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primary care diabetes 8 ( 2 0 1 4 ) 23–29
Contents lists available at ScienceDirect
Primary Care Diabetes
journal homepage: http://www.elsevier.com/locate/pcd
Original research
Action research led to a feasible lifestyle
intervention in general practice for people with
prediabetes
Helle Terkildsen Maindala,∗
, Ane Bondeb
, Jens Aagaard-Hansenb
a Section for Health Promotion and Health Services and Section of General Practice, Department of Public Health,
Aarhus University, Denmark
b Steno Health Promotion Centre, Steno Diabetes Centre, Gentofte, Denmark
a r t i c l e i n f o
Article history:
Received 27 March 2013
Received in revised form
7 November 2013
Accepted 28 November 2013
Available online 19 December 2013
Keywords:
Action research
Feasibility
General practice
Health behaviour
Health services research
Lifestyle
Prediabetes
a b s t r a c t
Aim: To develop and pilot a feasible lifestyle intervention for people with prediabetes tailored
for general practice. The study was designed to explore (i) what resources and competencies
would be required and (ii) which intervention components should be included.
Methods: In the first of two action research cycles various interventions were explored in
general practice. The second cycle tested the intervention described by the end of the first
cycle. In total, 64 patients, 8 GPs and 10 nurses participated.
Results: An intervention comprising six consultations to be delivered during the first year
after identified prediabetes was found feasible by the general practice staff in terms of
resources. Practice nurses possessed the adequate competences to undertake the core part
of the intervention. The intervention comprised fixed elements according to structure, time
consumption and educational principles, and flexible elements according to educational
material and focus points for behaviour change. Clinical relevant reductions in patients’
BMI and HbA1c were found.
Conclusion: A prediabetes lifestyle intervention for Danish general practice with potential
for diabetes prevention was developed based on action research. The transferability of the
developed intervention to other general practices depends on the GPs priorities, availability
of practice nurses to deliver the core part, and the remuneration system for general practice.
The long-term feasibility in larger patient populations is unknown.
© 2013 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.
1. Introduction
Lifestyle interventions are effective in delaying the onset of
type 2 diabetes (T2D) in large randomized trials, but the
translation from research to routine primary care remains a
∗
Corresponding author at: Section for Health Promotion and Health Services, Department of Public Health, Aarhus University, Bartholins
Allé 2, 8000 Aarhus C, Denmark. Tel.: +45 87 16 79 29; fax: +45 86 12 47 88.
E-mail addresses: htm@alm.au.dk (H.T. Maindal), AHBO@steno.dk (A. Bonde), JXAH@steno.dk (J. Aagaard-Hansen).
challenge [1]. The effective interventions have been developed
and tested in selected populations, often among motivated
volunteers without comorbidities [2–7]. Furthermore, the
effective interventions were usually complex, conducted in
optimal conditions and with substantial resource alloca-
tion. Less resource-intensive interventions, based on selected
1751-9918/$ – see front matter © 2013 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.pcd.2013.11.007
24 primary care diabetes 8 ( 2 0 1 4 ) 23–29
components of some of the more effective programmes,
have been conducted in primary care settings. In 2010 Euro-
pean practice guideline for prevention of diabetes were
developed recommending concepts and structures for inter-
vention programs as well as a new behavioural change model
was developed as part of the IMAGE project summariz-
ing behavioural strategies for successful sustained lifestyle
change [8,9]. Further the National Institute for Health and
Clinical E developed guidelines for preventing type 2 diabetes
[10]. The guidelines emphasised prevention at different levels
using existing local interventions.
Despite guidelines findings are still inconsistent and most
often rely on local actors such as community organisations
like the YMCA [11–15]. An optimised lifestyle programme for
T2D or prediabetes was evaluated in “real-life” primary health-
care centres in Holland [16], but the programme was no more
effective than routine care. The involvement and participation
of the mutually interdependent professionals, patients and
communities seems to be crucial for successful implemen-
tation of diabetes prevention strategies in “real life” primary
care [17,18].
The aim of this study was to develop and pilot a feasi-
ble lifestyle intervention for people with prediabetes tailored
for general practice. The study was designed to explore (i)
what resources and competencies would be required and (ii)
which intervention components should be included. The term
prediabetes is a common term for hyperglycaemic condition
including impaired fasting glucoses, impaired glucoses toler-
ance and increased HbA1c below diabetes thresholds.
2. Methods
2.1. Setting
In Denmark, general practice is the primary entry point into
the health care system, and this tax-funded health care sys-
tem ensures free access for all citizens to general practice
services. T2D is predominantly diagnosed and treated by
GPs [19]. Clinical guidelines advocate that GPs should pre-
vent diabetes and inform patients about healthy lifestyle,
but no specific recommendation is provided [20]. Danish GPs
operate as independent contractors within the public health
service and are remunerated based on a combination of fee-
for-service (2/3) and capitation basis (1/3) [19]. Approximately
60% of GPs employ practice nurses who provide a variety of ser-
vices depending on their competencies and the organisation
of the clinic.
2.2. Action research design
Action research was chosen to tailor the intervention and
to ensure involvement of the general practice staff. Action
research is usually conducted in two cycles or phases, the first
being open and exploratory, the second more focused [18,21].
