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p r i m a r y c a r e d i a b e t e s 8 ( 2 0 1 4 ) 23–29

Contents lists available at ScienceDirect

Primary Care Diabetes

j o u r n a l h o m e p a g e : h t t p : / / w w w . e l s e v i e r . c o m / l o c a t e / p c d

riginal research

ction research led to a feasible lifestylentervention in general practice for people withrediabetes

elle Terkildsen Maindala,∗, Ane Bondeb, Jens Aagaard-Hansenb

Section for Health Promotion and Health Services and Section of General Practice, Department of Public Health,arhus University, DenmarkSteno Health Promotion Centre, Steno Diabetes Centre, Gentofte, Denmark

r t i c l e i n f o

rticle history:

eceived 27 March 2013

eceived in revised form

November 2013

ccepted 28 November 2013

vailable online 19 December 2013

eywords:

ction research

easibility

eneral practice

ealth behaviour

ealth services research

ifestyle

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

rediabetes 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.

ry Ca

volunteers without comorbidities [2–7]. Furthermore, the

© 2013 Prima

. Introduction

ifestyle interventions are effective in delaying the onset ofype 2 diabetes (T2D) in large randomized trials, but theranslation from research to routine primary care remains a

∗ Corresponding author at: Section for Health Promotion and Health Serllé 2, 8000 Aarhus C, Denmark. Tel.: +45 87 16 79 29; fax: +45 86 12 47

E-mail addresses: htm@alm.au.dk (H.T. Maindal), AHBO@steno.dk (A751-9918/$ – see front matter © 2013 Primary Care Diabetes Europe. Puttp://dx.doi.org/10.1016/j.pcd.2013.11.007

re Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

challenge [1]. The effective interventions have been developedand tested in selected populations, often among motivated

vices, Department of Public Health, Aarhus University, Bartholins88.

. Bonde), JXAH@steno.dk (J. Aagaard-Hansen).

effective interventions were usually complex, conducted inoptimal conditions and with substantial resource alloca-tion. Less resource-intensive interventions, based on selected

blished by Elsevier Ltd. All rights reserved.

b e t e s 8 ( 2 0 1 4 ) 23–29

Fig. 1 – Action research design, timeline, workshops andinterviews used in the development of a prediabetes

24 p r i m a r y c a r e d i a

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 weredeveloped recommending concepts and structures for inter-vention programs as well as a new behavioural change modelwas developed as part of the IMAGE project summariz-ing behavioural strategies for successful sustained lifestylechange [8,9]. Further the National Institute for Health andClinical E developed guidelines for preventing type 2 diabetes[10]. The guidelines emphasised prevention at different levelsusing existing local interventions.

Despite guidelines findings are still inconsistent and mostoften rely on local actors such as community organisationslike the YMCA [11–15]. An optimised lifestyle programme forT2D or prediabetes was evaluated in “real-life” primary health-care centres in Holland [16], but the programme was no moreeffective than routine care. The involvement and participationof the mutually interdependent professionals, patients andcommunities seems to be crucial for successful implemen-tation of diabetes prevention strategies in “real life” primarycare [17,18].

The aim of this study was to develop and pilot a feasi-ble lifestyle intervention for people with prediabetes tailoredfor 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 termprediabetes is a common term for hyperglycaemic conditionincluding 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 intothe health care system, and this tax-funded health care sys-tem ensures free access for all citizens to general practiceservices. T2D is predominantly diagnosed and treated byGPs [19]. Clinical guidelines advocate that GPs should pre-vent diabetes and inform patients about healthy lifestyle,but no specific recommendation is provided [20]. Danish GPsoperate as independent contractors within the public healthservice and are remunerated based on a combination of fee-for-service (2/3) and capitation basis (1/3) [19]. Approximately60% of GPs employ practice nurses who provide a variety of ser-vices depending on their competencies and the organisationof the clinic.

2.2. Action research design

Action research was chosen to tailor the intervention andto ensure involvement of the general practice staff. Actionresearch is usually conducted in two cycles or phases, the firstbeing 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 secondtesting phase to evaluate the feasibility of what was modelledin the first phase [22]. Accordingly, we conducted two action

intervention.

research phases, the first for modelling and the second fortesting. Workshops were conducted with the health profes-sionals at four stages – in the beginning and the end of eachphase. In addition, each practice was visited and interviewedthree times during the study period – two with each during thefirst phase and one with each of the remaining six practicesduring 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 withthe general practice staff to develop and test the intervention.

