EAL

MNT: RDN in Medical Team (2015)

Citation:

Bastiaens H, Sunaert P, Wens J, Sabbe B, Jenkins L, Nobels F, Snauwaert B, Van Royen P. Supporting diabetes self-management in primary care: Pilot-study of a group-based programme focusing on diet and exercise. Prim Care Diabetes. 2009; 3(2): 103-109.

PubMed ID: 19264568

Study Design:

Before-After Study

Class:

D - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

To evaluate the feasibility and acceptability of structured diabetes self-management education in a primary care setting
To examine the long-term effects of the program on emotional distress, HbA1c, BMI and actual behavior (dietary habits and physical activity).

Inclusion Criteria:

People with type 2 diabetes living in the study area
Receiving less than two insulin injections a day
Participants signed an informed consent.

Exclusion Criteria:

People without type 2 diabetes
Receiving more than two insulin injections a day.

Description of Study Protocol:

Recruitment

The study was advertised at a community information meeting and in local papers. Patients could also be referred by their general practice physicians or be invited following one-to-one educational sessions.

Design

Before-and-after study
The study was a longitudinal intervention study with pre-measures and post-measures. The empowerment-based, theory-driven education program was developed by a team of healthcare providers and focused on behavior assessment, goal-setting, problem solving and tailored information. The program consisted of five two-hour sessions every two weeks. It was led by a trained diabetes specialist nurse, with assistance from a dietitian and psychologist. The coaches utilized a written script, which defined key points rather than a fixed program, to guide the sessions. Patients were asked to assess their actual behavior using a three-day food diary and a pedometer.

Blinding Used

Implied with measurements.

Intervention

Content of the Group Program

Session	Providers	Key Points	Homework
One	Educator and psychologist	Introduction: Aims of the program Explore motivation to participate Explore own expectations Basic information on diabetes and lifestyle.	Think about taking up self-management of diet and exercise.
Two	Educator and dietitian (physical activity counselor)*	Introduction of goal setting (with examples/ experiences of the group) Basic information on healthy food and exercise How to assess actual behavior.	Assessment (food diary/pedometer) Think about an individual goal.
Three	Educator (physical activity counselor)*	Feedback on behavior (assessment) Setting concrete goals Making an action plan.	Make an action plan Think about barriers/solutions Start change.
Four	Educator and dietitian	Discussing concrete goals and action plans Discussing barriers/solutions Feedback on food diary.	Implement actual change Problem solving.
Five	Educator and psychologist	Discussing experiences Discussing barriers and solutions Problem solving Discussing concrete goals and action plan for following three months and confidence.	Same as session four.
Follow-up session	Educator and dietitian	Discussing experiences Adjusting goals/action plans Problem solving.	Same as session four.

*The physical activity counselor was only present in Group One and Group Two. From them on, she became an expert whom the educator contacted for advice and information.

Statistical Analysis

Non-parametric tests (Wilcoxon signed ranks two-tailed) were used for calculating significance levels of changes in PAID-score as well as HbA1c because of the small numbers and non-normal distribution of outcome variables (Shapiro Wilk, P<0.05)
Paired-sample T-tests were used for BMI (more than 30 pairs and Shapiro Wilk, P=0.262)
Non-normal distribution of outcome variables (Shapiro Wilk, P<0.05).

Data Collection Summary:

Timing of Measurements

Patients completed measures on dietary habits, physical activity and emotional distress before starting the program and again 12 and 18 months post-attendance. Values of HbA1c and BMI were collected at the same intervals.
At the end of the fifth session, a short evaluation questionnaire was distributed.

