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

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: ACTRN12615000400561 , Universal Trial Number: U1111-1155-0409. Date registered: 29^th April 2015.

Keywords: Birthweight; Gestational weight gain; Nutritional intervention; Obesity; Probiotics; Randomised controlled trial; Study protocol.

Fig. 1

Overview of recruitment and randomisation in the HUMBA study

Fig. 2

Research plan flow chart for the HUMBA study. * Fasting, one-hour and two-hour glucose after 75 g glucose load. ** Women randomised to the dietary intervention will be seen 4 times at 2–3 weekly intervals between recruitment and the 26–28 week OGTT