Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr R.M.E. Jansink


Contact details

Afdeling Kwaliteit van Zorg-117
UMC St Radboud
P.O. Box 9101
6500 HB
+31 (0)24 3619641

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title



Study hypothesis

Adherence level to diabetes guidelines is moderate, especially on educational aspects. Changes in lifestyle is a major element of the patient treatment. Studies on motivational interviewing show promising results among dieticians. There are no primary care studies involving practices nurses.
Research questions:

1. What is the effect of structured diabetes care involving a practice nurse, that has been trained on motivational interviewing and equipped with practical tools on diet and exercise programmes compared to usual care on:
a. HbA1c
b. Diet and exercise
c. Other patient's clinical outcomes and professionals' adherence to process indicators based on the diabetes guidelines?

2. What is the incremental cost-effectiveness ratio of our implementation strategy compared to usual care?

Ethics approval

Not provided at time of registration

Study design

Randomized controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet


Diabetes mellitus type 2 (DM type II)


Diabetes care according to guidelines focussing on diet and exercise will be implemented using patient-oriented strategy embedded in a structured daily routine. The intervention practitioners have to decide on a schedule on how diabetes care is incorporated into the daily routine. The nurse trained in motivational interviewing (MI) has to activate the commencement of the patient to diet and exercise. The nurse will get a two-day course and follow-up meetings within a supervisory group twice during the first year. The two-day course will include an introduction on MI followed by group discussions and training in the technique using role-play on specific skills including: empowerment, ambivalence, decision balance schedule, stage of change and reflective listening. The practice nurse and patient have to come up with arrangements for the diet and exercise program by making use of MI. The patients will be equipped with a questionnaire and actometer for clinical parameters and short-term targets on diet and/or exercise. The patient should be educated on the interpretation of this information by the practice nurse.
The patients in the control group will receive usual care

Intervention type



Not Specified

Drug names

Primary outcome measures

Primary outcome measure will be HbA1c, but main process indicators will consist of changes in exercise as measured by validated actometer and questionnaires as well as diet, as measured by validated self-report forms before and after the intervention

Secondary outcome measures

Besides the actual paticipation in dieting and exercise programmes, we will determine the intentions of the patients according to the self efficacy (ASE) model. The quality of life of the patients will be measured by EQ-5D.We will also determine the degree of adherence to all other recommendations in the diabetes guidelines by process indicators and measurements of parameters such as, blood pressure and lipids. The focus on diet and exercise should not reduce adherence to other recommendations. In the process evaluation, the feasibility of the strategy will be discussed with all involved parties; and for the practice nurses we will have to explore how capable they were in administering MI.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

The trial will be held in general practices and all patients with type 2 diabetes, that are <80 years will be included. Patients with HbA1c levels above 8% and body mass index (BMI) above 25 kg/m^2 will also be included.

Participant type


Age group




Target number of participants


Participant exclusion criteria

Type 2 diabetes patients who are very ill and patients that are primarily managed in secondary care (e.g. by internist)

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Afdeling Kwaliteit van Zorg-117
6500 HB

Sponsor information


University Medical Center St Radboud, Center for Quality of Care Research (WOK) (The Netherlands)

Sponsor details

117 Kwazo
P.O. Box 9101
6500 HB

Sponsor type




Funder type

Research organisation

Funder name

ZonMw (The Netherlands Organization for Health Research and Development)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit



Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 protocol in
2. 2013 results in
3. 2013 results in

Publication citations

  1. Protocol

    Jansink R, Braspenning J, van der Weijden T, Niessen L, Elwyn G, Grol R, Nurse-led motivational interviewing to change the lifestyle of patients with type 2 diabetes (MILD-project): protocol for a cluster, randomized, controlled trial on implementing lifestyle recommendations., BMC Health Serv Res, 2009, 9, 19, doi: 10.1186/1472-6963-9-19.

  2. Results

    Jansink R, Braspenning J, Laurant M, Keizer E, Elwyn G, Weijden Tv, Grol R, Minimal improvement of nurses' motivational interviewing skills in routine diabetes care one year after training: a cluster randomized trial., BMC Fam Pract, 2013, 14, 44, doi: 10.1186/1471-2296-14-44.

  3. Results

    Jansink R, Braspenning J, Keizer E, van der Weijden T, Elwyn G, Grol R, No identifiable Hb1Ac or lifestyle change after a comprehensive diabetes programme including motivational interviewing: a cluster randomised trial., Scand J Prim Health Care, 2013, 31, 2, 119-127, doi: 10.3109/02813432.2013.797178.

Additional files

Editorial Notes