Dependent Variables

Feasibility and acceptability of program: At the end of the fifth session, a short evaluation questionnaire was distributed. The questionnaire focused on practical issues (time, duration and number of sessions). Participants were also asked if they felt the program was helpful and what they found helpful.
Emotional distress: The Problem Aria in Diabetes Scale (PAID) captures the patient's perspective on current emotional burden of diabetes and its treatment. The PAID produces a total score ranging from zero to 100, where a higher score indicates greater emotional distress.
HbA1c: Self-reported
BMI: Self-reported
Dietary habits: Patients completed a brief food frequency questionnaire, containing nine questions on overall eating behavior (intake of vegetables, fruit, bread, potatoes, rice, pasta, fat, having breakfast and the use of snacks)
Physical activity: Patients completed the International Physical Activity Questionnaire (IPAQ), which provides a comprehensive evaluation of daily physical activity habits.

Independent Variables

The empowerment-based, theory-driven education program was developed by a team of healthcare providers and focused on behavior assessment, goal-setting, problem solving and tailored information. The program consisted of five two-hour sessions every two weeks. It was led by a trained diabetes specialist nurse, with assistance from a dietitian and psychologist. The coaches utilized a written script, which defined key points rather than a fixed program, to guide the sessions. Patients were asked to assess their actual behavior using a three-day food diary and a pedometer.
Session attendance varied from 63% to 100%
The mean attendance rate per participant was 4.9 sessions (out of six). A total of 44% attended all six sessions.
A total of 34% participants also attended individual sessions.

Description of Actual Data Sample:

Initial N: N=44 (23 male, 21 female)
Attrition (final N): N=44
Age: Mean age of 66±6 years
Other relevant demographics: A total of 96% were retired
Anthropometrics: Mean BMI (±SD) was 28.6±18kg/m².

Summary of Results:

Key Findings

The number and duration of sessions met participants' expectations
Participants valued the presence of the same educator in each session and the support of complementary healthcare providers
The program attributes identified as helpful by participants can be categorized into three groups:
- Many patients felt supported, no longer alone and they valued being able to learn from peers and exchange experiences
- Attending the group program motivated them to adhere to their therapy
- Patients were very positive about the amount of useful and concrete information on diabetes and nutrition.

	Results at 12 Months						Results at 18 Months
	T0	T12m	Negative Ranks T12	Positive Ranks T12>T0	Ties T12=T0	Significance Levels of Change (P)*	T0	T18m	Negative Ranks T18	Positive Ranks T18>T0	Ties T18=T0	Significance Levels of Change (P)*
BMI (kg/m²)	29.0	28.5				0.044	29.3	28.8				0.043
HbA1c (percent)	74	6.8	14	5	2	0.040	7.4	7.3	11	10	0	NS
PAID-score	28	18	18	5	0	0.006	26	21	12	8	2	NS

Paired-sample T-test was used to calculate significance levels of change in BMI. Wilcoxon signed ranks two-tailed test was used to calculate significance levels of changes in HbA1c and PAID-score.

BMI decreased modestly at 12-month and at 18-month follow-up
Mean HbA1c significantly decreased at 12-month follow-up. No statistically significant difference was observed at 18-month follow-up.
The PAID-score decreased at 12-month follow-up. No significant difference was observed at 18-month follow-up.

Other Findings

Based on observations of the diabetes specialist nurse, patients made small but concrete changes in their dietary and physical activity behavior. Effects on actual behavior could not be confirmed based on the analysis of the food frequency and IPAQ questionnaires.

Author Conclusion:

Implementing a group-based diabetes self-management education program at the community level in a primary care setting is feasible and effective, but further research is needed to explore the actual education process in greater depth.

Funding Source:

Government:

The Belgian Government (National Health Insurance Institute)

Reviewer Comments:

Small study
Some participants attended individual sessions in addition to the group program
Participants did not attend all group sessions
Participant experience and outcomes dependent on other participants and group dynamics
Content of group sessions variable
HbA1c and BMI were self-reported
Limited follow-up data
Good discussion about study limitations.

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?		N/A
	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?	N/A
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	N/A
	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?	N/A
	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%.)	N/A
	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?		Yes
	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.)	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?	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