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Trial registered on ANZCTR
Registration number
ACTRN12624000998549
Ethics application status
Approved
Date submitted
2/08/2024
Date registered
16/08/2024
Date last updated
16/08/2024
Date data sharing statement initially provided
16/08/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effect of online delivery of the MS-Get-a-Head-Start programme on physical activity self-efficacy of people with multiple sclerosis: a randomised pilot trial.
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Scientific title
The effect of online delivery of the MS-Get-a-Head-Start programme on physical activity self-efficacy of people with multiple sclerosis: a randomised pilot trial.
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Secondary ID [1]
312628
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None
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Universal Trial Number (UTN)
U1111-1311-2025
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Trial acronym
MSGHS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis
334580
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Condition category
Condition code
Neurological
331178
331178
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0
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Multiple sclerosis
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Physical Medicine / Rehabilitation
331305
331305
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0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
1. Name:
The online MS Get a Head Start (MSGHS)
2. What:
This study specifically refers to the ONLINE Multiple Sclerosis (MS) Get a Head Start programme. The six-week interval-based exercise and education programme is delivered fully online via prerecorded videos. The programme commences with participants watching a 20-minute welcome video that introduces them to the programme and outlines what they should expect. It also covers educational information on proactive heat sensitivity management and setting up a safe exercise space. Each week the participants receive an email with two exercise videos and one education video to watch.
All participants receive an online PDF course handbook prior to starting and are also offered a physical copy of the programme posted to them. The handbook provides all the supporting education material for the intervention. This includes the education sections for each week as well as goal setting, activity diary recording, and weekly reflective work.
Participants are encouraged to have a sturdy chair and either an exercise mat or a towel /rug on which they can complete floor exercises. No further exercise equipment is needed.
3. Procedure for the Auckland University of Technology (AUT) “The effect of online delivery of the MS-Get-a-Head-Start programme on physical activity self-efficacy of people with multiple sclerosis: a randomised pilot trial”
a. Advertising flyer distributed
b. Potential participants directed to the website with the participant information form and short explanatory video
c. Interested participants email the researcher and can ask any further questions about the study via email or a scheduled a phone call. If still interested, the researcher then emails them a link to fill out a form gathering key screening information. If suitable, they are directed to complete the following screening questionnaires;
i. Physical Activity Readiness Questionnaire
ii. The patient-determined disease steps screening measure
d. If the participants meet the inclusion requirements they will be emailed a link to complete the consent form online.
e. Once the consent form is completed they will then be randomized into either the intervention group or the waitlist control group. The intervention group will be sent a link to register themselves to the online MSGHS programme, this will then start the automated programme. Both groups will be emailed a link which asks them to provide some basic demographic data (age, gender, ethnicity, and which region they live in) and will be asked to complete the outcome measures at week 0, week 7 and week 12.
f. Once the intervention group registers for the MSGHS programme they receive an automated welcome email containing the supporting PDF booklet, welcome video and the link to complete the outcome measures. They can download and save the workable PDF booklet on their own computer. We do not collect any data from the PDF workbook. They will be given the option to request a hard copy of the booklet to be sent to them if they prefer.
g. The intervention group then receives one email each week for 6 weeks. This email contains two exercise videos and one education video. It also details what the expected course work is for that week and asks the participants to reply to the email if they have experienced and injuries, issues or adverse events during the programme.
h. The exercise videos deliver interval training, which gradually increases over the 6 weeks. The rest period to exercise is a 1:1 ratio between each set. There are nine different exercises delivered in each video. Participants are encouraged to take at least a 1 minute rest after the third and sixth exercise, but can pause the video to extend this rest if needed.
i. The nine exercises are a combination of cardiovascular, strength and balance exercises. Participants are encouraged to work as hard as they can during each exercise. Encouraging a vigorous level of intensity as 8/10 on BORG rating of perceived exertion. An explanation on what “hard” can feel like safely is explained in the welcome video. Each exercise is demonstrated and then options of regressions and progressions are demonstrated to allow participants to find a level that is appropriate for them. The exercise videos last for approximately 35 – 45 minutes and safety introduction is provided at the start of each video. Participants are encouraged to leave at least one day between completing the first exercise video of the week and then the second.
