Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000718246
Ethics application status
Approved
Date submitted
13/08/2009
Date registered
21/08/2009
Date last updated
6/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Reminder on Eating, Relaxation and Exercise Support for Health
Scientific title
Randomised Control Trial in playgroup mothers with young children-Lifestyle program to improve nutrition and physical activity behaviours, and perceived social support, physical health and mental health.
Universal Trial Number (UTN)
Trial acronym
REFRESH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of overweight and obesity, 237189 0
Preventino of chronic diseases including cardiovascular diseases, Type 2 diabetes and some cancers. 243557 0
Condition category
Condition code
Public Health 237375 237375 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention will include:
1. Trained Nutrition Educators will conduct six group based face to face education sessions of 20 minutes each on nutrition, physical activity, goal setting, self-monitoring and relapse prevention
2. Fortnightly emails
3. Mobile phone messages
4. Booklet will focus on healthy eating, physical activity (walking and integrated exercises at home), relaxataion, goal setting, self-monitoring and relapse prevention techniques.
Intervention code [1] 236775 0
Prevention
Intervention code [2] 236892 0
Lifestyle
Intervention code [3] 237118 0
Behaviour
Comparator / control treatment
Control group will be recruited at the same time as the interevention group. The control group will not be provided any interevention and will only participate in providing information via questionnaires at baseline, 6 months and 12 months
Control group
Active

Outcomes
Primary outcome [1] 238180 0
-To reduce the fat and sugar intake in the intervention group participants compared to the control group participants by 10%
-Data will be collected using self-reported questionnaires
-Data will be analysed using SPSS
Timepoint [1] 238180 0
Baseline, 6 months, 12 months
Primary outcome [2] 240637 0
-To increase the fibre, fruit and vegetable intake in the intervention group participants compared to the control group participants by 20%
-Data will be collected using self-reported questionnaires
-Data will be analysed using SPSS
Timepoint [2] 240637 0
Baseline, 6 months, 12 months
Primary outcome [3] 240638 0
To improve the dietary self-efficacy in the intervention group participants compared to the control group participants by 20%
-Data will be collected using self-reported questionnaires
-Data will be analysed using SPSS
Timepoint [3] 240638 0
Baseline, 6 months, 12 months
Primary outcome [4] 240639 0
-To increase the minutes of moderate intensity physical activity in the intervention group participants compared to the control group participants by 20%
-Data will be collected using self-reported questionnaires
-Data will be analysed using SPSS
Timepoint [4] 240639 0
Baseline, 6 months, 12 months
Primary outcome [5] 240640 0
-To improve the physical activity self-efficacy in the intervention group participants compared to the control group participants by 20%
-Data will be collected using self-reported questionnaires
-Data will be analysed using SPSS
Timepoint [5] 240640 0
Baseline
6 months
12 months
Primary outcome [6] 240641 0
-To improve the perception of social support in the intervention group participants compared to the control group participants by 20%
-Data will be collected using self-reported questionnaires
-Data will be analysed using SPSS
Timepoint [6] 240641 0
Baseline, 6 months, 12 months
Primary outcome [7] 240642 0
-To improve the overall perception of physical health and mental health in the intervention group participants compared to the control group participants by 10%
-Data will be collected using self-reported questionnaires
-Data will be analysed using SPSS
Timepoint [7] 240642 0
Baseline, 6 months, 12 months
Secondary outcome [1] 242481 0
Nil
Timepoint [1] 242481 0
Nil

Eligibility
Key inclusion criteria
Mothers with a child registered with Playgroup WA.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Mothers below the age of 18.
Mothers with a medical condition that may contraindicate their participation in the study.

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)
A list of playgroups registered with Playgroup WA in the Perth Metropolitan area will be obtained. Playgroups will then be categorised into low, medium and high socioeconomic status, according to their location and based on the socio-economic index for areas scores. Playgroups will be randomly selected to participate in the study using a random sampling method. Playgroups will then be randomly allocated to ether the control or intervention group using central randomisation by computer. In total, 450 mothers from playgroups will be selected to the intervention group and 450 mothers from playgroups will comprise the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers were generated in Excel software and listed against the playgroups.
Masking / blinding
Open (masking not 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
620
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237293 0
Government body
Name [1] 237293 0
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
Country [1] 237293 0
Australia
Primary sponsor type
Government body
Name
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL
Address
GPO BOX 1421
CANBERRA
ACT 2601
Country
Australia
Secondary sponsor category [1] 236775 0
University
Name [1] 236775 0
Curtin University
Address [1] 236775 0
Rm 470, Bldg 400
Kent Street
Bentley
WA 6102
Country [1] 236775 0
Australia
Other collaborator category [1] 751 0
Other Collaborative groups
Name [1] 751 0
Playgroup WA
Address [1] 751 0
PO Box 61
North Perth
WA 6906
Country [1] 751 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239392 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 239392 0
Ethics committee country [1] 239392 0
Australia
Date submitted for ethics approval [1] 239392 0
Approval date [1] 239392 0
09/12/2008
Ethics approval number [1] 239392 0
HR 183/2008

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29765 0
Address 29765 0
Country 29765 0
Phone 29765 0
Fax 29765 0
Email 29765 0
Contact person for public queries
Name 13012 0
Professor Peter Howat
Address 13012 0
Centre for Behavioural Research in Cancer Control, Curtin University of Technology, GPO BOX U1987, Perth, WA 6845
Country 13012 0
Australia
Phone 13012 0
+618 9266 1719
Fax 13012 0
Email 13012 0
[email protected]
Contact person for scientific queries
Name 3940 0
Professor Peter Howat
Address 3940 0
Centre for Behavioural Research in Cancer Control, Curtin University of Technology, GPO BOX U1987, Perth, WA 6845
Country 3940 0
Australia
Phone 3940 0
+618 9266 1719
Fax 3940 0
Email 3940 0
[email protected]

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

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

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIDietary outcomes of a community based intervention for mothers of young children: a randomised controlled trial2014https://doi.org/10.1186/s12966-014-0120-1
N.B. These documents automatically identified may not have been verified by the study sponsor.