The British Medical Research Council’s framework for the
development and evaluation of complex interventions sup-
port these two phases: a first modelling phase and a second
testing phase to evaluate the feasibility of what was modelled
in the first phase [22]. Accordingly, we conducted two action
Fig. 1 – Action research design, timeline, workshops and
interviews used in the development of a prediabetes
intervention.
research phases, the first for modelling and the second for
testing. Workshops were conducted with the health profes-
sionals at four stages – in the beginning and the end of each
phase. In addition, each practice was visited and interviewed
three times during the study period – two with each during the
first phase and one with each of the remaining six practices
during the second phase, adding up to a total of 22 interviews
(Fig. 1).
2.3. Researchers
The research team, comprising the three authors of this paper,
had expertise in health promotion, intervention research, dia-
betes and general practice. They worked collaboratively with
the general practice staff to develop and test the intervention.
2.4. Recruitment of GPs and staff
Purposeful selection of general practices for the study was
chosen, as commitment to close collaboration between par-
ticipants and researchers in the intervention development
process was crucial [21]. A total of eight general practices
were recruited in collaboration with the coordinators of the
two largest regional diabetes committees in Denmark. All
had a special interest in diabetes which was a prerequisite
for engaging in the study. All the practices employed practice
nurses, although this was not a criterion for participation. The
primary care diabetes 8 ( 2 0 1 4 ) 23–29 25
Table 1 – Recruitment of patients with prediabetes in
eight general practices.
Practice Cycle 1 Cycle 2 Total
Practice A 4 8 12
Practice Ba
5 0 5
Practice Ca
5 0 5
Practice D 7 3 10
Practice E 5 3 8
Practice F 4 2 6
Practice G 5 4 9
Practice H 4 5 9
Total 39 25 64
a
Practice dropped out in cycle 2 for administrative reasons.
participants included eight GPs and ten practice nurses as
one GP from a large clinic entered three nurses to the project.
In the second phase, two GPs dropped out for administrative
reasons. Prior to the study, none of the included practices had
procedures for prediabetes. Mid-way through the study, an
attempt was made to recruit general practices without nurses
– but without success.
2.5. Recruitment of patients
GPs were asked to recruit 4–5 patients in each phase, with
whom they were going to develop the intervention. The
inclusion criteria were: approximately 40–65 years of age, at
high risk of prediabetes (BMI > 30 kg/m2) and/or prediabetes
diagnosed by any of the following: raised fasting glucose
(BG > 6.0 mmol/l), glucose intolerance (by the standard diag-
nostic criteria) or ‘glycosylated haemoglobin’ (HbA1c) 6.0–6.4%.
No exclusion criteria, such as comorbidity were defined. The
GPs chose different recruitment procedures. Two performed
this systematically by searching on the above criteria in their
own patient databases. The remaining did it by recalling rele-
vant patients seen within the last year. The identified patients
received a letter or a phone call from the nurse with an invi-
tation to a consultation about their diabetes risk and lifestyle.
The recruitment procedures resulted in 39 patients from 8
practices in the first phase and 25 patients from 6 practices
in the second phase (Table 1). The two GPs that recruited sys-
tematically found that less than 50% of the identified patients
accepted the invitation to attend.
2.6. Data generation and analysis
Patient data were collected by practice staff and handed over
to the research team in an anonymous form. A descriptive
analysis of the patients’ characteristics and comparison of BMI
and HbA1c measurements at 0 and 3 months by paired t-tests
was carried out using the statistical work package Stata 11.0.
Practice data were collected by the researchers during the
interviews and workshops with the GPs and the practice
nurses. The researchers took minutes from the workshops and
interviews.
A preliminary analysis was performed by the researchers
after each series of interviews and after each workshop. The
interviews were analysed searching for statements according
to the specific topic for the workshops in the modeling and
testing phases. Data were assessed by the three researchers
(JAH, AHB and HTM) and any differences in interpretation were
resolved by mutual agreement before the workshops. The find-
ings were then presented to the health professionals in the
next workshop for further development. The intervention pre-
sented, as a result of the study, was agreed upon in the final
workshop.
2.7. Ethical and legal aspects
The study was conducted in full compliance with the Helsinki
Declaration. All patient information from the practices was
handled anonymously and there was no direct patient contact.
Consequently, permission from the Regional Research Ethics
Committee was not required in accordance with Danish law
[23]. It was neither necessary to obtain patient consent, nor
achieve permission from the Danish Data Protection Agency
to store the data. GPs sought and achieved authorisation to
participate in the study from the Danish Medicines Agency, as
Steno Diabetes Centre is a subsidiary of the pharmaceutical
company Novo Nordisk A/S.
3. Results
3.1. Results from the first phase
All practices chose to provide the lifestyle intervention as a
series of consultations with the practice nurse as the primary
human resource. The GPs role was in the initial and then final
consultation in order to conclude with the patient and mark
the termination of the intervention.
All practices included the following themes in their con-
sultations: motivation, prediabetes, diet and physical activity.
Other topics, such as smoking and alcohol were dealt with
when relevant. All the practice nurses used written mate-
rial about lifestyle to support the consultations. This included
published booklets and pamphlets from the Danish Health
and Medication Authorities that are available for patients and
practitioners either free from the homepage or at very low
cost. Some of them also used self-made registration forms for
24 h food and beverage intake and lists of local opportunities
for physical exercise. All practices emphasised an individ-
ual approach tailored to the needs and the risk profile of the
patient.
