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Trial registered on ANZCTR


Registration number
ACTRN12615000806561
Ethics application status
Approved
Date submitted
26/05/2015
Date registered
3/08/2015
Date last updated
13/05/2019
Date data sharing statement initially provided
13/05/2019
Date results information initially provided
13/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The pre-diabetes intervention package in (PIPI) primary care study: Can a practice nurse-led structured dietary approach prevent progression to diabetes?
Scientific title
Determining the effect of a structured practice nurse delivered dietary advice programme compared with usual delivery of dietary advice on weight and HbA1c in people with prediabetes: a pilot study
Secondary ID [1] 284826 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PIPI - Primary care
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prediabetes 292211 0
Condition category
Condition code
Metabolic and Endocrine 292545 292545 0 0
Diabetes
Diet and Nutrition 292546 292546 0 0
Obesity
Public Health 295639 295639 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nurse Training Programme
Practice nurses at the four intervention practices and community education nurses will undertake a 6-hour training course, which will include nutrition principles, dietary assessment, goal setting, the context within which nutrition advice is given and how to measure height, weight and waist circumference. The course will be both theoretical and practical. The dietary content of the course will be based on the 2004 Diabetes and Nutrition Study Group of the European Association for the Study of Diabetes (EASD) evidence based guidelines for nutritional approaches to the treatment and prevention of diabetes mellitus. Dietary assessment and interpretation in the primary care setting, internal and external factors affecting food choices, culture, behaviour change and effective communication of dietary information will be included in the course. The course will be delivered by study investigators (public health physican, research dietitian, and research nurse/teacher) with input from a local dietitian (DS). A training manual will provide reference material, as well as research protocols.
A 3-hour update course will be run at 6 months. This will be case study based, using a selection of cases seen by the intervention practice nurses to illustrate particular challenges encountered when providing study participant dietary consultations.
A local dietitian will be readily available by email and phone to answer any questions from the practice nurses or discuss specific cases. The dietitian will also arrange monthly practice case review meetings with the practice nurses.
Participant Dietary Advice Programme
Participants will be asked to complete a brief dietary assessment, Starting the Conversation, a validated eight-item simplified food frequency instrument designed for use in primary care and health-promotion settings. Starting The Conversation (STC) was minimally modified, with permision, for the New Zealand context. The practice nurse will review the responses to the Starting the Conversation (STC) dietary assessment and ask additional dietary prompt questions to gain a better understanding of the participant’s dietary habits. The nurse will also enquire about additional contextual information such as the household membership and budget, who purchases the household foods and specific dietary requirements or choices such as vegetarianism, and take anthropometric measures (height, weight and waist circumference). A weight goal with the aim of a 5% weight loss over 6 months will be determined. The responses to the STC diet assessment, and the additional dietary and lifestyle questions will be used to inform three dietary goals negotiated with the participant, and the provision of individualised dietary advice tailored to their situation. This baseline appointment will take 30-45 minutes (including the study consent process). Fifteen minute follow-up sessions will be arranged 3 weeks later, then at 3 months and 6 months.
Patient management system key messages
The three individually tailored dietary goals determined between the practice nurse and participant will be incorporated into the general practice patient management systems. These messages will facilitate opportunistic targeted advice and guidance by GPs, thus reinforcing information provided at practice nurse dietary consultations. The goals/messges will be reviewed and updated accordingly at follow up practice nurse appointments.
Intervention code [1] 289618 0
Lifestyle
Intervention code [2] 292388 0
Treatment: Other
Intervention code [3] 292389 0
Prevention
Comparator / control treatment
The control group will continue to receive prediabetes dietary advice as currently delivered ('standard care'). Standard care can include dietary advice given by practice nurses according to their current knowledge and supplemented by dietary advice pamphlets. A referral may be sent to a dietitian for specialised dietary advice.
Control group
Active

Outcomes
Primary outcome [1] 292412 0
Weight measured in light clothing using calibrated digital scales.
Timepoint [1] 292412 0
6 months
Primary outcome [2] 295634 0
Glycated haemoglobin (HbA1c) measured from a blood sample.
Timepoint [2] 295634 0
6 months
Secondary outcome [1] 308890 0
Waist circumference measured with no clothing using a Lufkin Executive thinline (2m) tape measure
Timepoint [1] 308890 0
6 months
Secondary outcome [2] 316049 0
Body Mass Index (BMI) calculated from weight (measured in light clothing using calibrated digital scales) and height (measured with no shoes using a calibrated stadiometer).
BMI = weight in kilograms divided by (height in metres squared).
Timepoint [2] 316049 0
6 months
Secondary outcome [3] 316050 0
Blood Pressure measured using a calibrated automated sphygmomanometer
Timepoint [3] 316050 0
6 months
Secondary outcome [4] 316054 0
Lipids (total cholesterol, HDL-cholesterol, triglycerides) measured from a blood sample.
Timepoint [4] 316054 0
6 months

Eligibility
Key inclusion criteria
* Prediabetes (defined as HbA1c in the following range 41-49mmol/mol, or fasting plasma glucose in the following range 6.1-6.9mmol/L) diagnosed during the last 9 months
* Aged less than 70 years
* Body Mass Index greater than 25 kg/m2
* Able to communicate in English
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Taking Metformin
* Pregnant
* Terminal illness
* Unwilling to try to implement dietary advice provided by practice nurses

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participating Practices
In the study region there are two similar size provincial towns. For pragmatic reasons, practices in one provincial town will be the intervention practices and those in the other town will be the control practices. Four practices in each town will be invited to participate in the study. Participating intervention practices will be similar to the control practices. All will have employed practice nurses, and will include practices with a high proportion of enrolled patients have a high New Zealand deprivation index score.

