Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000453381
Ethics application status
Approved
Date submitted
29/08/2008
Date registered
15/09/2008
Date last updated
30/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dietary fat and the management of overweight
Scientific title
Delivering essential fatty acids in the management of overweight
Universal Trial Number (UTN)
Trial acronym
Healthy Eating & Lifestyle Program – The HELP Diet
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity 3622 0
Condition category
Condition code
Diet and Nutrition 3783 3783 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arms received dietary advice to include polyunsaturated fatty acids (PUFA) rich foods into their daily diet for 3 months. Participants see dietitians on a monthly basis, approximately 1 hour each session, for dietary education and support and handout on the number of serves of foods was given to each participant.

Group 1: higher polyunsaturated fatty acid diet and energy balance

Group 2: higher polyunsaturated fatty acid diet plus energy deficit (deficit of 2 mega joule per day)
Intervention code [1] 3333 0
Lifestyle
Comparator / control treatment
Control arms received dietary advice to limit dietary fat intake to lower than 30% of daily energy consumption for 3 months. Participants also see dietitians on a monthly basis, approximately 1 hour each session, for dietary advice and support where handout on the number of serves of foods were also given.

Group 1: 30% fat and energy balance

Group 2: 30% fat plus energy deficit (deficit of 2 mega joule per day)
Control group
Active

Outcomes
Primary outcome [1] 4675 0
Visceral adipose tissue measured using the computed tomography (CT) scan method
Timepoint [1] 4675 0
at 0 and 3 months
Primary outcome [2] 4676 0
Body weight in kilogram measured using a Tanita scale, accurate to 0.1 kilogram
Timepoint [2] 4676 0
Baseline, 1, 2 and 3 months
Primary outcome [3] 4677 0
Body fat percentage using the leg-to-leg bio-electrical impedence scale (tanita scale)
Timepoint [3] 4677 0
Baseline, 1, 2 and 3 months
Secondary outcome [1] 7896 0
24-hour energy expenditure measured using the human whole room calorimeter located in the University of Wollongong
Timepoint [1] 7896 0
Twice, at 0 and 3 months of the study
Secondary outcome [2] 7897 0
fasting blood leptin, insulin and glucose, sample were obtained by trained clinical staff and tests outsourced to the Southern Pathology Company
Timepoint [2] 7897 0
At 0 and 3 months

Eligibility
Key inclusion criteria
Overweight but otherwise healthy, with body mass index range between 25-38kg/m2, willing to follow dietary prescription
Minimum age
18 Years
Maximum age
67 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
pergnancy, breast feeding, wear a pacemaker, regulat cigarette smoking, regular medication, food allergies

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This was done at central administration where the allocation schedule is held
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
this was done using a computer software (computerised sequence generation
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
Completed
Date of first participant enrolment
Anticipated
7/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3798 0
Government body
Name [1] 3798 0
National Health & Medical Research Council (NHMRC)
Country [1] 3798 0
Australia
Primary sponsor type
University
Name
Smart Foods Centre
Address
University of Wollongong
Northfields Avenue
Wollongong NSW 2522
Country
Australia
Secondary sponsor category [1] 3408 0
None
Name [1] 3408 0
Address [1] 3408 0
Country [1] 3408 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5856 0
University of Wollongong human research ethics committee
Ethics committee address [1] 5856 0
Ethics committee country [1] 5856 0
Australia
Date submitted for ethics approval [1] 5856 0
Approval date [1] 5856 0
07/01/2005
Ethics approval number [1] 5856 0
HE04/326

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

Contacts
Principal investigator
Name 28884 0
Address 28884 0
Country 28884 0
Phone 28884 0
Fax 28884 0
Email 28884 0
Contact person for public queries
Name 12041 0
Mrs. Jane O'Shea
Address 12041 0
Smart Foods Centre
University of Wollongong
Northfields Avenue
Wollongong NSW 2522
Country 12041 0
Australia
Phone 12041 0
02 4221 5124
Fax 12041 0
02 4221 4844
Email 12041 0
[email protected]
Contact person for scientific queries
Name 2969 0
Prof. Linda Tapsell
Address 2969 0
Smart Foods Centre
University of Wollongong
Northfields Avenue
Wollongong NSW 2522
Country 2969 0
Australia
Phone 2969 0
02 4221 3152
Fax 2969 0
02 4221 4844
Email 2969 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 AIIncreased Intake of Dietary Polyunsaturated Fat Does Not Promote Whole Body or Preferential Abdominal Fat Mass Loss in Overweight Adults2011https://doi.org/10.1159/000333433
N.B. These documents automatically identified may not have been verified by the study sponsor.