In two cases, the interventions differed from a traditional
consultation. One GP experimented using a walking fitness
test as a tool with some patients. One practice nurse phoned
the patients to support their efforts. However, these activi-
ties were time consuming and therefore left out in the second
phase.
The practices had provided from one to five consultations
and spent between 30 and 150 min per patient during the first
intervention period. The duration of the consultations varied,
as did the intervals between them. Therefore, specific ques-
tions for the next phase were: what would be the number of
consultations in the final recommended lifestyle intervention,
the themes for each one, the spacing between them and the
total minutes to spend?
26 primary care diabetes 8 ( 2 0 1 4 ) 23–29
3.2. Results at the end of the second phase: the
suggested lifestyle intervention
By the end of the second phase, the researchers and the health
professionals agreed on a lifestyle intervention for the pre-
vention of T2D in people with prediabetes in Danish general
practices as outlined in Fig. 2.
The recommended intervention consists of five consulta-
tions in a span of approximately 6 months and a final status
after 1 year. The initial and final consultations will be under-
taken by the GP as he/she has the technical and economical
mandate to initiate and terminate treatment and follow-up
according to the medical condition. The core of the lifestyle
intervention is undertaken by the practice nurse. Total time
required, including the initial consultation with the diagno-
sis and the final status consultation with the GP is 110 min
(15 + 30 +15 + 15 + 15 + 20). The intervention will cover the fol-
lowing themes: (1) prediabetes, diabetes and prevention, (2)
motivation, willingness to change, barriers, (3) food and bev-
erage consumption, (4) movement and exercise and (5) goal
setting and action plans with small steps.
The first theme will be covered by the GP in the initial con-
sultation. Motivation will be included in all the consultations
with the practice nurse, with focus on either diet or exercise
or both, according to the patients’ motivation and risk profile.
Goal setting will also be included in the core intervention. The
educational approach will be supportive to the patient’s goals
and to define small achievable steps of behavioural change
in commonly agreed action plans. The use of supportive edu-
cational material would vary according to what the practice
nurse was familiar with and preferred. Especially one book-
let was found very useful by the practice nurses who ordered
“Small steps to weight loss – and keeping it” published by the
Danish Health and Medical authorities. It is a self-help guide
based on the official recommendations and newest evidence
on the importance of diet and physical activity for weight reg-
ulation and psychological aspects of behavioural change. The
booklet does not contain specific references, but The Stages of
Change Theory by Prochaska and DiClimente and Motivational
Interviewing by Miller and Rollnick is part of the theoretical
foundation.
3.3. Patient characteristics and 3 month changes in
HbA1c and BMI
There were 64 participating patients with a mean age of 58
years (SD = 8.5); 61% were women. The mean HbA1c at base-
line was 6.0% (SD = 0.3) and the mean BMI was 32.1 (SD = 6.1).
After 3 months, 43 patients (67%) provided data for the HbA1c
analysis and 46 patients (72%) for the BMI analysis. Follow up
results revealed a significant reduction in HbA1c of 0.14% (95%
CI: 0.06–0.21) and a significant decrease in BMI of 0.59 km/m2
(CI 0.27–0.91) (Table 2).
3.4. Other findings
During the final interviews and the last workshop, the GPs
and practice nurses expressed that they had gained more
confidence in the patient-centred approach during the
action research process. They found themselves asking more
open-ended questions and they tended to listen more, and
gave less advice. The nurses explained that they were now able
to make a shift from an explaining and counselling role in the
first consultations to a facilitating and supporting role in the
following. One GP said that she had never been as “quiet and
laid-back with such success”. The practitioners expressed how
taking lifestyle more seriously had given them the courage to
be more persistent. Previous to the project it had been easier to
“give up”. They all found that the competencies obtained from
this study in relation to prediabetes were equally relevant for
other risk conditions and behavioural changes in general.
It arose as an issue several times during the study period
that “one size does not fit all”. Six consultations may be suit-
able for the “average” patient to change lifestyle, but some
patients require a longer and more intensive intervention.
This was the case when social, mental or medical issues in
addition to prediabetes were present.
Another issue was the term prediabetes. Prior to this study,
the general practice staff had not considered this term for
hyperglycaemic conditions, but called it “grey zone” or “high
risk of diabetes”. Now they preferred “prediabetes”, as they
found it useful in assisting them to get messages across to
the patients, and they found that for some patients, the diag-
nosis of “prediabetes” was a cue to action, as diabetes was a
condition they wanted to avoid.
4. Discussion
This study, employing action research, led to a feasible short
lifestyle intervention for people with prediabetes being devel-
oped in general practices with practice nurses employed.
The feasibility was gained through the active participation
of practice staff in the development. The developed interven-
tion comprised a standardised package of themes, educational
principles and a time frame of 6 months (110 min). The main
themes to address were motivation, food, exercise and goal
setting with small steps. These themes should be covered
in a flexible and patient-centred way, choosing educational
material and the choice of health behaviours focus accord-
ing to individual needs. The first and the last consultation
should be delivered by the GP and the core four by the practice
nurse. Only in one practice did the GP want to take all consul-
tations. The intervention was developed and tested with 64
patients and showed a positive short-term effect on HbA1c
and BMI, which could be interpreted as proxies of progression
to type 2 diabetes. Despite the small amount of participants
due to the action research design the results are promising
[21]. The intervention are to some extent following the recom-
mended components from the European and Nice guidelines
as it target both diet and physical activity, mobilize social, local
support, involve behaviour change techniques, and provide
frequent contacts [8].