2.4. Recruitment of GPs and staff

Purposeful selection of general practices for the study waschosen, as commitment to close collaboration between par-ticipants and researchers in the intervention developmentprocess was crucial [21]. A total of eight general practiceswere recruited in collaboration with the coordinators of thetwo largest regional diabetes committees in Denmark. All

had a special interest in diabetes which was a prerequisitefor engaging in the study. All the practices employed practicenurses, although this was not a criterion for participation. The

p r i m a r y c a r e d i a b e t e s

Table 1 – Recruitment of patients with prediabetes ineight general practices.

Practice Cycle 1 Cycle 2 Total

Practice A 4 8 12Practice Ba 5 0 5Practice Ca 5 0 5Practice D 7 3 10Practice E 5 3 8Practice F 4 2 6Practice G 5 4 9Practice H 4 5 9

poIrpa–

2

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2

Ptaaw

ini

ait

tions for the next phase were: what would be the number of

Total 39 25 64

a Practice dropped out in cycle 2 for administrative reasons.

articipants included eight GPs and ten practice nurses asne GP from a large clinic entered three nurses to the project.n the second phase, two GPs dropped out for administrativeeasons. Prior to the study, none of the included practices hadrocedures for prediabetes. Mid-way through the study, anttempt was made to recruit general practices without nurses

but without success.

.5. Recruitment of patients

Ps were asked to recruit 4–5 patients in each phase, withhom they were going to develop the intervention. The

nclusion criteria were: approximately 40–65 years of age, atigh risk of prediabetes (BMI > 30 kg/m2) and/or prediabetesiagnosed by any of the following: raised fasting glucose

BG > 6.0 mmol/l), glucose intolerance (by the standard diag-ostic criteria) or ‘glycosylated haemoglobin’ (HbA1c) 6.0–6.4%.o exclusion criteria, such as comorbidity were defined. ThePs chose different recruitment procedures. Two performed

his systematically by searching on the above criteria in theirwn patient databases. The remaining did it by recalling rele-ant patients seen within the last year. The identified patientseceived a letter or a phone call from the nurse with an invi-ation to a consultation about their diabetes risk and lifestyle.he recruitment procedures resulted in 39 patients from 8ractices in the first phase and 25 patients from 6 practices

n the second phase (Table 1). The two GPs that recruited sys-ematically found that less than 50% of the identified patientsccepted the invitation to attend.

.6. Data generation and analysis

atient data were collected by practice staff and handed overo the research team in an anonymous form. A descriptivenalysis of the patients’ characteristics and comparison of BMInd HbA1c measurements at 0 and 3 months by paired t-testsas carried out using the statistical work package Stata 11.0.

Practice data were collected by the researchers during thenterviews and workshops with the GPs and the practiceurses. The researchers took minutes from the workshops and

nterviews.A preliminary analysis was performed by the researchers

fter each series of interviews and after each workshop. Thenterviews were analysed searching for statements accordingo the specific topic for the workshops in the modeling and

8 ( 2 0 1 4 ) 23–29 25

testing phases. Data were assessed by the three researchers(JAH, AHB and HTM) and any differences in interpretation wereresolved by mutual agreement before the workshops. The find-ings were then presented to the health professionals in thenext workshop for further development. The intervention pre-sented, as a result of the study, was agreed upon in the finalworkshop.

2.7. Ethical and legal aspects

The study was conducted in full compliance with the HelsinkiDeclaration. All patient information from the practices washandled anonymously and there was no direct patient contact.Consequently, permission from the Regional Research EthicsCommittee was not required in accordance with Danish law[23]. It was neither necessary to obtain patient consent, norachieve permission from the Danish Data Protection Agencyto store the data. GPs sought and achieved authorisation toparticipate in the study from the Danish Medicines Agency, asSteno Diabetes Centre is a subsidiary of the pharmaceuticalcompany Novo Nordisk A/S.

3. Results

3.1. Results from the first phase

All practices chose to provide the lifestyle intervention as aseries of consultations with the practice nurse as the primaryhuman resource. The GPs role was in the initial and then finalconsultation in order to conclude with the patient and markthe 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 withwhen relevant. All the practice nurses used written mate-rial about lifestyle to support the consultations. This includedpublished booklets and pamphlets from the Danish Healthand Medication Authorities that are available for patients andpractitioners either free from the homepage or at very lowcost. Some of them also used self-made registration forms for24 h food and beverage intake and lists of local opportunitiesfor physical exercise. All practices emphasised an individ-ual approach tailored to the needs and the risk profile of thepatient.