Existing Eligible Participants
At study start all patients with prediabetes registered at participating general practices will be identified by running a patient management system computer query to find all those diagnosed with prediabetes within the last 3 months. A study information sheet and invitation letter will be sent to those patients who meet the study eligibility criteria. Within 5-7 days of the study information sheet and invitation letter being sent, a study practice nurse will call the patient to a first study appointment for those who agree to participate.

New Eligible Participants
After study start, any people newly diagnosed with prediabetes who fulfil all the eligibility criteria at participating practices will be invited to participate in the study.
All participating patients registered at the four control practices will be control participants, and all participating patients registered at the four intervention practices will be intervention participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a non-randomised trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample Size
A standard deviation of 18kg for weight and a correlation between baseline and follow-up of 0.95 were obtained using data from the 2008/09 New Zealand Adult Nutrition Survey and 2005 data from the Otago Diabetes Register. To detect a difference of 4kg in weight at 6 months with 90% power using the 5% level of significance requires 84 people in each group allowing for a 20% drop out.

Statistical Analysis Plan
Mixed models, with a random effect for practice will be used to analyse the data. The model will include a term for treatment and the baseline measure. It may also include additional variables to adjust for imbalance in the baseline characteristics. Chained equations using an appropriate model will be used to impute the missing data. This will be followed by a sensitivity anlaysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6157 0
New Zealand
State/province [1] 6157 0
Hawke's Bay

Funding & Sponsors
Funding source category [1] 289436 0
Government body
Name [1] 289436 0
Ministry of Health
Address [1] 289436 0
No 1 The Terrace
PO Box 5013
Wellington 6011
Country [1] 289436 0
New Zealand
Primary sponsor type
Individual
Name
Dr Kirsten Coppell
Address
Edgar Diabetes and Obesity Research
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 290032 0
None
Name [1] 290032 0
Address [1] 290032 0
Country [1] 290032 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291195 0
Northern A Health & Disability Ethics Committees
Ethics committee address [1] 291195 0
Ministry of Health
c/-Medsafe, level 6 Deloitte House
10 Brandon St
PO Box 5013
Wellington 6011
Ethics committee country [1] 291195 0
New Zealand
Date submitted for ethics approval [1] 291195 0
24/07/2014
Approval date [1] 291195 0
31/07/2014
Ethics approval number [1] 291195 0
14/NTA/114

Summary
Brief summary
There is an urgent need to implement effective prediabetes management strategies to reduce the increasing health and economic costs of New Zealand’s growing diabetes epidemic. Good clinical trial evidence has demonstrated that lifestyle advice prevents progression from prediabetes to diabetes. Evidence showing how similar results can be achieved in ‘real world’ settings is limited. Our non-randomised study aims to compare the effect of a multilevel primary care based prediabetes lifestyle intervention with current practice on weight and HbA1c in patients with prediabetes at 6 months, and to undertake a process evaluation. A collaborative prediabetes management package including practice nurse education and patient management system messages will be implemented in four general practices in a provincial town. Outcome measures will be compared with four ‘usual care’ (control) practices in another provincial town.
Trial website
Trial related presentations / publications
1. Coppell KJ, Freer T, Sharp K, Norton J, Spedding T, Engelbrecht R, Stride D, Gurdit-Singh, Hill J, Abel S, Ward L, Gray A, Whitehead L. Baseline characteristics of a high risk prediabetes population in New Zealand – the prediabetes intervention package in (PIPI) primary care study. Accepted Oral presentation, NZ Society of the Study of Diabetes Annual Scientific Meeting, Rotorua (May 2016). p45
2. Abel S, Whitehead L, Coppell KJ. Process Evaluation of the prediabetes intervention n primary care (PIPI) study. Accepted Oral presentation, NZ Society of the Study of Diabetes Annual Scientific Meeting, Rotorua (May 2016). p46
3. Abel S, Whitehead L, Coppell KJ. Factors influencing dietary improvement behavior amongst patients with prediabetes. Accepted Oral presentation, NZ Society of the Study of Diabetes Annual Scientific Meeting, Rotorua (May 2016). p81
4. Whitehead L, Crowe M, Coppell, K. Developing and evaluating complex interventions: enhancing the role of qualitative research. Accepted Oral presentation, 15th Annual Qualitative Methods (QM) Conference, Glasgow (May 2016)
5. Coppell KJ, Freer T, Sharp K, Norton J, Spedding T, Engelbrecht R, Stride D, Gurdit-Singh, Hill J, Abel S, Ward L, Gray A, Whitehead L. Characteristics of a high risk prediabetes population in New Zealand – the prediabetes intervention package in primary care study. Poster presentation, 14th Symposium of the International Diabetes Epidemiology Group, Vancouver (December 2015).
Public notes

Contacts
Principal investigator
Name 49298 0
Dr Kirsten Coppell
Address 49298 0
Edgar Diabetes and Obesity Research
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 49298 0
New Zealand
Phone 49298 0
+64 3 470 9074
Fax 49298 0
Email 49298 0
kirsten.coppell@otago.ac.nz
Contact person for public queries
Name 49299 0
Mrs Trish Freer
Address 49299 0
Health Hawke's Bay Ltd
PO Box 11141
Hastings 4158

Country 49299 0
New Zealand
Phone 49299 0
+64 6 871 5655
Fax 49299 0
Email 49299 0
Trish@healthhb.co.nz
Contact person for scientific queries
Name 49300 0
Dr Kirsten Coppell
Address 49300 0
Edgar Diabetes and Obesity Research
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 49300 0
New Zealand
Phone 49300 0
+64 3 470 9074
Fax 49300 0
Email 49300 0
kirsten.coppell@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary