Core Outcome Measures in Effectiveness Trials

Network for Preconception and early Pregnancy Randomised Controlled Trials

General Information

Summary:
Mothers who are overweight and gain excess weight during pregnancy “transmit” a 33% increase risk of obesity to their children, driving the epidemic costing AU$58 billion per year.

Several centres around the world have recognised the need to intervene and break the cycle, earlier than has been previously attempted i.e. before pregnancy and in the first trimester of pregnancy. These are world first randomised controlled trials.

This project will integrate these studies at the design phases, consolidated by joint publications outlining optimal neonatal measures for fatness and heart health. Integrated outcome measures will create a node of comparable studies.

Contributors:
A/Prof Rae-Chi Huang, The University of Western Australia
Dr Adrienne Gordon, The University of Sydney
A/Prof Michael Skilton, The University of Sydney
Professor Lucilla Poston, King's College London
Professor Keith Godfrey, University of Southampton
Dr Mary Barker, University of Southampton
Dr Kyra Sim, The University of Sydney
Dr Nina D'Vaz, The University Western Australia

Further Study Information

Current Stage:
Ongoing
Date:
Funding source(s):
The University of Western Australia Research Collaboration Award

Health Area

Disease Category
Endocrine & metabolic
Neonatal care
Pregnancy & childbirth

Disease Name
Obesity

Target Population

Age Range
18 - 60

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Literature review

This project will:
1. Identify core neonatal outcomes for preconception and early pregnancy randomised controlled trials that aim to break the intergenerational cycle of obesity (and diabetes)
2. Build a network of studies to improve pregnancy in overweight and obese women through preconception and early gestation lifestyle programs.

The purpose of this collaboration is to coordinate neonatal outcomes for cardiovascular risk factors (including adiposity, and methods to quantify thickened arterial walls in infants). Integrated outcome measures will firstly set a solid framework for optimal study design and secondly form a node of comparable studies. The advantages of harmonisation of methods at the design phase will pay off in the future by allowing future joint meta-analyses.

This project will enhance existing strong collaborations between The University of Western Australia and the University of Southampton, who partly through facilitation of a previous University of Western Australia Research Collaboration Award, hold joint NHRMC project grants #APP1059711, (>AU$1M), Telethon Perth Children’s grant round two ($200K). This study was focussed on investigating early life origins of obesity. Therefore, this research collaboration award will now extend beyond the previous work, to stretch to translating these previous findings in randomised controlled trials.

On a practical level, these aims will be achieved by:

An initial systematic review: of newborn outcomes reported in randomised controlled trials of overweight/obese women pre or during pregnancy.

A Delphi process will categorise the outcomes highlighted in the systematic review and present these in online questionnaires.

The process will continue until whichever occurs first: reduction of the list of identified outcomes to ten or less; or on completion of the second round of voting.

Consensus face-to-face meeting between the research teams – Western Australia (PLAN), New South Wales (Pre-Plan), London (UpBEAT)., New Zealand,South Africa (SureStart)

PLAN (Team: Huang, D’Vaz, PhD Student): is a randomised trial which will intervene in early pregnancy (6-8 weeks gestation) to prevent excess weight gain during pregnancy through the use of technology to deliver lifestyle advice.

Pre-Plan (Team: Gordon, Sim): is a randomised controlled trial which intervenes to reduce obesity in the pre-conception period.

UPBEAT (Team Leader: Poston, Kings College): is investigating the potential benefit of a complex intervention in obese pregnant women. The intervention is delivered by health trainers and comprises a combination of dietary advice (focussing on low glycaemic index foods) and increasing physical activity. Following a successful feasibility pilot trial, a multicentre randomised controlled trial is now underway in London (Guys and St Thomas’ and King’s College Hospital Foundation Trusts)

Sure Start (Team leader: Barker): is a training intervention to improve diets and physical activity levels of disadvantaged women, that is being used in New Zealand, South Africa and the USA.


Stakeholders Involved

Clinical experts
Consumers (patients)
Economists
Epidemiologists
Families
Researchers
Service providers
Statisticians

Study Type

COS for clinical trials or clinical research
COS for practice

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