Other prevention studies targeted people with prediabetes
under “real life” conditions and have also showed an effect
[11–15]. As opposed to previous studies that are generally not
very specific about the resource consumption [24], the present
study focused especially on this issue as part of the “real-life”
adaptation. Evans et al. [25] made an attempt similar to ours by
tailoring a preventive intervention involving both the patients
primary care diabetes 8 ( 2 0 1 4 ) 23–29 27
Fig. 2 – The feasible prediabetes lifestyle intervention developed through action research in general practice.
and the health professionals. In line with Evans, we found that
focusing on the patient’s own knowledge, education and moti-
vation was a valuable approach. Thus, our study revealed a
significant need for a patient-driven approach, where knowl-
edge and education should be delivered in order to enhance
the informed decision-making of the individual.
4.1. Methodological issues
From a methodological perspective, the action research
approach proved very useful. The health professionals from
general practices were engaged in a genuine collaboration
with the researchers in order to develop a locally adapted
intervention. The present study illustrates the positivity of
how additional focus on the local context and involvement
of local stakeholders in the developmental stage of a complex
intervention can create comprehension about realistic issues
associated with the intervention, according to the newest
guidelines for developing effective interventions in primary
care from UK [22]. The initial research agenda and activities
were initially prepared by the researchers, but as the study
unfolded, the planning of activities was shared by researchers
and practitioners, and in this respect in line with the nature of
action research [18,21]. When it became apparent that the var-
ious practices had more or less structured the intervention in
the same way during the first cycle, mutual agreements were
made to promote it as the appropriate way to organise lifestyle
intervention in general practice. The fact that the health pro-
fessionals perceived the developed lifestyle intervention as
realistic in their daily practice and experienced ownership,
reiterated that the action research had been conducted in
a collaborative and equitable manner. Potential obstacles to
social research, such as predominantly negative posture, as
seen elsewhere in healthcare according to Albert et al. were
not present [26].
4.2. Implications for practice
The suggested intervention may be integrated in the exist-
ing structures of general practices in countries other than
Denmark, provided that practice nurses are employed. It does
not require acquisition of any equipment, as the health profes-
sionals themselves were the main resources. The educational
material used was extracted from existing material or self-
made.
The participating GPs were recruited based on their interest
in diabetes, which we considered fundamental for their active
involvement in the study. However, it is also a major limitation
regarding the transferability to GPs with other main interests.
It is common knowledge that GPs’ attitudes together with
perceived external control factors (time and cost), influence
the priority on management of behavioural risk factors [27]. By
the end of the study period, the economic remuneration agree-
ment between the Health Authorities and the General Practice
Association changed and does not at present favour consulta-
tion about lifestyle. This may limit the potential for targeting
prediabetes in the general practice setting on a large scale,
as only GPs with a previous vested and positive attitude to
lifestyle modification may find a way to elicit remunerated for
these consultations. For large scale studies in heterogeneous
practices, a variety of intervention models adjusted to differ-
ent contexts are recommended, or more radically a redesign
Table 2 – Patient characteristics at inclusion, and differences in HbA1c and BMI from 0 to 3 month follow-up.
Characteristics N Three months difference N P-value
(From-to-) (95% CI)
Sex, female (%) 39 (61) 64
Age, year, mean (SD) 58.3 (8.5) 64
HbA1c (%) mean (SD) 6.0 (0.3) 54 6.02–5.88 0.14 (0.06–0.21) 43 0.001
BMI (kg/m2
) mean (SD) 32.1 (6.1) 62 31.90–31.31 0.59 (0.27–0.91) 46 0.001
28 primary care diabetes 8 ( 2 0 1 4 ) 23–29
of the health service models. Although the Danish primary
health care system is less driven by commercial interests
than in most other countries in the world. Further research
is needed to develop effective and cost-effective individual-
based real-world prevention strategies also beyond alternative
needs assessments and settings, alongside consideration of
population-based interventions to change behavioural norms,
as recommend by the European guidelines [9,10].
5. Conclusion
An action research approach proved useful to involve gen-
eral practitioners and practice nurses in the development and
testing of a lifestyle intervention for people with prediabetes
tailored for general practice. The developed intervention of six
consultations during 1 year, in total 110 min showed signifi-
cant short-term impact on HbA1c and BMI. The intervention
is deemed feasible for a minority of engaged general practices
with a particular interest for diabetes, but not necessarily for
general population coverage.
Authors’ contributions
JAH, AHB and HTM carried out the study. Together they
designed the study and conducted the interviews and work-
shops. All authors were involved in the manuscript editing
and the interpretation of results. AHB and HTM wrote the first
drafts of the manuscript whilst HTM wrote the final paper,
which was approved by AHB and JAH.
Conflict of interest
The Steno Health Promotion Centre is funded by Novo Nordisk
A/S and the Novo Nordisk Foundation. The authors do not
perceive this as a conflict of interests in this study.