In two cases, the interventions differed from a traditionalconsultation. One GP experimented using a walking fitnesstest as a tool with some patients. One practice nurse phonedthe patients to support their efforts. However, these activi-ties were time consuming and therefore left out in the secondphase.

The practices had provided from one to five consultationsand spent between 30 and 150 min per patient during the firstintervention period. The duration of the consultations varied,as did the intervals between them. Therefore, specific ques-

consultations in the final recommended lifestyle intervention,the themes for each one, the spacing between them and thetotal minutes to spend?

b e t e

26 p r i m a r y c a r e d i a

3.2. Results at the end of the second phase: thesuggested lifestyle intervention

By the end of the second phase, the researchers and the healthprofessionals agreed on a lifestyle intervention for the pre-vention of T2D in people with prediabetes in Danish generalpractices as outlined in Fig. 2.

The recommended intervention consists of five consulta-tions in a span of approximately 6 months and a final statusafter 1 year. The initial and final consultations will be under-taken by the GP as he/she has the technical and economicalmandate to initiate and terminate treatment and follow-upaccording to the medical condition. The core of the lifestyleintervention is undertaken by the practice nurse. Total timerequired, 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) goalsetting 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 consultationswith the practice nurse, with focus on either diet or exerciseor both, according to the patients’ motivation and risk profile.Goal setting will also be included in the core intervention. Theeducational approach will be supportive to the patient’s goalsand to define small achievable steps of behavioural changein commonly agreed action plans. The use of supportive edu-cational material would vary according to what the practicenurse 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 theDanish Health and Medical authorities. It is a self-help guidebased on the official recommendations and newest evidenceon the importance of diet and physical activity for weight reg-ulation and psychological aspects of behavioural change. Thebooklet does not contain specific references, but The Stages ofChange Theory by Prochaska and DiClimente and MotivationalInterviewing by Miller and Rollnick is part of the theoreticalfoundation.

3.3. Patient characteristics and 3 month changes inHbA1c and BMI

There were 64 participating patients with a mean age of 58years (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 HbA1canalysis and 46 patients (72%) for the BMI analysis. Follow upresults 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 GPsand practice nurses expressed that they had gained moreconfidence in the patient-centred approach during theaction research process. They found themselves asking more

s 8 ( 2 0 1 4 ) 23–29

open-ended questions and they tended to listen more, andgave less advice. The nurses explained that they were now ableto make a shift from an explaining and counselling role in thefirst consultations to a facilitating and supporting role in thefollowing. One GP said that she had never been as “quiet andlaid-back with such success”. The practitioners expressed howtaking lifestyle more seriously had given them the courage tobe more persistent. Previous to the project it had been easier to“give up”. They all found that the competencies obtained fromthis study in relation to prediabetes were equally relevant forother risk conditions and behavioural changes in general.

It arose as an issue several times during the study periodthat “one size does not fit all”. Six consultations may be suit-able for the “average” patient to change lifestyle, but somepatients require a longer and more intensive intervention.This was the case when social, mental or medical issues inaddition to prediabetes were present.

Another issue was the term prediabetes. Prior to this study,the general practice staff had not considered this term forhyperglycaemic conditions, but called it “grey zone” or “highrisk of diabetes”. Now they preferred “prediabetes”, as theyfound it useful in assisting them to get messages across tothe patients, and they found that for some patients, the diag-nosis of “prediabetes” was a cue to action, as diabetes was acondition they wanted to avoid.

4. Discussion

This study, employing action research, led to a feasible shortlifestyle intervention for people with prediabetes being devel-oped in general practices with practice nurses employed.The feasibility was gained through the active participationof practice staff in the development. The developed interven-tion comprised a standardised package of themes, educationalprinciples and a time frame of 6 months (110 min). The mainthemes to address were motivation, food, exercise and goalsetting with small steps. These themes should be coveredin a flexible and patient-centred way, choosing educationalmaterial and the choice of health behaviours focus accord-ing to individual needs. The first and the last consultationshould be delivered by the GP and the core four by the practicenurse. Only in one practice did the GP want to take all consul-tations. The intervention was developed and tested with 64patients and showed a positive short-term effect on HbA1cand BMI, which could be interpreted as proxies of progressionto type 2 diabetes. Despite the small amount of participantsdue 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 guidelinesas it target both diet and physical activity, mobilize social, localsupport, involve behaviour change techniques, and providefrequent contacts [8].

