Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000873921
Ethics application status
Approved
Date submitted
9/08/2011
Date registered
16/08/2011
Date last updated
3/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
TRiM – Trial for Reducing Weight Retention in New Mums: A randomised controlled trial investigating the effectiveness of an innovative postpartum weight loss program.
Scientific title
A randomised controlled trial investigating the effectiveness of an innovative postpartum weight loss program in new mothers.
Secondary ID [1] 262809 0
nil
Universal Trial Number (UTN)
Trial acronym
TRiM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postpartum weight retention 270515 0
Dietary intake/diet quality 270516 0
Insulin resistance 270518 0
Condition category
Condition code
Diet and Nutrition 270680 270680 0 0
Obesity
Reproductive Health and Childbirth 270681 270681 0 0
Childbirth and postnatal care
Metabolic and Endocrine 270683 270683 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Delivery of a program that combines self-monitoring delivered in a low-intensity delivery format (email and/or postal), paired with evidence-based postnatal nutrition and healthy lifestyle information - initiated in the late antenatal period through to 6 months postpartum. The intervention starts with a 1 hour nutrition assessment, goal setting and counselling session (delivered antenatally at approximately 36 weeks) delivered in line with the Australian Guide to Healthy Eating (+/- kilojoule restriction of 2000kJ/day, depending on lactation status), followed by fortnightly information and goal setting sheets posted from 6 weeks until 3 months postpartum, then monthly until 6 months. The sheets contain information on: nutrition post-pregnancy (+/-breastfeeding) + self monitoring (food groups; weight), practical ideas for cooking, shopping, larder, fridge, freezer; physical activity; balanced life.
Intervention code [1] 269158 0
Behaviour
Intervention code [2] 269176 0
Lifestyle
Intervention code [3] 269186 0
Treatment: Other
Comparator / control treatment
Delivery of basic nutrition for breastfeeding information in the late antenatal period (Provision of ‘Healthy Eating for Breastfeeding’ diet sheet (5 minutes) at 36 weeks postpartum)
Control group
Active

Outcomes
Primary outcome [1] 269398 0
Our primary hypothesis is that women in the intervention group will lose significantly more weight than women in the control group. This will be determined through an anthropometric assessment (weight will be measured to the nearest 0.1 kg using a spring balance scale).
Timepoint [1] 269398 0
36 weeks pregnancy, 6 weeks postpartum, 6 months post partum
Secondary outcome [1] 287551 0
1. have significantly better diet quality (using validated diet quality questionnaire -the 'Fat and Fibre' index)
Timepoint [1] 287551 0
36 weeks pregnancy, 6 weeks postpartum, 6 months post partum
Secondary outcome [2] 287597 0
2. undertake significantly more minutes of physical activity (AWAS - valid and reliable Australian Women's Activity Survey)
Timepoint [2] 287597 0
36 weeks pregnancy, 6 weeks postpartum, 6 months post partum
Secondary outcome [3] 287598 0
3. demonstrate significantly higher breastfeeding rates
(valid and reliable breastfeeding (and breastfeeding intention- survey from Nommsen-Rivers & Dewey (2009) Development and validation of the infant feeding intentions scale. Matern Child Health J, 13:334-342).
Timepoint [3] 287598 0
6 weeks postpartum, 6 months post partum
Secondary outcome [4] 287599 0
4. have significantly better fasting glucose and insulin levels (clinical measurements - blood tests)
Timepoint [4] 287599 0
36 weeks pregnancy, 6 weeks postpartum, 6 months post partum
Secondary outcome [5] 287600 0
5. significantly lower fat mass (FM) and significantly higher fat free mass (FFM).
Timepoint [5] 287600 0
Bioelectrocal impedence assay; 6 weeks postpartum, 6 months post partum

Eligibility
Key inclusion criteria
pre-pregnancy BMI > 25kg/m2, can read and speak English to a level that allows completion of intervention worksheets, and > 18years.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
live outside the MMH catchment area, have delivered <36/40, have a pre-pregnancy diagnosis of type 1 or type 2 diabetes mellitus, or have a history of substance use or have a severe medical or psychological diagnosis that would prevent participation within the intervention

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)
The research midwife will approach eligible women at their 24th or 28th week antenatal clinic appointment and will enrol those who provide consent. Details will be provided to the research dietitian who will randomly allocate women to SC (supported care) or EC (enhanced care) based on envelopes provided by the Mater Medical Research Institute.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Our method of randomisation was: stratified block randomisation using a randomisation table created by computer software; cards were produced and sealed in opaque envelopes for use by the research dietitian to allocate women following recruitment.

These have been stratified by BMI (25-30kg/m2; >30kg/m2).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
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
31/08/2010
Actual
31/08/2010
Date of last participant enrolment
Anticipated
Actual
7/07/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269632 0
Charities/Societies/Foundations
Name [1] 269632 0
Mater Health Services (Golden Casket Funding Round)
Country [1] 269632 0
Australia
Primary sponsor type
Individual
Name
Dr Shelley Wilkinson
Address
Senior Research Dietitian,
Mater Health Services,
Raymond Terrace, South Brisbane, Queensland, 4101
Country
Australia
Secondary sponsor category [1] 266662 0
Individual
Name [1] 266662 0
Prof H David McIntyre
Address [1] 266662 0
Director of Obstetric Medicine,Mater Health Services,
Raymond Terrace, South Brisbane, Queensland, 4101
Country [1] 266662 0
Australia
Other collaborator category [1] 252188 0
Individual
Name [1] 252188 0
A/Prof Vicki Flenady
Address [1] 252188 0
Director of the Centre of Translating Research into Practice,
Mater Medical Research Institute,
Raymond Terrace, South Brisbane, Queensland, 4101
Country [1] 252188 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269576 0
Mater Human Ethics Research Committee
Ethics committee address [1] 269576 0
Ethics committee country [1] 269576 0
Australia
Date submitted for ethics approval [1] 269576 0
Approval date [1] 269576 0
25/06/2010
Ethics approval number [1] 269576 0
1508M

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

Contacts
Principal investigator
Name 32997 0
Dr Shelley Wilkinson
Address 32997 0
Dept of Dietetics
Mater Health Services
MCH - level 3, Allied Health, Raymond Tce
South Brisbane, Queensland. 4101
Country 32997 0
Australia
Phone 32997 0
+61 7 3163 6000
Fax 32997 0
Email 32997 0
[email protected]
Contact person for public queries
Name 16244 0
Dr Shelley Wilkinson
Address 16244 0
c/o- Dept Nutrition and Dietetics
Mater Health Services
Lvl 3, MCH
Raymond Terrace
South Brisbane
Queensland, 4101
Country 16244 0
Australia
Phone 16244 0
+61 7 3163 8585
Fax 16244 0
+61 7 3163 8585
Email 16244 0
[email protected]
Contact person for scientific queries
Name 7172 0
Dr Shelley Wilkinson
Address 7172 0
c/o- Dept Nutrition and Dietetics
Mater Health Services
Lvl 3, MCH
Raymond Terrace
South Brisbane
Queensland, 4101
Country 7172 0
Australia
Phone 7172 0
+61 7 3163 8585
Fax 7172 0
Email 7172 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
No additional documents have been identified.