Acknowledgements
Our appreciation goes to the participating GPs and practice
nurses for their engagement in the action research process. We
wish to thank GP Lars Dudal Madsen and GP Jens Damsgaard
from the Regional Diabetes Committees for their endorse-
ment. We thank our colleagues at the Steno Diabetes Centre
and Aarhus University, Department of Public Health for invalu-
able comments in different phases of the study period.
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and Understanding in Pre-diabetes), Diabet. Med. 24 (7)
(2007) 770–777.
[26] M. Albert, S. Laberge, B.D. Hodges, G. Regehr, L. Lingard,
Biomedical scientists’ perception of the social sciences in
health research, Soc. Sci. Med. 66 (12) (2008) 2520–2531.
[27] A.J. Ampt, C. Amoroso, M.F. Harris, S.H. McKenzie, V.K. Rose,
J.R. Taggart, Attitudes, norms and controls influencing
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Fam. Pract. 10 (2009) 59.

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art-STENO-GP-prediab

  • 1. primary care diabetes 8 ( 2 0 1 4 ) 23–29 Contents lists available at ScienceDirect Primary Care Diabetes journal homepage: http://www.elsevier.com/locate/pcd Original research Action research led to a feasible lifestyle intervention in general practice for people with prediabetes Helle Terkildsen Maindala,∗ , Ane Bondeb , Jens Aagaard-Hansenb a Section for Health Promotion and Health Services and Section of General Practice, Department of Public Health, Aarhus University, Denmark b Steno Health Promotion Centre, Steno Diabetes Centre, Gentofte, Denmark a r t i c l e i n f o Article history: Received 27 March 2013 Received in revised form 7 November 2013 Accepted 28 November 2013 Available online 19 December 2013 Keywords: Action research Feasibility General practice Health behaviour Health services research Lifestyle Prediabetes a b s t r a c t Aim: To develop and pilot a feasible lifestyle intervention for people with prediabetes tailored for general practice. The study was designed to explore (i) what resources and competencies would be required and (ii) which intervention components should be included. Methods: In the first of two action research cycles various interventions were explored in general practice. The second cycle tested the intervention described by the end of the first cycle. In total, 64 patients, 8 GPs and 10 nurses participated. Results: An intervention comprising six consultations to be delivered during the first year after identified prediabetes was found feasible by the general practice staff in terms of resources. Practice nurses possessed the adequate competences to undertake the core part of the intervention. The intervention comprised fixed elements according to structure, time consumption and educational principles, and flexible elements according to educational material and focus points for behaviour change. Clinical relevant reductions in patients’ BMI and HbA1c were found. Conclusion: A prediabetes lifestyle intervention for Danish general practice with potential for diabetes prevention was developed based on action research. The transferability of the developed intervention to other general practices depends on the GPs priorities, availability of practice nurses to deliver the core part, and the remuneration system for general practice. The long-term feasibility in larger patient populations is unknown. © 2013 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved. 1. Introduction Lifestyle interventions are effective in delaying the onset of type 2 diabetes (T2D) in large randomized trials, but the translation from research to routine primary care remains a ∗ Corresponding author at: Section for Health Promotion and Health Services, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000 Aarhus C, Denmark. Tel.: +45 87 16 79 29; fax: +45 86 12 47 88. E-mail addresses: htm@alm.au.dk (H.T. Maindal), AHBO@steno.dk (A. Bonde), JXAH@steno.dk (J. Aagaard-Hansen). challenge [1]. The effective interventions have been developed and tested in selected populations, often among motivated volunteers without comorbidities [2–7]. Furthermore, the effective interventions were usually complex, conducted in optimal conditions and with substantial resource alloca- tion. Less resource-intensive interventions, based on selected 1751-9918/$ – see front matter © 2013 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.pcd.2013.11.007
  • 2. 24 primary care diabetes 8 ( 2 0 1 4 ) 23–29 components of some of the more effective programmes, have been conducted in primary care settings. In 2010 Euro- pean practice guideline for prevention of diabetes were developed recommending concepts and structures for inter- vention programs as well as a new behavioural change model was developed as part of the IMAGE project summariz- ing behavioural strategies for successful sustained lifestyle change [8,9]. Further the National Institute for Health and Clinical E developed guidelines for preventing type 2 diabetes [10]. The guidelines emphasised prevention at different levels using existing local interventions. Despite guidelines findings are still inconsistent and most often rely on local actors such as community organisations like the YMCA [11–15]. An optimised lifestyle programme for T2D or prediabetes was evaluated in “real-life” primary health- care centres in Holland [16], but the programme was no more effective than routine care. The involvement and participation of the mutually interdependent professionals, patients and communities seems to be crucial for successful implemen- tation of diabetes prevention strategies in “real life” primary care [17,18]. The aim of this study was to develop and pilot a feasi- ble lifestyle intervention for people with prediabetes tailored for general practice. The study was designed to explore (i) what resources and competencies would be required and (ii) which intervention components should be included. The term prediabetes is a common term for hyperglycaemic condition including impaired fasting glucoses, impaired glucoses toler- ance and increased HbA1c below diabetes thresholds. 2. Methods 2.1. Setting In Denmark, general practice is the primary entry point into the health care system, and this tax-funded health care sys- tem ensures free access for all citizens to general practice services. T2D is predominantly diagnosed and treated by GPs [19]. Clinical guidelines advocate that GPs should pre- vent diabetes and inform patients about healthy lifestyle, but no specific recommendation is provided [20]. Danish GPs operate as independent contractors within the public health service and are remunerated based on a combination of fee- for-service (2/3) and capitation basis (1/3) [19]. Approximately 60% of GPs employ practice nurses who provide a variety of ser- vices depending on their competencies and the organisation of the clinic. 