j. For an example of exercises provided, exercises delivered in week 1 session 1; calf raises, sit to stand, speed box, 4 point kneeling leg extension, bridging, plank, standing feet together head turns, tandem stand, toe extension stretch. Exercises delivered in week 1 session 2; seated dorsiflexion, seated wrist extension, standing 1 leg alphabet, supine table top holds, side plank, side leg lifts, standing knee flexion, heel kicks in standing, prone quad stretch.
k. Each education video lasts approximately 30 – 40 minutes and the PDF handout of the power point presented is attached to each weekly email. The six topics discussed are fatigue management, exercise prescription, pain management, cognitive management and psychological wellbeing, other services, where to from here. The main education points are also delivered within the MSGHS PDF booklet.
l. Each week participants are also asked to complete course work weekly, include goal setting, exercise schedule and diary, reflections and key activities to support regularly physical activity.
m. All the participants have access to all the exercise and education videos provided at the end of the programme via their own login to the MSGHS website. They have access to these for 12 months.
4. Who is Providing:
Gilly Davy is the founder and clinical lead of the MSGHS programme and has provided all online recordings. She has a BSc Hons Physiotherapy and Post Grad Certificate in Health and Rehabilitation Science. With 20 years of experience as a clinical neurological physiotherapist, she has spent the last 15 years specialising in assessing and treating individuals with multiple sclerosis.
MSGHS is a company that also provides health professional education courses both online and in person www.ms-ghs.com
5. How:
The programme is delivered online via pre-recorded material that is provided in automated weekly emails. Each email contains two exercise videos and one education video. The email also includes the course work for each week and asks participants to respond if they have perceived any incidents or adverse effects during the programme.
6. Where:
As MSGHS online intervention is provided fully online via pre-recoded material and automated delivered, participants can choose where and when they want to complete the intervention each week.
7. When and How Much:
Participants complete a minimum of the two exercise videos each week, lasting approximately 35- 45 minutes. They also watch the education video lasting approximately 30 -40 minutes and then have approximately 30 minutes of course week to complete each week. The participants can choose to complete any part of the intervention at a time that suits them during the week.
8. Tailoring:
Each exercise is demonstrated and a regression and progression option are provided so individuals could choose on the day which level of the exercise they want to do. They are encouraged to complete the whole video in one go, but can pause and rest as many times as they need.
They are encouraged to complete the two exercise videos and reassured that they can repeat the video sessions more times through the week if they choose to. The course work which they are encouraged to complete in the PDF booklet also helps to make the programme tailored.
9. Modifications:
Each exercise is demonstrated and a regression and progression option are provided so individuals could choose on the day which level of the exercise they want to do.
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Intervention code [1]
329146
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Rehabilitation
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Intervention code [2]
329147
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Lifestyle
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Intervention code [3]
329148
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Behaviour
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Comparator / control treatment
Once the consent form is completed they will then be randomized into either the intervention group or the waitlist control group. The waitlist control group will be emailed a link which asks them to provide some basic demographic data (age, gender, ethnicity, and which region they live in) and will be asked to complete the outcome measures at week 0, week 7 and week 12. The control group are not asked to participate in any thing different to their normal day to day life.
After the outcome measures have been completed in week 12 the waitlist control group will be notified that they can access and complete the online MSGHS programme. The waitlist group will have the identical experience and access to the programme as the intervention group (but will not be asked to complete the outcome measures).
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Control group
Active
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Outcomes
Primary outcome [1]
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Physical activity self efficacy
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Assessment method [1]
338940
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Self-efficacy for exercise scale
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Timepoint [1]
338940
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Baseline, week 7 and week 12 post-baseline
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Primary outcome [2]
339066
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Self-management self-efficacy
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Assessment method [2]
339066
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Self-efficacy for managing chronic disease
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Timepoint [2]
339066
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Baseline, week 7 and week 12 post-baseline
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Primary outcome [3]
339067
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Self-efficacy of functional gait
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Assessment method [3]
339067
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The MS 12-point walking scale.
