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Trial registered on ANZCTR


Registration number
ACTRN12617000591358
Ethics application status
Approved
Date submitted
5/04/2017
Date registered
27/04/2017
Date last updated
13/05/2019
Date data sharing statement initially provided
13/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
What factors predict moving from prediabetes back to normal blood glucose following participation in a primary care nurse led prediabetes intervention package (PIP)?
Scientific title
Prediabetes Intervention Package (PIP) in Primary Care Study - What predicts regression from prediabetes to normal glucose regulation?


Secondary ID [1] 290488 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Prediabetes Intervention Package (PIP) in Primary Care Study
Linked study record
Trial Id: ACTRN12615000806561

Health condition
Health condition(s) or problem(s) studied:
Prediabetes 300872 0
Excess weight 301216 0
Condition category
Condition code
Metabolic and Endocrine 300972 300972 0 0
Diabetes
Diet and Nutrition 300973 300973 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention will be delivered by trained primary care nurses in the general practice setting. The purpose of the intervention is to deliver consistent evidence-based dietary messages to the patient by the primary health care team. The focus of the intervention is to provide patients (and their family/whanau) with an understanding of the principles of healthy eating, so they are empowered and able to make good dietary choices. That is, the dietary advice will not be prescriptive. The pragmatic intervention package, designed and trialled in collaboration with primary care providers has six components:
1. Health Professional Training and Support
Primary care nurses will undertake an intensive half-day training course on the nutritional management of prediabetes. The course is 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 evidence-based guidelines for nutritional approaches to the treatment and prevention of diabetes mellitus. (These guidelines were successfully translated into clinical trial setting in the LOADD study.) Dietary assessments in the primary care setting using a New Zealand modified version of Starting the Conversation:Diet, 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 with input from an experienced local dietitian, and experienced primary care nurse. A training manual will provide reference material, as well as research protocols. A 2-hour update course will be run at 6-months.
A locally-based dietitian will be available by email and phone to answer any queries or discuss specific clinical cases. The dietitian will also arrange monthly clinical case review meetings for 6 months at each practice. Both the primary care nurses and dietitian found that dietitian support and guidance was only required for up to 6 months. A research nurse will visit participating practices monthly to review intervention delivery processes and to provide support and advice, as needed, in order to maximise intervention fidelity. Fidelity will be reviewed at monthly practice visits, and components of the intervention delivered and resources provided for each participant at each intervention visit will be recorded as part of the integrated clinical data collection system.
All participating primary care nurses will be instructed on standard practices for measuring anthropometry and blood pressure. Practice equipment will be calibrated.
2. Individual Patient Education
All eligible participants will be offered an initial 30 minute individual dietary session with the primary care nurse. They will be asked to complete a brief dietary assessment (Starting the Conversation:Diet modified to the New Zealand context.) on arrival at the practice, prior to their appointment. They will be encouraged to bring family/whanau to the session. Two to three goals will be determined and they will be given individualised dietary advice tailored to their situation based on a set of structured questions and the brief dietary assessment. They will be provided with standard Be Active Everyday advice, that is, 30 minutes of physical activity of moderate intensity on most, if not all, days of the week. Fifteen minute follow-up sessions will be arranged at 1-2 weeks, 5-6 weeks, 3 months, 4 months with a 30 minute review at 6 months. Ongoing follow-up will be provided at 3-monthly intervals for a ‘weigh-in’ and to provide brief targeted dietary advice and support.
3. Goal Setting & Key Messages
Two to three individually tailored dietary goals determined between the primary care nurse and patient (based on the structured questions and brief dietary assessment) will be incorporated into the general practice patient management systems (PMS). These messages will facilitate opportunistic targeted advice and guidance by GPs, thus reinforcing information provided at primary care nurse dietary consultations. The goals/messages will be reviewed and updated accordingly at primary care nurse appointments.
4. Nutritionally supportive primary care environment
The dietary information provided in pamphlets, magazines and posters in participating general practice waiting rooms will be reviewed, and updated so that consistent appropriate dietary messages are reinforced within the primary care environment.
5. Community-based group education
Community group education sessions will be offered and attendance at all six sessions will be encouraged. The purpose of these community group education sessions will be to provide generic nutrition knowledge and advice, (for example, food label reading), problem solving skills and peer group support. The sessions will be delivered by trained lay people. Each group session will last 1-1.5 hours. Referrals to the community group education sessions will be made at the 1-2 week intervention appointment.
6. Written Resources
The main written patient resource used will the Diabetes New Zealand “Diabetes and healthy food choices” pamphlet.