2.2. Action research design Action research was chosen to tailor the intervention and to ensure involvement of the general practice staff. Action research is usually conducted in two cycles or phases, the first being open and exploratory, the second more focused [18,21]. The British Medical Research Council’s framework for the development and evaluation of complex interventions sup- port these two phases: a first modelling phase and a second testing phase to evaluate the feasibility of what was modelled in the first phase [22]. Accordingly, we conducted two action Fig. 1 – Action research design, timeline, workshops and interviews used in the development of a prediabetes intervention. research phases, the first for modelling and the second for testing. Workshops were conducted with the health profes- sionals at four stages – in the beginning and the end of each phase. In addition, each practice was visited and interviewed three times during the study period – two with each during the first phase and one with each of the remaining six practices during the second phase, adding up to a total of 22 interviews (Fig. 1). 2.3. Researchers The research team, comprising the three authors of this paper, had expertise in health promotion, intervention research, dia- betes and general practice. They worked collaboratively with the general practice staff to develop and test the intervention. 2.4. Recruitment of GPs and staff Purposeful selection of general practices for the study was chosen, as commitment to close collaboration between par- ticipants and researchers in the intervention development process was crucial [21]. A total of eight general practices were recruited in collaboration with the coordinators of the two largest regional diabetes committees in Denmark. All had a special interest in diabetes which was a prerequisite for engaging in the study. All the practices employed practice nurses, although this was not a criterion for participation. The
  • 3. primary care diabetes 8 ( 2 0 1 4 ) 23–29 25 Table 1 – Recruitment of patients with prediabetes in eight general practices. Practice Cycle 1 Cycle 2 Total Practice A 4 8 12 Practice Ba 5 0 5 Practice Ca 5 0 5 Practice D 7 3 10 Practice E 5 3 8 Practice F 4 2 6 Practice G 5 4 9 Practice H 4 5 9 Total 39 25 64 a Practice dropped out in cycle 2 for administrative reasons. participants included eight GPs and ten practice nurses as one GP from a large clinic entered three nurses to the project. In the second phase, two GPs dropped out for administrative reasons. Prior to the study, none of the included practices had procedures for prediabetes. Mid-way through the study, an attempt was made to recruit general practices without nurses – but without success. 2.5. Recruitment of patients GPs were asked to recruit 4–5 patients in each phase, with whom they were going to develop the intervention. The inclusion criteria were: approximately 40–65 years of age, at high risk of prediabetes (BMI > 30 kg/m2) and/or prediabetes diagnosed by any of the following: raised fasting glucose (BG > 6.0 mmol/l), glucose intolerance (by the standard diag- nostic criteria) or ‘glycosylated haemoglobin’ (HbA1c) 6.0–6.4%. No exclusion criteria, such as comorbidity were defined. The GPs chose different recruitment procedures. Two performed this systematically by searching on the above criteria in their own patient databases. The remaining did it by recalling rele- vant patients seen within the last year. The identified patients received a letter or a phone call from the nurse with an invi- tation to a consultation about their diabetes risk and lifestyle. The recruitment procedures resulted in 39 patients from 8 practices in the first phase and 25 patients from 6 practices in the second phase (Table 1). The two GPs that recruited sys- tematically found that less than 50% of the identified patients accepted the invitation to attend. 2.6. Data generation and analysis Patient data were collected by practice staff and handed over to the research team in an anonymous form. A descriptive analysis of the patients’ characteristics and comparison of BMI and HbA1c measurements at 0 and 3 months by paired t-tests was carried out using the statistical work package Stata 11.0. Practice data were collected by the researchers during the interviews and workshops with the GPs and the practice nurses. The researchers took minutes from the workshops and interviews. A preliminary analysis was performed by the researchers after each series of interviews and after each workshop. The interviews were analysed searching for statements according to the specific topic for the workshops in the modeling and testing phases. Data were assessed by the three researchers (JAH, AHB and HTM) and any differences in interpretation were resolved by mutual agreement before the workshops. The find- ings were then presented to the health professionals in the next workshop for further development. The intervention pre- sented, as a result of the study, was agreed upon in the final workshop. 2.7. Ethical and legal aspects The study was conducted in full compliance with the Helsinki Declaration. All patient information from the practices was handled anonymously and there was no direct patient contact. Consequently, permission from the Regional Research Ethics Committee was not required in accordance with Danish law [23]. It was neither necessary to obtain patient consent, nor achieve permission from the Danish Data Protection Agency to store the data. GPs sought and achieved authorisation to participate in the study from the Danish Medicines Agency, as Steno Diabetes Centre is a subsidiary of the pharmaceutical company Novo Nordisk A/S. 3. Results 3.1. Results from the first phase All practices chose to provide the lifestyle intervention as a series of consultations with the practice nurse as the primary human resource. The GPs role was in the initial and then final consultation in order to conclude with the patient and mark the termination of the intervention. All practices included the following themes in their con- sultations: motivation, prediabetes, diet and physical activity. Other topics, such as smoking and alcohol were dealt with when relevant. All the practice nurses used written mate- rial about lifestyle to support the consultations. This included published booklets and pamphlets from the Danish Health and Medication Authorities that are available for patients and practitioners either free from the homepage or at very low cost. Some of them also used self-made registration forms for 24 h food and beverage intake and lists of local opportunities for physical exercise. All practices emphasised an individ- ual approach tailored to the needs and the risk profile of the patient. In two cases, the interventions differed from a traditional consultation. One GP experimented using a walking fitness test as a tool with some patients. One practice nurse phoned the patients to support their efforts. However, these activi- ties were time consuming and therefore left out in the second phase. The practices had provided from one to five consultations and spent between 30 and 150 min per patient during the first intervention period. The duration of the consultations varied, as did the intervals between them. Therefore, specific ques- tions for the next phase were: what would be the number of consultations in the final recommended lifestyle intervention, the themes for each one, the spacing between them and the total minutes to spend?
