Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000197831
Ethics application status
Approved
Date submitted
9/02/2012
Date registered
15/02/2012
Date last updated
28/11/2019
Date data sharing statement initially provided
28/11/2019
Date results provided
28/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of intermittent dieting on weight loss in overweight and obese females
Scientific title
The effect of intermittent energy restriction compared to continuous energy restriction on weight loss in healthy overweight to obese females
Secondary ID [1] 279910 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
overweight 285820 0
Obesity 285850 0
Condition category
Condition code
Diet and Nutrition 285998 285998 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volunteers will be assigned to one of two groups for an 8-week study. One group will diet continuously while the other will diet intermittently: 1 week dieting with an energy intake of no more than 5.5Mj, 1 week not dieting (no energy restriction), throughout the 8 weeks. Instruction in how to achieve the energy level of 5.5 MJ will be given at the beginning of the study and dietary advise will be given at every other week for 8 weeks. The continuous dieting group will be instructed in how to achieve the 5.5MJ and reinforcement will be given at fortnightly visits for 8 weeks. A food frequency questionnaire will be completed and dietary education will be delivered in a group session at UniSA at the beginning of the study and each volunteer will be weighed and measured privately every two weeks. The first visit will take approximately an hour; follow up visits will be shorter. A 1-year follow up visit will also be held to assess the long term effect.
Intervention code [1] 284235 0
Treatment: Other
Intervention code [2] 284266 0
Lifestyle
Intervention code [3] 284267 0
Behaviour
Comparator / control treatment
The level of energy restricted diet will give 5500 kJ/day. “Total Wellbeing Diet” book will be used.
The volunteers will be instructed to consume a 5.5MJ diet for the duration of the study in the continuous energy restricted group. In the intermittent energy restricted group volunteers will be instructed in consuming a 5.5MJ diet in alternate weeks, starting the week of commencement. In the following week the volunteers will consume their usual diet.
The TWD book will be given to all volunteers. The “system” will be explained and example diet plan handed out.
Control group
Active

Outcomes
Primary outcome [1] 286488 0
Weight loss will be assessed using digital weighting scales
Timepoint [1] 286488 0
eight weeks and 12 months
Secondary outcome [1] 296002 0
Waist to hip circumference
Timepoint [1] 296002 0
baseline eight weeks and 12 months

Eligibility
Key inclusion criteria
Women over age 18
Body mass index (BMI) >27 kg/m2
No concomitant serious illness
Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion: Previous surgery for weight reduction
Pregnant or breast feeding women
Alcohol intake in excess of 5 standard drinks per day
Participation in other ongoing trials aiming at altering energy or macronutrient intake

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)
Participants will be divided into groups according to BMI and age.

Participants will be randomized using the minimization method, sealed envolopes containing the diet allocation will be used
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic randomization using minimization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
To show if intermittent dieting is as or more effective in producing weight loss compared to continuous dieting
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/02/2012
Actual
13/03/2012
Date of last participant enrolment
Anticipated
Actual
20/03/2012
Date of last data collection
Anticipated
Actual
15/05/2013
Sample size
Target
60
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 284689 0
University
Name [1] 284689 0
University of South Australia, School of Pharmacy and Medical Sciences
Country [1] 284689 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO BOX 2471, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 283616 0
None
Name [1] 283616 0
Address [1] 283616 0
Country [1] 283616 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286683 0
Human Ethics Commitee of University of South Australia
Ethics committee address [1] 286683 0
Ethics committee country [1] 286683 0
Australia
Date submitted for ethics approval [1] 286683 0
Approval date [1] 286683 0
08/02/2012
Ethics approval number [1] 286683 0
0000027538

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

Contacts
Principal investigator
Name 33757 0
A/Prof Jennifer Keogh
Address 33757 0
University of South Australia, GPO Box 2471, Adelaide SA 5001
Country 33757 0
Australia
Phone 33757 0
+61 8 8302 2579
Fax 33757 0
Email 33757 0
[email protected]
Contact person for public queries
Name 17004 0
Ass Professor Dr. Jennifer Keogh
Address 17004 0
University of South Australia, GPO Box 2471, Adelaide SA 5001
Country 17004 0
Australia
Phone 17004 0
+61 8 8302 2579
Fax 17004 0
Email 17004 0
[email protected]
Contact person for scientific queries
Name 7932 0
Ass Professor Dr. Jennifer Keogh
Address 7932 0
University of South Australia, GPO Box 2471, Adelaide SA 5001
Country 7932 0
Australia
Phone 7932 0
+61 8 8302 2579
Fax 7932 0
Email 7932 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD data for this trial will be available as this has not been approved by Ethics.


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
No additional documents have been identified.