Intervention code [1] 296564 0
Lifestyle
Intervention code [2] 297856 0
Treatment: Other
Intervention code [3] 297857 0
Prevention
Comparator / control treatment
There will be no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300399 0
Change in glycated haemoglobin (HbA1c) (mmol/mol)
Timepoint [1] 300399 0
6 months and 24 months after the intervention commences
Primary outcome [2] 300400 0
Change in weight (kilograms)
Timepoint [2] 300400 0
6 months and 24 months after the intervention commences
Secondary outcome [1] 329886 0
Change in body mass index (BMI) calculated as weight (kilograms) divided by height (metres) squared
Timepoint [1] 329886 0
6 months, 12 months, 18 months and 24 months after the intervention commences
Secondary outcome [2] 329887 0
Change in waist circumference (centimetres)
Timepoint [2] 329887 0
6 months, 12 months, 18 months and 24 months after the intervention commences
Secondary outcome [3] 332792 0
Change in systolic blood pressure (mmHg)
Timepoint [3] 332792 0
6 months, 12 months, 18 months and 24 months after the intervention commences
Secondary outcome [4] 332793 0
Change in diastolic blood pressure (mmHg)
Timepoint [4] 332793 0
6 months, 12 months, 18 months and 24 months after the intervention commences
Secondary outcome [5] 332893 0
Social Support Score for Diet and Exercise using questionnaire developed by Sallis et al (Sallis, J.F., Grossman, R.M., Pinski, R.B., Patterson, T.L., and Nader, P.R. (1987). The development of scales to measure social support for diet and exercise behaviors. Preventive Medicine, 16, 825-836.)
Timepoint [5] 332893 0
6 months and 24 months after intervention commences
Secondary outcome [6] 332895 0
Stages and proceses of weight mangement change using questionnaire devloped by Ana Andrés.
(Andrés, A., Saldaña, C., Beeken, R. (2015). Assessment of processes of change for weight management in a UK sample. Obesity Facts, 8, 43-53.)
Timepoint [6] 332895 0
6 months and 24 months after intervention commences
Secondary outcome [7] 332896 0
Sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
(Buysse,D.J., Reynolds,C.F., Monk,T.H., Berman,S.R., & Kupfer,D.J. (1989). The Pittsburgh Sleep Quality Index (PSQI): A new instrument for psychiatric research and practice. Psychiatry Research, 28(2), 193-213)
Timepoint [7] 332896 0
6 months and 24 months after intervention commences
Secondary outcome [8] 332897 0
Physical activity using the International Physical Activity Questionnaire (IPAQ) - www.ipaq.ki.se
Timepoint [8] 332897 0
6 months and 24 months after intervention commences
Secondary outcome [9] 332898 0
Quality of Life using the EQ-5D-5L questionnaire - www.euroqol.org
Timepoint [9] 332898 0
6 months and 24 months after intervention commences
Secondary outcome [10] 332900 0
Fasting insulin
Timepoint [10] 332900 0
6 months and 24 months after intervention commences
Secondary outcome [11] 332901 0
Fasting plasma glucose
Timepoint [11] 332901 0
6 months and 24 months after intervention commences

