Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000927820
Ethics application status
Approved
Date submitted
29/08/2012
Date registered
30/08/2012
Date last updated
10/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Creating childcare environments supportive of child obesity prevention: The effectiveness of an intensive population based dissemination intervention.
Scientific title
Are childcare services that receive an intense intervention (consisting of face-to-face, telephone & print support) more likely than childcare services that receive usual support to improve their policies and practices that are supportive of childhood obesity prevention.
Secondary ID [1] 281120 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity prevention 287291 0
Condition category
Condition code
Public Health 287619 287619 0 0
Health promotion/education
Diet and Nutrition 287620 287620 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will include the following evidence based components:

Executive support - Nominated Supervisors and management committees will be engaged and encouraged to communicate their endorsement of practice changes at meetings, through changes to position descriptions and reporting requirements.

Consensus processes - Meetings with service staff will be conducted to discuss and reach consensus regarding approaches for successfully achieving implementation of policies and practices

Training - A training workshop will be available to all services and will focus on the implementation of healthy eating policies and practices. Staff training will combine didactic and interactive components including opportunities for role play and facilitator provided feedback.

Tools and resources - Printed instructional materials, sample policies, planning templates, and self- assessment forms to allow self-monitoring of practice adoption.

Academic detailing - Service visits will be conducted to demonstrate skills learnt during training (i.e. observe and co-teach a Fundamental Movement Skills activity), and address identified deficits.

Recognition - Services providing a copy of their policy and documentation that demonstrates how practices are integrated into service routines will be acknowledged and promoted to other intervention services using communication strategies.

On-going support - Services will receive regular telephone support calls for 12 months to review progress, discuss deficits identified from self-monitoring; and facilitate problem solving.

Performance monitoring and feedback – Project records will be used to compile feedback reports regarding collective adoption progress of intervention services. Services will be encouraged to self-monitor progress towards implementation goals. Feedback will be provided during academic detailing visit and during telephone support calls.

Communication Strategy - small media strategies targeting intervention services only will be used to communicate key messages and case study successful implementation approaches.

Intervention strategies will be administered over a 12 month period.

The intervention aims to facilitate the following practice and policy changes:
- services having a written nutrition and physical activity policy
- service provision of water or reduced fat milk only to children
- service provision of a fundamental movement skills program
- service restriction of time engaged in small screen recreation
- service staff role modelling physical activity and healthy eating
- service staff monitoring lunchboxes and providing feedback to parents
- service staff provision of prompts and positive comments to children to encourage physical activity and healthy eating
Intervention code [1] 285580 0
Prevention
Intervention code [2] 285581 0
Behaviour
Comparator / control treatment
Usual support - consisting of standard staff development opportunities regarding child health and development which could include staff training or resources.
Control group
Active

Outcomes
Primary outcome [1] 287871 0
Primary Outcome: The change in prevalence of service policies and practices from baseline to immediately following the intervention (12 months later) as assessed via telephone interview with service staff. Where appropriate, survey items will be sourced from the U.S Nutrition and Physical Activity Self-Assessment for Child Care (NAPSACC) instrument and the Yale Rudd Centre Child Care Nutrition and Physical Activity Assessment Survey
Timepoint [1] 287871 0
Baseline and 12 month later
Secondary outcome [1] 298968 0
The change in prevalence of service policies and practices from baseline to immediately following the intervention (12 months later) as assessed via observation. Observations will occur in a randomly selected target sample of 40 childcare services. Where appropriate, observation items will be sourced from the U.S Nutrition and Physical Activity Self-Assessment for Child Care (NAPSACC) instrument and the Yale Rudd Centre Child Care Nutrition and Physical Activity Assessment Survey.
Timepoint [1] 298968 0
Baseline and 12 months later
Secondary outcome [2] 310419 0
The change in the physical activity and dietary intake behaviours of children while attending childcare 12 months following the commencement of the intervention as assessed via observation. Where appropriate, observation items will be sourced from the System for Observing Play and Leisure Activity in Youth (SOPLAY) and the Diet Observation at Child Care (DOCC).
Timepoint [2] 310419 0
12 months following the commencement of the intervention

Eligibility
Key inclusion criteria
All preschool and long day care services in the Hunter Region of NSW will be invited to participate.

AGE ** - The unit of intervention is the preschool or long day care service. (The intervention will focus on policies and practices for children aged 3-5 years)
Minimum age
3 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include childcare services that exclusively enrol children requiring specialist care, services that provide meals to children, and services that are part of government primary schools.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study information and consent forms will be mailed to services approximately 2 weeks before a telephone call from a research assistant requesting consent to participate in data collection. Randomisation will occur after baseline data collection and will by carried out centrally using a random number function in Mircosoft Excel.

