Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001653257
Ethics application status
Approved
Date submitted
3/09/2018
Date registered
5/10/2018
Date last updated
3/07/2019
Date data sharing statement initially provided
3/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of hormones involved in appetite regulation after return to pre-pregnancy weight in women with and without post-partum weight retention
Scientific title
Evaluation of hormones involved in appetite regulation after return to pre-pregnancy weight in women with and without post-partum weight retention
Secondary ID [1] 295745 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-pregnancy weight gain 309143 0
Condition category
Condition code
Diet and Nutrition 308028 308028 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be conducted at the Metabolic Disorders Centre, Department of Medicine, University of Melbourne (Austin Health). Women who are 10% or more above their pre-pregnancy weight (group B) will undergo a weight loss intervention. Guidance on following a hypocaloric diet will be provided face-to-face by a qualified dietitian, every 2 weeks until weight loss of at least 10% (to pre-pregnancy weight) is achieved. Each visit may take 10-45 mins, at the discretion of the dietitian according to participant needs. The diet will be in accordance with the ‘Australian Guide to Healthy Eating’, aiming for loss of 1 kg per week until they return to their pre-pregnancy weight and if required, meal replacements (Optifast VLCD), will be added up to 2 times per day to facilitate weight loss. The maximum duration of the intervention will be 6 months.
Intervention code [1] 312072 0
Lifestyle
Comparator / control treatment
Group A: no intervention (participants will already have returned to their pre-pregnancy weight)
Control group
Active

Outcomes
Primary outcome [1] 307014 0
Plasma leptin, per kg of fat mass
Timepoint [1] 307014 0
Four weeks after return to pre-pregnancy weight (estimated to take up to 3 months in group B, and at study entry in group A). Leptin/fat mass for women who do not return to their pre-pregnancy weight will not be included in the primary outcome.
Secondary outcome [1] 350358 0
Changes in circulating (blood) levels of hormones involved in the compensatory response to weight loss (exploratory)
Timepoint [1] 350358 0
From baseline (pre-weight loss) to after return to pre-pregnancy weight (group B)
Secondary outcome [2] 350359 0
DNA methylation profiles at weight-relevant loci (exploratory) in peripheral blood cells
Timepoint [2] 350359 0
12 months post-partum

Eligibility
Key inclusion criteria
Women with no previous history of obesity, who were normal weight (BMI 18.5-24.9 kg/m2) prior to a recent term (37+ weeks) singleton pregnancy, and are now 12 (± 2) months post-partum. Two groups of women will be recruited: those who have returned to within 2kg of their pre-pregnancy weight (group A), and those who remain 10% or more above pre-pregnancy weight (group B).
Minimum age
20 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently pregnant, smoking or taking medications which may affect weight

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Women in group A will already have returned to their pre-pregnancy weight prior to entry into the study. Women who remain 10% or more above their pre-pregnancy weight (group B) will be prescribed a hypocaloric diet until they return to their pre-pregnancy weight.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Based on published data of expected values for leptin per kg fat mass in normal-weight women, and its magnitude of change with weight loss of 10%, we estimate requiring 35 women per group for 80% power for the primary outcome of leptin/kg fat mass after return to pre-pregnancy weight. For the primary outcome, comparisons will be made using independent sample t tests, and linear regression analyses will also be performed to adjust for baseline covariates, assess and account for confounders. Secondary outcomes will be analysed using regression models, adjusting for baseline covariates.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
8/10/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11593 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 23636 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 300336 0
Charities/Societies/Foundations
Name [1] 300336 0
Sir Edward Dunlop Medical Research Foundation
Country [1] 300336 0
Australia
Primary sponsor type
Individual
Name
Priya Sumithran
Address
Austin Health
300 Waterdale Rd
Heidelberg West VIC 3081
Country
Australia
Secondary sponsor category [1] 299775 0
None
Name [1] 299775 0
N/A
Address [1] 299775 0
N/A
Country [1] 299775 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301148 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 301148 0
Ethics committee country [1] 301148 0
Australia
Date submitted for ethics approval [1] 301148 0
19/05/2018
Approval date [1] 301148 0
30/08/2018
Ethics approval number [1] 301148 0
HREC/18/Austin/257

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

Contacts
Principal investigator
Name 86014 0
Dr Priya Sumithran
Address 86014 0
Austin Health
300 Waterdale Rd
Heidelberg West VIC 3081
Country 86014 0
Australia
Phone 86014 0
+61394962375
Fax 86014 0
Email 86014 0
[email protected]
Contact person for public queries
Name 86015 0
Priya Sumithran
Address 86015 0
Austin Health
300 Waterdale Rd
Heidelberg West VIC 3081
Country 86015 0
Australia
Phone 86015 0
+61394962375
Fax 86015 0
Email 86015 0
[email protected]
Contact person for scientific queries
Name 86016 0
Priya Sumithran
Address 86016 0
Austin Health
300 Waterdale Rd
Heidelberg West VIC 3081
Country 86016 0
Australia
Phone 86016 0
+61394962375
Fax 86016 0
Email 86016 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


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.