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BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2016

Open Access 01-12-2016 | Study protocol

A randomised controlled demonstration trial of multifaceted nutritional intervention and or probiotics: the healthy mums and babies (HUMBA) trial

Authors: Karaponi Okesene-Gafa, Minglan Li, Rennae S. Taylor, John M. D. Thompson, Caroline A. Crowther, Christopher J. D. McKinlay, Lesley M. E. McCowan

Published in: BMC Pregnancy and Childbirth | Issue 1/2016

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Abstract

Background

Maternal obesity is associated with adverse pregnancy outcomes and has lifelong negative implications for offspring health. The Institute of Medicine recommends limited gestational weight gain (GWG) in obese women for optimal maternal and infant outcomes. However, there is a gap regarding an effective and sustainable intervention strategy to achieve this goal. The aim of the healthy mums and babies (HUMBA) demonstration trial is to assess whether a multifaceted nutritional intervention and/or an oral probiotic treatment in obese pregnant women can reduce excessive GWG and optimise pregnancy outcomes.

Methods and design

The study is a two by two factorial randomised controlled demonstration trial conducted in Counties Manukau health region, New Zealand, a multi-ethnic region with a high prevalence of obesity. A total of 220 non-diabetic obese women with a singleton pregnancy will be recruited between 120 and 176 weeks. At recruitment, women are randomised to receive either a culturally tailored multifaceted dietary intervention or routine dietary advice, and either an oral probiotic or placebo capsule. Randomisation is undertaken via a web-based protocol, randomize.net, with a 1:1 ratio using stratification by body mass index (BMI) category (BMI of 30–34.9 or BMI ≥35 kg/m2). The dietary intervention includes 4 customised nutrition education visits by a trained community health worker combined with motivational text messaging. Probiotic capsules consist of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 at a dose of 7 × 109 colony-forming units one per day until birth. Probiotic and placebo capsules are identically pre-packed and labelled by a third party, and are prescribed in a double blinded fashion. Research assessments are conducted at enrolment, 28 weeks, 36 weeks, at birth and at 5 months post-delivery. The primary outcomes for the study are proportion of women with excessive GWG and infant birthweight.

Discussion

The HUMBA demonstration trial will assess the efficacy of a culturally tailored multifaceted dietary intervention and probiotic treatment in limiting excessive GWG and optimising birthweight in a multiethnic sample of obese pregnant women. If successful, either one or both of the interventions may be incorporated into future studies powered to investigate important pregnancy outcomes.

Trial registration

Australian New Zealand Clinical Trials Registry registration number: ACTRN12615000400​561, Universal Trial Number: U1111-1155-0409. Date registered: 29th April 2015.
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Metadata
Title
A randomised controlled demonstration trial of multifaceted nutritional intervention and or probiotics: the healthy mums and babies (HUMBA) trial
Authors
Karaponi Okesene-Gafa
Minglan Li
Rennae S. Taylor
John M. D. Thompson
Caroline A. Crowther
Christopher J. D. McKinlay
Lesley M. E. McCowan
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2016
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-016-1149-8

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