Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12616000628448 |
Date of registration:
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16/05/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Mini Movers: A study evaluating the efficacy of a program to reduce sedentary behaviour in 2- to 4-year-old children.
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Scientific title:
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A pilot randomised controlled trial (RCT) examining the efficacy of a parent-focused information program to reduce sedentary behaviour in 2- to 4-year-old children. |
Date of first enrolment:
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14/07/2016 |
Target sample size:
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100 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12616000628448.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Ms Katherine Downing
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Address:
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Institute for Physical Activity and Nutrition (IPAN)
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway, Burwood VIC 3125
Australia |
Telephone:
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+61392446088 |
Email:
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k.downing@deakin.edu.au |
Affiliation:
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Name:
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Ms Katherine Downing
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Address:
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Institute for Physical Activity and Nutrition (IPAN)
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway, Burwood VIC 3125
Australia |
Telephone:
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+61392446088 |
Email:
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k.downing@deakin.edu.au |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Parents will be eligible to be included in the study if their child is between 2 to 4 years and they can speak, read and write fluent English.
Exclusion criteria: None
Age minimum:
2 Years
Age maximum:
4 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Public Health - Epidemiology
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Sedentary behaviour; Sedentary behaviour
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Intervention(s)
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Participants in the intervention group will participate in one group session (approximately 30 minutes), where they will be provided with information about sedentary behaviour, screen time and active play for their child. The session will be delivered by the PhD Candidate/Project Manager during the participants' playgroup time (at the usual playgroup setting). At this session they will receive, and be talked through, a booklet with information about the behaviours, guidelines for sedentary behaviour and physical activity in early childhood, ideas for active play and limiting screen time, and information about goal setting. They will then be asked to set two SMART (Specific, Measurable, Attainable, Relevant, Time-bound) goals relating to the outcomes of the study: one for increasing active play and one for limiting screen time. Parents will also receive 2-3 tailored text messages per week (for 6 weeks), which will include tips for limiting sedentary behaviour, ideas for active play, and prompts to check their progress with their goals.
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Primary Outcome(s)
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Change in screen time (minutes per day) measured by parent-report (reliability previously established)[Pre-intervention (baseline) and post-intervention (6 weeks post intervention commencement)]
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Change in sedentary time (minutes per day) measured objectively with activPAL accelerometers (valid and reliable in this population). activPALs will be worn for 7 consecutive days at both timepoints. [Pre-intervention (baseline) and post-intervention (6 weeks post intervention commencement)]
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Secondary Outcome(s)
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Feasibility: dose delivered - measured by attendance at the group session and with purposed-designed parent survey questions (e.g., "How many of the text messages did you read/click through to the links?")
[Post-intervention (i.e. 6 weeks post intervention commencement)]
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Feasibility: recruitment and retention - recruitment numbers will be recorded and retention calculated by the number of participants still enrolled in the program post-intervention
[Post-intervention (i.e. 6 weeks post intervention commencement)]
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Feasibility: engagement in the intervention - measured by parent responses to goal-checking text messages and qualitative telephone interviews (asking questions usefulness/relevance of the session and text messages)[Post-intervention (i.e. 6 weeks post intervention commencement)]
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Source(s) of Monetary Support
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NHMRC Postgraduate Scholarship
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Ethics review
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Status: Approved
Approval date:
Contact:
Deakin University Human Research Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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