ANZCTR - Registration

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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]

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

Excess weight

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Diet and Nutrition

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]

Lifestyle

Intervention code [2]

Treatment: Other

Intervention code [3]

Prevention

Comparator / control treatment

There will be no control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in glycated haemoglobin (HbA1c) (mmol/mol)

Timepoint [1]

6 months and 24 months after the intervention commences

Primary outcome [2]

Change in weight (kilograms)

Timepoint [2]

6 months and 24 months after the intervention commences

Secondary outcome [1]

Change in body mass index (BMI) calculated as weight (kilograms) divided by height (metres) squared

Timepoint [1]

6 months, 12 months, 18 months and 24 months after the intervention commences

Secondary outcome [2]

Change in waist circumference (centimetres)

Timepoint [2]

6 months, 12 months, 18 months and 24 months after the intervention commences

Secondary outcome [3]

Change in systolic blood pressure (mmHg)

Timepoint [3]

6 months, 12 months, 18 months and 24 months after the intervention commences

Secondary outcome [4]

Change in diastolic blood pressure (mmHg)

Timepoint [4]

6 months, 12 months, 18 months and 24 months after the intervention commences

Secondary outcome [5]

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]