modest but significant decreases in diastolic blood pressure among all participants
In Yuma there was a significant decrease in HbA1c from 9.4 to 8.7 among those who initiated the program with a HbA1c over 6.9
A significant portion of participants in both counties reported increasing self-management behaviors, including diet, foot care and glucose monitoring
In Santa Cruz, the percentage of individuals following diabetes diet increased significantly.

Changes in Self-Reported Diabetes Self-Management Outcomes

	Santa Cruz County N=40		Yuma County N=243
	Pre-program	Post-program	Pre-program	Post-program
Exercise regularly	50	70*	67	83***
Follows diet	45***	80***	Data not complete
Checks feet regularly	60	88**	86	98***
Monitors blood sugar	38	63	51	96***
Ever had HbA1c	33	45	53	96***
Knows what HbA1c is	40*	40*	22	64***
Ever had eye exam	33	47	57	91*

* P<0.06
** P<0.01
*** P<0.001.

In Yuma the in-depth interview six months after completion of the program demonstrated that participant attitude toward diabetes care changed from ignorance and fear to acceptance and control.

Author Conclusion:

Program participants achieved significant improvement in self-management behaviors and HbA1c, random blood glucose and blood pressure.

Funding Source:

Government:

Health Resources and Services Administration Rural Health Outreach Grant

Reviewer Comments:

The two different sites did not have equal resources or equal educators: Santa Cruz had a CDE teaching classes and Yuma had promotores teaching classes under the supervision of a CDE
The two programs were not managed or structured in the exact same way
Santa Cruz had been initiated several years prior to Border Health ¡SI!: Local providers were aware of the benefits of the program and regularly referred their patients to the classes
Evaluation efforts were hindered by lack of resources which resulted in gaps in data: Yuma's data set was much more complete.

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?	No
	2.2.	Were criteria applied equally to all study groups?	???
	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)	N/A
	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?	Yes
	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?	???
	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?	N/A
	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.)	N/A
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	No
	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?	N/A
	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
	6.4.	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?	Yes
	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)?	N/A
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	N/A
	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