Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000784011
Ethics application status
Approved
Date submitted
8/09/2010
Date registered
21/09/2010
Date last updated
14/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the importance of food choices in a healthy lifestyle for weight control.
Scientific title
Will a higher vegetable consumption result in greater long term weight loss in overweight, but otherwise healthy adults?
Secondary ID [1] 252657 0
VG09037 Horticulture Australia Ltd
Universal Trial Number (UTN)
U1111-1116-8433
Trial acronym
Healthy Eating and Lifestyle (HEAL) Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 258152 0
Condition category
Condition code
Diet and Nutrition 258330 258330 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Isocaloric diet with 5 serves vegetables per day for 12 months. Participants will be advised on a diet plan in terms of the amounts and types of food groups as outlined in the Australian Guide to Healthy Eating. Energy requirements will not be specifically restricted but energy dense nutrient poor foods will be excluded (cakes, biscuits, soft drinks) and this will likely reduce energy intake, that is, the energy value of the trial dietary patterns is likey to be reduced with this dietary advice strategy. Initial dietary counselling sessions one on one with the dietitian will take one hour and follow up sessions at month 1,2,3, 6, 9, 12 will take 30 minutes. Between visits, SMS messages and emails will be sent fortnightly to provde behavioural support.
Intervention code [1] 257169 0
Lifestyle
Intervention code [2] 257206 0
Prevention
Intervention code [3] 257207 0
Other interventions
Comparator / control treatment
The control arm will receive the same level of intervention and background dietary advice as the intervention group, but vegetables will not be emphasised in reference to food groups and the portion sizes of the vegetable categories for the intervention group will be twice that indicated in the educational material for the control group. Additional material will be provided to the intervention group on how to incorporate vegetables into meals and recipes. It is anticipated the control group will eat half the amount of vegetables than the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 259183 0
Body weight which will be measured in an upright position in minimal clothing and without shoes using scales with a bio-electrical impedance component (Tanita).
Timepoint [1] 259183 0
Measurements will be taken at baseline, and at 3, 6, 9 and 12 time points.
Primary outcome [2] 259184 0
Amounts and types of vegetables consumed per day assessed by 4-day food diaries and diet history interviews.
Timepoint [2] 259184 0
Measurements will be taken at baseline, and at 3, 6, 9 and 12 time points.
Secondary outcome [1] 265535 0
Anti-oxidant status assessed by assessing plasma F2 isoprostane levels using Gas Chromatography - Mass Spectometry (GCMS) techiques.
Timepoint [1] 265535 0
Measurements will be taken at baseline, and at 3 and 12 time points.
Secondary outcome [2] 265536 0
Total cholesterol, Low Density Lipoprotein (LDL) cholesterol, High Density Lipoprotein (HDL) cholesterol and triglycerides assessed by fasting blood samples sent to a quality assured pathology laboratory. (Southerin Illawarra Medical Laboratory (IML) Pathology)
Timepoint [2] 265536 0
Measurements will be taken at baseline, and at 3, 6, 9 and 12 time points.
Secondary outcome [3] 265537 0
Glucose and Insulin assessed by fasting blood samples sent to a quality assured pathology laboratory. (Southerin IML Pathology)
Timepoint [3] 265537 0
Measurements will be taken at baseline, and at 3, 6, 9 and 12 time points.
Secondary outcome [4] 265538 0
Greater acceptability of vegetables and perceptions of satiety assessed by questionnaire.
Timepoint [4] 265538 0
Measurements will be taken at baseline, and at 3, 6, 9 and 12 time points.

Eligibility
Key inclusion criteria
Body Mass Index (BMI) below 25 and equal to or above 35kg/m2
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Major illnesses, Type 1 and Type 2 diabetes mellitus, thyroid abnormalities, history of heavy alcohol consumption, rcent acute or chronic disease likely toa ffect results; changing medications that may affect body weight; weight loss . 5kg in last 3 months; widely fluctuating exercise patterns; strenuous exercies > 1 hour per day, food allergies or avoidance of major food groups, strict dietary avoidance (including extreme vegetarianism) dislike of vegetables.

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)
Potential participants will be drawn from the general public through media advertisements, emails and through flyers. Volunteers will complete a screening questionnaire to confirm eligibility and will attend an initial assessment session. Dietitians who collect dietary data will be different to those who give dietary advice. It will not be possible to blind the dietitians but the participants iwll not be informed as to their diet group allocation.

Randomization will be performed by a single researcher who will be independent to the participant interface.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
stratified (sex) permuted block randomisation using computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All continuous variables were analysed using a linear mixed model, conducted using intention to treat analysis at the completion of the trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/09/2010
Actual
21/10/2010
Date of last participant enrolment
Anticipated
13/01/2011
Actual
8/02/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 6970 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 257619 0
Commercial sector/Industry
Name [1] 257619 0
Horticulture Australia Limited
Country [1] 257619 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Smart Foods Centre, University of Wollongong, Northfields Avenue, Wollongong, NSW, 2522
Country
Australia
Secondary sponsor category [1] 256840 0
None
Name [1] 256840 0
Address [1] 256840 0
Country [1] 256840 0
Other collaborator category [1] 251487 0
University
Name [1] 251487 0
Curtin University of Technology
Address [1] 251487 0
Kent Street, Bentley, WA, 6102
Country [1] 251487 0
Australia
Other collaborator category [2] 251488 0
University
Name [2] 251488 0
University of Queensland
Address [2] 251488 0
Brisbane Street, St Lucia, QLD, 4072
Country [2] 251488 0
Australia
Other collaborator category [3] 251489 0
Government body
Name [3] 251489 0
Queensland Department of Employment Economic Development and Innovation
Address [3] 251489 0
PO Box 156, Archerfield BC, QLD, 4108
Country [3] 251489 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259635 0
Human Research and Ethics Committee
Ethics committee address [1] 259635 0
Ethics committee country [1] 259635 0
Date submitted for ethics approval [1] 259635 0
Approval date [1] 259635 0
15/07/2010
Ethics approval number [1] 259635 0
HREC 10/192

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

Contacts
Principal investigator
Name 31621 0
Prof Linda Tapsell
Address 31621 0
Smart Foods Centre
Faculty of Science, Medicine and Health
University of Wollongong NSW 2522
Australia
Country 31621 0
Australia
Phone 31621 0
+61 2 4221 3152
Fax 31621 0
+61 2 4221 4844
Email 31621 0
[email protected]
Contact person for public queries
Name 14868 0
Linda Tapsell
Address 14868 0
Smart Foods Centre
University of Wollongong
Northfields Avenue
Wollongong NSW 2522
Country 14868 0
Australia
Phone 14868 0
+61 2 4221 3152
Fax 14868 0
+61 2 4221 4844
Email 14868 0
[email protected]
Contact person for scientific queries
Name 5796 0
Linda Tapsell
Address 5796 0
Smart Foods Centre
University of Wollongong
Northfields Avenue
Wollongong NSW 2522
Country 5796 0
Australia
Phone 5796 0
+61 2 4221 3152
Fax 5796 0
+61 2 4221 4844
Email 5796 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

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