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Timepoint [3]
339067
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Baseline, week 7 and week 12 post-baseline
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Secondary outcome [1]
437965
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Self-reported physical activity level
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Assessment method [1]
437965
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The Godin Leisure-Time exercise questionnaire
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Timepoint [1]
437965
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Baseline, week 7 and week 12 post-baseline
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Secondary outcome [2]
437966
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software usability
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Assessment method [2]
437966
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Health Information Technology Usability Evaluation Scale
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Timepoint [2]
437966
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Week 12 post-baseline
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Secondary outcome [3]
438461
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Self-reported physical activity level
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Assessment method [3]
438461
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the incidental and planned exercise questionnaire.
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Timepoint [3]
438461
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Baseline, week 7 and week 12 post-baseline
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Eligibility
Key inclusion criteria
• Men and women nationwide between the ages of 18 and 70 years
• Have a diagnosis of MS
• If they have been assessed using the Expanded Disability Status Scale (EDSS) they need to have a score between 0 – 4 (which means participants would have mild disability and be able to walk unaided)
• Score “no” to all questions on the Physical Activity Readiness Questionnaire. If a “yes” was scored on the first question, they can seek medical approval from their GP. They will not be considered if they scored “yes” on any of the other questions.
• Score 3 or less on the Patient-Determined Disease Steps questionnaire
• Able to get on and off the ground independently.
• Have access to the internet
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants will be excluded from the study for the following reasons:
• If they state they are not able to follow a remote video lead exercise programme
• If they have had a relapse within the last 3 months
• If they are not able to access the internet on a twice-weekly basis to watch the education and exercise sessions
• If they have previously been treated clinically by Gilly Davy or already participated in the MSGHS programme
• If they have heart disease, high blood pressure, any respiratory condition (mild asthma excluded), any illness, infection or injury that prevents them from participating in an exercise programme.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator, randomly numbers from 1 –35 allocation via a odd/even number to intervention or control.
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
1/06/2024
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Date of last participant enrolment
Anticipated
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Actual
31/07/2024
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Date of last data collection
Anticipated
31/10/2024
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Actual
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Sample size
Target
35
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Accrual to date
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Final
35
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Recruitment outside Australia
Country [1]
26475
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New Zealand
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State/province [1]
26475
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Funding & Sponsors
Funding source category [1]
317063
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Charities/Societies/Foundations
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Name [1]
317063
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New Zealand Multiple Sclerosis Research Trust
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Address [1]
317063
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Country [1]
317063
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New Zealand
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Primary sponsor type
University
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Name
Auckland University of Technology
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Address
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Country
New Zealand
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Secondary sponsor category [1]
319330
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None
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Name [1]
319330
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none
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Address [1]
319330
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Country [1]
319330
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315812
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Auckland University of Technology Ethics Committee
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Ethics committee address [1]
315812
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https://www.aut.ac.nz/research/researchethics
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Ethics committee country [1]
315812
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New Zealand
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Date submitted for ethics approval [1]
315812
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24/01/2024
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Approval date [1]
315812
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28/05/2024
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Ethics approval number [1]
315812
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24/7
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Summary
Brief summary
This study aims to determine if delivering the online and fully automated exercise programme MS-Get-a-Head-Start (MSGHS) helps people living with multiple sclerosis (MS) increase their confidence in exercising and physical activity levels. The MSGHS programme is a 6-week exercise and education programme developed to provide exercise and integrate education and behaviour change strategies. The aim of this pilot study is to evaluate the feasibility and practicality of extending this to a full randomised controlled study to evaluate effectiveness of the MSGHS programme to improve self-efficacy and PA in PwMS.
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Trial website
https://www.ms-ghs.com/aut-research-project-msghs-patient-program/
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mrs Gillian Davy
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Address
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MS Get a Head Start, PO Box 79242, Royal Heights, Auckland 0656
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Country
135882
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New Zealand
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Phone
135882
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+64220440295
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Fax
135882
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Email
135882
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[email protected]
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Contact person for public queries
Name
135883
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Gillian Davy
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Address
135883
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MS Get a Head Start, PO Box 79242, Royal Heights, Auckland 0656
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Country
135883
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New Zealand
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Phone
135883
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+64220440295
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Fax
135883
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Email
135883
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[email protected]
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Contact person for scientific queries
Name
135884
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Gillian Davy
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Address
135884
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MS Get a Head Start, PO Box 79242, Royal Heights, Auckland 0656
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Country
135884
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New Zealand
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Phone
135884
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+64220440295
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Fax
135884
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Email
135884
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
No additional documents have been identified.
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