The study information form will inform services that they will be randomly allocated to receive either the intervention or control. Services will not be actively told to which group they have been allocated, but due to the nature of the intervention, it will not be possible to blind services to their allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting services within the study region will randomly allocated in a 1:1 ratio to the intervention or control group using a random number function in Microsoft Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/09/2012
Actual
3/09/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5642 0
2259
Recruitment postcode(s) [2] 5643 0
2264
Recruitment postcode(s) [3] 5644 0
2265
Recruitment postcode(s) [4] 5645 0
2267
Recruitment postcode(s) [5] 5646 0
2278
Recruitment postcode(s) [6] 5647 0
2280
Recruitment postcode(s) [7] 5648 0
2281
Recruitment postcode(s) [8] 5649 0
2282
Recruitment postcode(s) [9] 5650 0
2283
Recruitment postcode(s) [10] 5651 0
2284
Recruitment postcode(s) [11] 5652 0
2285
Recruitment postcode(s) [12] 5653 0
2286
Recruitment postcode(s) [13] 5654 0
2287
Recruitment postcode(s) [14] 5655 0
2289
Recruitment postcode(s) [15] 5656 0
2290
Recruitment postcode(s) [16] 5657 0
2291
Recruitment postcode(s) [17] 5658 0
2292
Recruitment postcode(s) [18] 5659 0
2293
Recruitment postcode(s) [19] 5660 0
2295
Recruitment postcode(s) [20] 5661 0
2297
Recruitment postcode(s) [21] 5662 0
2298
Recruitment postcode(s) [22] 5663 0
2299
Recruitment postcode(s) [23] 5664 0
2300
Recruitment postcode(s) [24] 5665 0
2301
Recruitment postcode(s) [25] 5666 0
2303
Recruitment postcode(s) [26] 5667 0
2304
Recruitment postcode(s) [27] 5668 0
2305
Recruitment postcode(s) [28] 5669 0
2306
Recruitment postcode(s) [29] 5670 0
2307
Recruitment postcode(s) [30] 5671 0
2308
Recruitment postcode(s) [31] 5672 0
2312
Recruitment postcode(s) [32] 5673 0
2314
Recruitment postcode(s) [33] 5674 0
2315
Recruitment postcode(s) [34] 5675 0
2316
Recruitment postcode(s) [35] 5676 0
2317
Recruitment postcode(s) [36] 5677 0
2318
Recruitment postcode(s) [37] 5678 0
2319
Recruitment postcode(s) [38] 5679 0
2320
Recruitment postcode(s) [39] 5680 0
2321
Recruitment postcode(s) [40] 5681 0
2322
Recruitment postcode(s) [41] 5682 0
2323
Recruitment postcode(s) [42] 5683 0
2324
Recruitment postcode(s) [43] 5684 0
2325
Recruitment postcode(s) [44] 5685 0
2326
Recruitment postcode(s) [45] 5686 0
2327
Recruitment postcode(s) [46] 5687 0
2329
Recruitment postcode(s) [47] 5688 0
2330
Recruitment postcode(s) [48] 5689 0
2333
Recruitment postcode(s) [49] 5690 0
2334
Recruitment postcode(s) [50] 5691 0
2335
Recruitment postcode(s) [51] 5692 0
2336
Recruitment postcode(s) [52] 5693 0
2337
Recruitment postcode(s) [53] 5694 0
2338
Recruitment postcode(s) [54] 5695 0
2420
Recruitment postcode(s) [55] 5696 0
2421
Recruitment postcode(s) [56] 5697 0
2422
Recruitment postcode(s) [57] 5698 0
2423
Recruitment postcode(s) [58] 5699 0
2425
Recruitment postcode(s) [59] 5700 0
2427
Recruitment postcode(s) [60] 5701 0
2428
Recruitment postcode(s) [61] 5702 0
2429

Funding & Sponsors
Funding source category [1] 285901 0
Government body
Name [1] 285901 0
Australian National Preventive Health Agency
Country [1] 285901 0
Australia
Primary sponsor type
Individual
Name
Dr Luke Wolfenden
Address
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country
Australia
Secondary sponsor category [1] 284724 0
Government body
Name [1] 284724 0
Hunter New England Population Health
Address [1] 284724 0
Locked Bag 10
Wallsend NSW 2287
Country [1] 284724 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287929 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 287929 0
Locked Bag No. 1
New Lambton NSW 2305
Ethics committee country [1] 287929 0
Australia
Date submitted for ethics approval [1] 287929 0
Approval date [1] 287929 0
09/08/2012
Ethics approval number [1] 287929 0
12/08/15/5.01

Summary
Brief summary
Supporting childcare services to implement policies and practices which encourage children to eat healthily and be physically active has the capacity to make an important contribution in reducing the health burden of excessive weight gain in childhood. This study aims to assess the effectiveness of an intensive, population-based intervention in increasing the physical activity and healthy eating policies and practices of childcare services. The intervention will be the first of its kind internationally and will provide valuable information for health promotion policy makers and practitioners on ways to support services create environments more supportive of child obesity prevention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34639 0
Dr Luke Wolfenden
Address 34639 0
Hunter New England Population Health Locked Bag 10 Wallsend NSW 2287
Country 34639 0
Australia
Phone 34639 0
+61 2 4924 6567
Fax 34639 0
Email 34639 0
luke.wolfenden@hnehealth.nsw.gov.au
Contact person for public queries
Name 17886 0
Dr Dr Luke Wolfenden
Address 17886 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 17886 0
Australia
Phone 17886 0
+61 2 4924 6567
Fax 17886 0
+61 2 4924 6215
Email 17886 0
luke.wolfenden@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 8814 0
Dr Dr Luke Wolfenden
Address 8814 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 8814 0
Australia
Phone 8814 0
+61 2 4924 6567
Fax 8814 0
+61 2 4924 6215
Email 8814 0
luke.wolfenden@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

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Documents added automatically
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