Eligibility
Key inclusion criteria
* Prediabetes defined as HbA1c more than 40 mmol/mol, but less than 50 mmol/mol
* Confirmation HbA1c is more than 40 mmol/mol, but less than 50 mmol/mol within 1 month prior to study entry
* Aged less than 70 years, but at least 18 years
* BMI greater than 25kg/m2
* Able to communicate in English
Minimum age
18 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Taking Metformin at the time of study enrolment
* Pregnant at the time of study enrolment
* Not willing to participate
* Planning to move from the area during the first 6 months of the study
* Terminal illness

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Mixed-method quasi-experimental study with pre- and post-intervention measures and a qualitative study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) and TRIPOD (Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis) reporting standards will be used. Poisson regression with robust standard errors and clustered by practice (using Huber-White estimators) will be used to identify predictors of regression to normoglycaemia at 6 months. Similar models will be used to examine risk factors for developing T2DM at 2 years. Exploratory modelling will use Markov models to identify variable associated with transitions between prediabetes, normoglycaemia and T2DM. Two-sided p<0.05 will be considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2017
Actual
31/07/2017
Date of last participant enrolment
Anticipated
30/06/2019
Actual
Date of last data collection
Anticipated
31/07/2021
Actual
Sample size
Target
400
Accrual to date
321
Final
Recruitment outside Australia
Country [1] 8478 0
New Zealand
State/province [1] 8478 0
Hawke's Bay

Funding & Sponsors
Funding source category [1] 295165 0
Government body
Name [1] 295165 0
Health Research Council of New Zealand
Country [1] 295165 0
New Zealand
Primary sponsor type
University
Name
University of Otago
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] 294846 0
Other
Name [1] 294846 0
Health Hawke's Bay Limited
Address [1] 294846 0
PO Box 11141
Hastings 4158
Country [1] 294846 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296882 0
Northern A Health and Disability Ethics Committees
Ethics committee address [1] 296882 0
Ethics committee country [1] 296882 0
New Zealand
Date submitted for ethics approval [1] 296882 0
08/02/2017
Approval date [1] 296882 0
03/03/2017
Ethics approval number [1] 296882 0
17/NTA/24

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1622 1622 0 0
/AnzctrAttachments/371801-PIP - Protocol Final. pdf.pdf

Contacts
Principal investigator
Name 70262 0
Dr Kirsten Coppell
Address 70262 0
Edgar Diabetes and Obesity Research
Dunedin School of Medicine
University of Otago
PO BOX 56
Dunedin 9054
Country 70262 0
New Zealand
Phone 70262 0
+64 3 470 9074
Fax 70262 0
Email 70262 0
[email protected]
Contact person for public queries
Name 70263 0
Trish Freer
Address 70263 0
Health Hawke's Bay
PO Box 11141
Hastings 4158
Country 70263 0
New Zealand
Phone 70263 0
+64 6 871 5655
Fax 70263 0
Email 70263 0
[email protected]
Contact person for scientific queries
Name 70264 0
Kirsten Coppell
Address 70264 0
Edgar Diabetes and Obesity Research
Dunedin School of Medicine
University of Otago
PO BOX 56
Dunedin 9054
Country 70264 0
New Zealand
Phone 70264 0
+64 3 470 9074
Fax 70264 0
Email 70264 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The specifics of what data will be available to be shared has yet to be discussed with all investigators. This will webpage will be updated accordingly in due course.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseWhat predicts regression from pre-diabetes to normal glucose regulation following a primary care nurse-delivered dietary intervention? A study protocol for a prospective cohort study.2019https://dx.doi.org/10.1136/bmjopen-2019-033358
EmbaseProximal and distal influences on dietary change among a diverse group with prediabetes participating in a pragmatic, primary care nurse-led intervention: a qualitative study.2021https://dx.doi.org/10.1017/S1368980021001968
EmbaseA diagnosis of prediabetes when combined with lifestyle advice and support is considered helpful rather than a negative label by a demographically diverse group: A qualitative study.2022https://dx.doi.org/10.1016/j.pcd.2021.10.003
N.B. These documents automatically identified may not have been verified by the study sponsor.