  • 4. 26 primary care diabetes 8 ( 2 0 1 4 ) 23–29 3.2. Results at the end of the second phase: the suggested lifestyle intervention By the end of the second phase, the researchers and the health professionals agreed on a lifestyle intervention for the pre- vention of T2D in people with prediabetes in Danish general practices as outlined in Fig. 2. The recommended intervention consists of five consulta- tions in a span of approximately 6 months and a final status after 1 year. The initial and final consultations will be under- taken by the GP as he/she has the technical and economical mandate to initiate and terminate treatment and follow-up according to the medical condition. The core of the lifestyle intervention is undertaken by the practice nurse. Total time required, including the initial consultation with the diagno- sis and the final status consultation with the GP is 110 min (15 + 30 +15 + 15 + 15 + 20). The intervention will cover the fol- lowing themes: (1) prediabetes, diabetes and prevention, (2) motivation, willingness to change, barriers, (3) food and bev- erage consumption, (4) movement and exercise and (5) goal setting and action plans with small steps. The first theme will be covered by the GP in the initial con- sultation. Motivation will be included in all the consultations with the practice nurse, with focus on either diet or exercise or both, according to the patients’ motivation and risk profile. Goal setting will also be included in the core intervention. The educational approach will be supportive to the patient’s goals and to define small achievable steps of behavioural change in commonly agreed action plans. The use of supportive edu- cational material would vary according to what the practice nurse was familiar with and preferred. Especially one book- let was found very useful by the practice nurses who ordered “Small steps to weight loss – and keeping it” published by the Danish Health and Medical authorities. It is a self-help guide based on the official recommendations and newest evidence on the importance of diet and physical activity for weight reg- ulation and psychological aspects of behavioural change. The booklet does not contain specific references, but The Stages of Change Theory by Prochaska and DiClimente and Motivational Interviewing by Miller and Rollnick is part of the theoretical foundation. 3.3. Patient characteristics and 3 month changes in HbA1c and BMI There were 64 participating patients with a mean age of 58 years (SD = 8.5); 61% were women. The mean HbA1c at base- line was 6.0% (SD = 0.3) and the mean BMI was 32.1 (SD = 6.1). After 3 months, 43 patients (67%) provided data for the HbA1c analysis and 46 patients (72%) for the BMI analysis. Follow up results revealed a significant reduction in HbA1c of 0.14% (95% CI: 0.06–0.21) and a significant decrease in BMI of 0.59 km/m2 (CI 0.27–0.91) (Table 2). 3.4. Other findings During the final interviews and the last workshop, the GPs and practice nurses expressed that they had gained more confidence in the patient-centred approach during the action research process. They found themselves asking more open-ended questions and they tended to listen more, and gave less advice. The nurses explained that they were now able to make a shift from an explaining and counselling role in the first consultations to a facilitating and supporting role in the following. One GP said that she had never been as “quiet and laid-back with such success”. The practitioners expressed how taking lifestyle more seriously had given them the courage to be more persistent. Previous to the project it had been easier to “give up”. They all found that the competencies obtained from this study in relation to prediabetes were equally relevant for other risk conditions and behavioural changes in general. It arose as an issue several times during the study period that “one size does not fit all”. Six consultations may be suit- able for the “average” patient to change lifestyle, but some patients require a longer and more intensive intervention. This was the case when social, mental or medical issues in addition to prediabetes were present. Another issue was the term prediabetes. Prior to this study, the general practice staff had not considered this term for hyperglycaemic conditions, but called it “grey zone” or “high risk of diabetes”. Now they preferred “prediabetes”, as they found it useful in assisting them to get messages across to the patients, and they found that for some patients, the diag- nosis of “prediabetes” was a cue to action, as diabetes was a condition they wanted to avoid. 4. Discussion This study, employing action research, led to a feasible short lifestyle intervention for people with prediabetes being devel- oped in general practices with practice nurses employed. The feasibility was gained through the active participation of practice staff in the development. The developed interven- tion comprised a standardised package of themes, educational principles and a time frame of 6 months (110 min). The main themes to address were motivation, food, exercise and goal setting with small steps. These themes should be covered in a flexible and patient-centred way, choosing educational material and the choice of health behaviours focus accord- ing to individual needs. The first and the last consultation should be delivered by the GP and the core four by the practice nurse. Only in one practice did the GP want to take all consul- tations. The intervention was developed and tested with 64 patients and showed a positive short-term effect on HbA1c and BMI, which could be interpreted as proxies of progression to type 2 diabetes. Despite the small amount of participants due to the action research design the results are promising [21]. The intervention are to some extent following the recom- mended components from the European and Nice guidelines as it target both diet and physical activity, mobilize social, local support, involve behaviour change techniques, and provide frequent contacts [8]. Other prevention studies targeted people with prediabetes under “real life” conditions and have also showed an effect [11–15]. As opposed to previous studies that are generally not very specific about the resource consumption [24], the present study focused especially on this issue as part of the “real-life” adaptation. Evans et al. [25] made an attempt similar to ours by tailoring a preventive intervention involving both the patients