Other prevention studies targeted people with prediabetesunder “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 presentstudy focused especially on this issue as part of the “real-life”adaptation. Evans et al. [25] made an attempt similar to ours bytailoring a preventive intervention involving both the patients

p r i m a r y c a r e d i a b e t e s 8 ( 2 0 1 4 ) 23–29 27

n de

afvset

4

Fagwihoiagcwuaaitmifrr

Fig. 2 – The feasible prediabetes lifestyle interventio

nd the health professionals. In line with Evans, we found thatocusing on the patient’s own knowledge, education and moti-ation was a valuable approach. Thus, our study revealed aignificant need for a patient-driven approach, where knowl-dge and education should be delivered in order to enhancehe informed decision-making of the individual.

.1. Methodological issues

rom a methodological perspective, the action researchpproach proved very useful. The health professionals fromeneral practices were engaged in a genuine collaborationith the researchers in order to develop a locally adapted

ntervention. The present study illustrates the positivity ofow additional focus on the local context and involvementf local stakeholders in the developmental stage of a complex

ntervention can create comprehension about realistic issuesssociated with the intervention, according to the newestuidelines for developing effective interventions in primaryare from UK [22]. The initial research agenda and activitiesere initially prepared by the researchers, but as the studynfolded, the planning of activities was shared by researchersnd practitioners, and in this respect in line with the nature ofction research [18,21]. When it became apparent that the var-ous practices had more or less structured the intervention inhe same way during the first cycle, mutual agreements were

ade to promote it as the appropriate way to organise lifestyle

ntervention in general practice. The fact that the health pro-essionals perceived the developed lifestyle intervention asealistic in their daily practice and experienced ownership,eiterated that the action research had been conducted in

Table 2 – Patient characteristics at inclusion, and differences in

Characteristics N

(From

Sex, female (%) 39 (61) 64Age, year, mean (SD) 58.3 (8.5) 64HbA1c (%) mean (SD) 6.0 (0.3) 54 6.02–5.BMI (kg/m2) mean (SD) 32.1 (6.1) 62 31.90–3

veloped through action research in general practice.

a collaborative and equitable manner. Potential obstacles tosocial research, such as predominantly negative posture, asseen elsewhere in healthcare according to Albert et al. werenot present [26].

4.2. Implications for practice

The suggested intervention may be integrated in the exist-ing structures of general practices in countries other thanDenmark, provided that practice nurses are employed. It doesnot require acquisition of any equipment, as the health profes-sionals themselves were the main resources. The educationalmaterial used was extracted from existing material or self-made.

The participating GPs were recruited based on their interestin diabetes, which we considered fundamental for their activeinvolvement in the study. However, it is also a major limitationregarding the transferability to GPs with other main interests.It is common knowledge that GPs’ attitudes together withperceived external control factors (time and cost), influencethe priority on management of behavioural risk factors [27]. Bythe end of the study period, the economic remuneration agree-ment between the Health Authorities and the General PracticeAssociation changed and does not at present favour consulta-tion about lifestyle. This may limit the potential for targetingprediabetes 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 forthese consultations. For large scale studies in heterogeneouspractices, a variety of intervention models adjusted to differ-ent contexts are recommended, or more radically a redesign

HbA1c and BMI from 0 to 3 month follow-up.

Three months difference N P-value

-to-) � (95% CI)

88 0.14 (0.06–0.21) 43 0.0011.31 0.59 (0.27–0.91) 46 0.001

b e t e

r

28 p r i m a r y c a r e d i a

of the health service models. Although the Danish primaryhealth care system is less driven by commercial intereststhan in most other countries in the world. Further researchis needed to develop effective and cost-effective individual-based real-world prevention strategies also beyond alternativeneeds assessments and settings, alongside consideration ofpopulation-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 andtesting of a lifestyle intervention for people with prediabetestailored for general practice. The developed intervention of sixconsultations during 1 year, in total 110 min showed signifi-cant short-term impact on HbA1c and BMI. The interventionis deemed feasible for a minority of engaged general practiceswith a particular interest for diabetes, but not necessarily forgeneral population coverage.

Authors’ contributions

JAH, AHB and HTM carried out the study. Together theydesigned the study and conducted the interviews and work-shops. All authors were involved in the manuscript editingand the interpretation of results. AHB and HTM wrote the firstdrafts 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 NordiskA/S and the Novo Nordisk Foundation. The authors do notperceive this as a conflict of interests in this study.

Acknowledgements

Our appreciation goes to the participating GPs and practicenurses for their engagement in the action research process. Wewish to thank GP Lars Dudal Madsen and GP Jens Damsgaardfrom the Regional Diabetes Committees for their endorse-ment. We thank our colleagues at the Steno Diabetes Centreand Aarhus University, Department of Public Health for invalu-able comments in different phases of the study period.

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