ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

Trial acronym

TRiM

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Postpartum weight retention

Dietary intake/diet quality

Insulin resistance

Condition category

Condition code

Diet and Nutrition

Obesity

Reproductive Health and Childbirth

Childbirth and postnatal care

Metabolic and Endocrine

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]

Behaviour

Intervention code [2]

Lifestyle

Intervention code [3]

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]

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]

36 weeks pregnancy, 6 weeks postpartum, 6 months post partum

Secondary outcome [1]

1. have significantly better diet quality (using validated diet quality questionnaire -the 'Fat and Fibre' index)

Timepoint [1]

36 weeks pregnancy, 6 weeks postpartum, 6 months post partum

Secondary outcome [2]

2. undertake significantly more minutes of physical activity (AWAS - valid and reliable Australian Women's Activity Survey)

Timepoint [2]

36 weeks pregnancy, 6 weeks postpartum, 6 months post partum

Secondary outcome [3]

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]

6 weeks postpartum, 6 months post partum

Secondary outcome [4]

4. have significantly better fasting glucose and insulin levels (clinical measurements - blood tests)

Timepoint [4]

36 weeks pregnancy, 6 weeks postpartum, 6 months post partum

Secondary outcome [5]

5. significantly lower fat mass (FM) and significantly higher fat free mass (FFM).

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Mater Health Services (Golden Casket Funding Round)

Address [1]

Raymond Terrace, South Brisbane, Queensland, 4101

Country [1]

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]

Individual

Name [1]

Prof H David McIntyre

Address [1]

Director of Obstetric Medicine,Mater Health Services,
Raymond Terrace, South Brisbane, Queensland, 4101

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

A/Prof Vicki Flenady

Address [1]

Director of the Centre of Translating Research into Practice,
Mater Medical Research Institute,
Raymond Terrace, South Brisbane, Queensland, 4101

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Human Ethics Research Committee

Ethics committee address [1]

Mater Medical Research Institute, Aubigny Place, Raymond Terrace, South Brisbane, 4101, Queensland

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

25/06/2010

Ethics approval number [1]

1508M

Summary

Brief summary

Retention of weight gained during pregnancy contributes to overweight and obesity and subsequent chronic disease risk, with the associated personal, financial and public health burdens. Women who are overweight or obese at beginning of pregnancy are more likely to gain excess weight and retain this weight after pregnancy. Women who do not lose weight by 6 months postpartum are more likely to be overweight or obese over the long term. 

Approximately one third of women who deliver at the MMH are overweight or obese at the beginning of pregnancy. A 2008 MMH Nutrition and Dietetic audit demonstrated that, of the 102 women surveyed, 50% of the women who were overweight, 75% of women who were obese and 100% of women who were morbidly obese gained in excess of their recommended weight gain range for pregnancy. Our MMH patients are at very high risk of retaining weight after pregnancy and developing associated chronic diseases, thus implementation of weight management interventions is urgently required. 

Limited data exist regarding the most effective methods of supporting weight loss after pregnancy. However, diet and exercise, with behavioural change and support are known to be important elements to be included in any program. Usual models of weight loss care (e.g. multiple group/clinic attendances) are not as appropriate in this population group due to childrearing demands. 

Our research aim is to develop, implement and evaluate an innovative postpartum weight management program that includes evidence-based behaviour change strategies to support postpartum weight management that is delivered in a format suitable for MMH postnatal (PN) patients.

Trial website

Trial related presentations / publications

Wilkinson, SA., van der Pligt, P., Gibbons, K.S., & McIntyre, H.D. (2013). Trial for Reducing Weight Retention in New Mums (TRiM): A randomised controlled trial evaluating a low intensity, postpartum weight management program. Journal of Human Nutrition and Dietetics. EPub. DOI: 10.1111/jhn.12193

Wilkinson, SA. Gibbons, KS. & McIntyre, HD. Trial for the reduction of weight retention in new mums (TRiM): a randomised controlled trial investigating the effectiveness of an innovative, low intensity postpartum weight management program weight management program. 30th National Conference, Dietitians Association of Australia. Canberra, Australia, 23-25 May, 2013.

Public notes

Contacts

Principal investigator

Name

Dr Shelley Wilkinson

Address

Dept of Dietetics
Mater Health Services
MCH - level 3, Allied Health, Raymond Tce
South Brisbane, Queensland. 4101

Country

Australia

Phone

+61 7 3163 6000

Fax

shelley.wilkinson@mater.org.au

Contact person for public queries

Name

Dr Shelley Wilkinson

Address

c/o- Dept Nutrition and Dietetics
Mater Health Services
Lvl 3, MCH
Raymond Terrace
South Brisbane
Queensland, 4101

Country

Australia

Phone

+61 7 3163 8585

Fax

+61 7 3163 8585

shelley.wilkinson@mater.org.au

Contact person for scientific queries

Name

Dr Shelley Wilkinson

Address

c/o- Dept Nutrition and Dietetics
Mater Health Services
Lvl 3, MCH
Raymond Terrace
South Brisbane
Queensland, 4101

Country

Australia

Phone

+61 7 3163 8585

Fax

shelley.wilkinson@mater.org.au

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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Documents added automatically

No additional documents have been identified.

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