Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000110381
Ethics application status
Approved
Date submitted
22/02/2008
Date registered
27/02/2008
Date last updated
14/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A community based low intensity lifestyle intervention to prevent weight gain in women with children
Scientific title
In community based women with young children a low intensity behavioral lifestyle intervention prevents weight gain compared to standard education
Secondary ID [1] 281031 0
Nil
Universal Trial Number (UTN)
Trial acronym
HeLP-her
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of obesity 2864 0
Condition category
Condition code
Public Health 2998 2998 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group based self management behavioral lifestyle intervention. A total of four group sessions, 3 consecutive weekly 1 hour group sessions plus a review session at 4 months that focus on goal setting, self monitoring, problem solving skills and action plans. Diet advice included simple evidence based diet messages to reduce energy density. Physical activity advice was simple physical activity messages focusing on walking. Participants were provided with a pedometer and encouraged to walk in groups. On-going support is provided by monthly phone, email or mail contact based on the behavior, physical actvity and diet content of the group sessions over 12 months.
Intervention code [1] 2594 0
Lifestyle
Intervention code [2] 285492 0
Lifestyle
Comparator / control treatment
Single group 40 min education session based on population guidelines. The group was provided with a pedometer but no ideal step count or support.
Control group
Active

Outcomes
Primary outcome [1] 3880 0
Difference in weight between intervention and control, measured using calibrated digital scale
Timepoint [1] 3880 0
12 months
Primary outcome [2] 3901 0
Difference in weight at 4 months between intervention and control, measured using weighed measures at baseline and self reported weight at 4 months.
Timepoint [2] 3901 0
4 months
Secondary outcome [1] 6524 0
Difference in physical actvity behaviors between intervention and control measured using self reported questionnaires and step counts using research pedometer taped closed to avoid feedback to participants
Timepoint [1] 6524 0
12 months
Secondary outcome [2] 6576 0
Difference in fasting glucose and blood lipids, measured using fresh blood samples.
Timepoint [2] 6576 0
12 months
Secondary outcome [3] 6577 0
Difference in dietary intake between intervention and control groups, measured using Food Frequency Questionnaires
Timepoint [3] 6577 0
12 months

Eligibility
Key inclusion criteria
Generally healthy mothers of at least one child (aged 5-13) attending primary school
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant, breast feeding infants under 6 months, wishing to gain weight, serious physical or psychological illness preventing participation

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)
Identify all primary schools within one local government area. Randomise schools to intervention or control using computer generated numbers. Recruited women are allocated to intervention or control as a school cluster to avoid contamination. Research team is aware of allocation as they are implementing intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Schools are paired with a school of similar size based on enrollment numbers. Random numbers were generated in Excell software and listed against the schools. The largest number of each pair allocated to intervention the smaller number to control
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster randomised. The item being the school. Data analysed at the individual level
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3117 0
Charities/Societies/Foundations
Name [1] 3117 0
William Buckland Foundation
Country [1] 3117 0
Australia
Primary sponsor type
Individual
Name
Catherine Lombard
Address
49-51 Kanooka Grove, Clayton, 3168
Country
Australia
Secondary sponsor category [1] 2805 0
Individual
Name [1] 2805 0
Prof Helena Teede
Address [1] 2805 0
49-51 Kanooka Grove Clayton 3168
Country [1] 2805 0
Australia
Other collaborator category [1] 212 0
Charities/Societies/Foundations
Name [1] 212 0
Jean Hailes Foundation for Women's Health
Address [1] 212 0
173 Caranish Road, Clayton 3168
Country [1] 212 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5094 0
Southern Health and Monash Univestiy Human Ethics
Ethics committee address [1] 5094 0
Locked bag 29, Monash Medical Centre, melbourne
Ethics committee country [1] 5094 0
Australia
Date submitted for ethics approval [1] 5094 0
15/12/2005
Approval date [1] 5094 0
30/03/2006
Ethics approval number [1] 5094 0
05187C

Summary
Brief summary
This 12month low intensity, randomised controlled intervention is delivered in conjunction with primary schools. It builds on the exisiting community efforts to control the prevalence of obesity and related disorders. It addresses barriers to attendance and is low cost and adaptable to communities
Trial website
www.jeanhailes.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28397 0
Address 28397 0
Country 28397 0
Phone 28397 0
Fax 28397 0
Email 28397 0
Contact person for public queries
Name 11554 0
Catherine Lombard
Address 11554 0
Jean Hailes Foundation for Women Health
173 Carinish Road , Clayton, 3168
Country 11554 0
Australia
Phone 11554 0
0395947545
Fax 11554 0
Email 11554 0
[email protected]
Contact person for scientific queries
Name 2482 0
Catherine Lombard
Address 2482 0
49-51 Kanooka Grove, Clayton 3168
Country 2482 0
Australia
Phone 2482 0
03 95947545
Fax 2482 0
Email 2482 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
EmbasePreventing weight gain: The baseline weight related behaviors and delivery of a randomized controlled intervention in community based women.2009https://dx.doi.org/10.1186/1471-2458-9-2
N.B. These documents automatically identified may not have been verified by the study sponsor.