  • 5. primary care diabetes 8 ( 2 0 1 4 ) 23–29 27 Fig. 2 – The feasible prediabetes lifestyle intervention developed through action research in general practice. and the health professionals. In line with Evans, we found that focusing on the patient’s own knowledge, education and moti- vation was a valuable approach. Thus, our study revealed a significant need for a patient-driven approach, where knowl- edge and education should be delivered in order to enhance the informed decision-making of the individual. 4.1. Methodological issues From a methodological perspective, the action research approach proved very useful. The health professionals from general practices were engaged in a genuine collaboration with the researchers in order to develop a locally adapted intervention. The present study illustrates the positivity of how additional focus on the local context and involvement of local stakeholders in the developmental stage of a complex intervention can create comprehension about realistic issues associated with the intervention, according to the newest guidelines for developing effective interventions in primary care from UK [22]. The initial research agenda and activities were initially prepared by the researchers, but as the study unfolded, the planning of activities was shared by researchers and practitioners, and in this respect in line with the nature of action research [18,21]. When it became apparent that the var- ious practices had more or less structured the intervention in the same way during the first cycle, mutual agreements were made to promote it as the appropriate way to organise lifestyle intervention in general practice. The fact that the health pro- fessionals perceived the developed lifestyle intervention as realistic in their daily practice and experienced ownership, reiterated that the action research had been conducted in a collaborative and equitable manner. Potential obstacles to social research, such as predominantly negative posture, as seen elsewhere in healthcare according to Albert et al. were not present [26]. 4.2. Implications for practice The suggested intervention may be integrated in the exist- ing structures of general practices in countries other than Denmark, provided that practice nurses are employed. It does not require acquisition of any equipment, as the health profes- sionals themselves were the main resources. The educational material used was extracted from existing material or self- made. The participating GPs were recruited based on their interest in diabetes, which we considered fundamental for their active involvement in the study. However, it is also a major limitation regarding the transferability to GPs with other main interests. It is common knowledge that GPs’ attitudes together with perceived external control factors (time and cost), influence the priority on management of behavioural risk factors [27]. By the end of the study period, the economic remuneration agree- ment between the Health Authorities and the General Practice Association changed and does not at present favour consulta- tion about lifestyle. This may limit the potential for targeting prediabetes in the general practice setting on a large scale, as only GPs with a previous vested and positive attitude to lifestyle modification may find a way to elicit remunerated for these consultations. For large scale studies in heterogeneous practices, a variety of intervention models adjusted to differ- ent contexts are recommended, or more radically a redesign Table 2 – Patient characteristics at inclusion, and differences in HbA1c and BMI from 0 to 3 month follow-up. Characteristics N Three months difference N P-value (From-to-) (95% CI) Sex, female (%) 39 (61) 64 Age, year, mean (SD) 58.3 (8.5) 64 HbA1c (%) mean (SD) 6.0 (0.3) 54 6.02–5.88 0.14 (0.06–0.21) 43 0.001 BMI (kg/m2 ) mean (SD) 32.1 (6.1) 62 31.90–31.31 0.59 (0.27–0.91) 46 0.001
  • 6. 28 primary care diabetes 8 ( 2 0 1 4 ) 23–29 of the health service models. Although the Danish primary health care system is less driven by commercial interests than in most other countries in the world. Further research is needed to develop effective and cost-effective individual- based real-world prevention strategies also beyond alternative needs assessments and settings, alongside consideration of population-based interventions to change behavioural norms, as recommend by the European guidelines [9,10]. 5. Conclusion An action research approach proved useful to involve gen- eral practitioners and practice nurses in the development and testing of a lifestyle intervention for people with prediabetes tailored for general practice. The developed intervention of six consultations during 1 year, in total 110 min showed signifi- cant short-term impact on HbA1c and BMI. The intervention is deemed feasible for a minority of engaged general practices with a particular interest for diabetes, but not necessarily for general population coverage. Authors’ contributions JAH, AHB and HTM carried out the study. Together they designed the study and conducted the interviews and work- shops. All authors were involved in the manuscript editing and the interpretation of results. AHB and HTM wrote the first drafts of the manuscript whilst HTM wrote the final paper, which was approved by AHB and JAH. Conflict of interest The Steno Health Promotion Centre is funded by Novo Nordisk A/S and the Novo Nordisk Foundation. The authors do not perceive this as a conflict of interests in this study. Acknowledgements Our appreciation goes to the participating GPs and practice nurses for their engagement in the action research process. We wish to thank GP Lars Dudal Madsen and GP Jens Damsgaard from the Regional Diabetes Committees for their endorse- ment. 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