Original Research ajog.

org

OBSTETRICS
Effect of antenatal dietary interventions in maternal
obesity on pregnancy weight-gain and birthweight:
Healthy Mums and Babies (HUMBA) randomized trial
Karaponi A. M. Okesene-Gafa, FRANZCOG; Minglan Li, PhD; Christopher J. D. McKinlay, PhD; Rennae S. Taylor, MHSc;
Elaine C. Rush, PhD; Clare R. Wall, PhD; Jess Wilson, MSc; Rinki Murphy, FRACP; Rachael Taylor, PhD;
John M. D. Thompson, PhD; Caroline A. Crowther, MD, FRANZCOG; Lesley M. E. McCowan, MD, FRANZCOG

BACKGROUND: Pregnancy interventions that improve maternal and and demographic variables were similar across all groups. There was no
infant outcomes are urgently needed in populations with high rates of significant difference between intervention groups, for the co-primary
obesity. We undertook the Healthy Mums and Babies (HUMBA) randomized outcomes of (1) proportion of women with excessive gestational weight
controlled trial to assess the effect of dietary interventions and or probiotics gain (dietary intervention vs routine advice: 79/107 [73.8%] vs 90/110
in a multiethnic population of pregnant women with obesity, living in an [81.8%], adjusted relative risk [relative risk, 0.92; 95% confidence in-
area of high deprivation. terval, 0.80e1.05]; probiotics versus placebo: 89/108 [82.4%] and 80/
OBJECTIVES: To determine whether a culturally tailored dietary 109 [73.4%], relative risk, 1.14, 95% confidence interval, 0.99e1.31) or
intervention and or daily probiotic capsules in pregnant women with (2) birthweight (dietary intervention vs routine advice: 3575 vs 3612 g,
obesity reduces the co-primary outcomes of (1) excessive gestational adjusted mean difference, e24 g, 95% confidence interval, e146 to 97;
weight gain (mean >0.27 kg/week) and (2) birthweight. probiotics vs placebo: 3685 vs 3504 g, adjusted mean difference, 107 g,
STUDY DESIGN: We conducted a 2
2 factorial, randomized 95% confidence interval, e14 to 228). Total maternal weight gain, a
controlled trial in women without diabetes at pregnancy booking, body secondary outcome, was lower with dietary intervention compared with
mass index 30 kg/m2, and a singleton pregnancy. At 12þ0 to 17þ6 routine dietary advice (9.7 vs 11.4 kg, adjusted mean difference, e1.76,
weeks’ gestation, eligible women were randomized to a dietary inter- 95% confidence interval, e3.55 to 0.03). There were no significant dif-
vention (4 tailored educational sessions at 28 weeks’ gestation by a ferences between intervention groups in other secondary maternal or
community health worker trained in key aspects of pregnancy nutrition neonatal outcomes.
plus text messaging until birth) or to routine dietary advice; and to daily CONCLUSION: Although dietary education and or probiotics did not
capsules containing either (Lactobacillus rhamnosus GG and Bifido- alter rates of excessive gestational weight gain or birthweight in this
bacterium lactis BB12, minimum 6.5
109 colony forming units), or multiethnic, high-deprivation population of pregnant women with obesity,
placebo, until birth. Analysis was by intention to treat with adjustment for dietary education was associated with a modest reduction in total weight
maternal baseline body mass index. Infant outcomes were additionally gain with potential future benefit for the health of mothers and their
adjusted for ethnicity, sex, and gestational age at birth. offspring if sustained.
RESULTS: In total, 230 women were recruited between April 2015 and
June 2017 (dietary intervention N ¼ 116 vs routine dietary advice N ¼ Key words: community health worker, gestational weight gain, pro-
114; probiotics N ¼ 115 vs placebo N ¼ 115). Baseline characteristics biotics, text messaging

O besity during pregnancy is a

concern for obstetricians globally,
particularly in populations with high
Economic Co-operation and Develop-
ment countries.2 In New Zealand, the
greatest rates of obesity are among Pa-
have similar characteristics to the South
Auckland population, with high rates of
obesity and similar health outcomes.7
rates of obesity.1 The United States is cific (69%) and Maori (50%). Of Obesity during pregnancy is a risk
rated first and New Zealand as third- concern, 12% of children in New Zea- factor for many maternal and infant
most obese among the Organization for land are obese, and obesity rates are complications, including gestational
greater in those living in areas of high diabetes mellitus (GDM) and pre-
deprivation.3 The Counties Manukau eclampsia, and increased fetal exposure
Cite this article as: Okesene-Gafa KAM, Li M, McKinlay Health region in South Auckland is to excessive nutrients, resulting in large-
CJD, et al. Effect of antenatal dietary interventions in home to an ethnically diverse population for-gestational age (LGA) infants.8-11 A
maternal obesity on pregnancy weight-gain and birth- with high rates of obesity, where recent review highlighted maternal
weight: Healthy Mums and Babies (HUMBA) randomized approximately 70% of women giving obesity as a major determinant of health
trial. Am J Obstet Gynecol 2019.
birth reside in areas of high deprivation.4 during childhood and later adult life,
0002-9378/$36.00 Poor living conditions, overcrowding, increasing risks of noncommunicable
ª 2019 Elsevier Inc. All rights reserved. and poor nutrition further contribute to diseases12 and potentially contributing
https://doi.org/10.1016/j.ajog.2019.03.003
adverse health outcomes of women to the enormous obesity-related health
living in the region.4-6 Native Hawaiians costs.13 Excessive gestational weight gain
and Pacific Islanders in the United States (GWG) is more common in women with

MONTH 2019 American Journal of Obstetrics & Gynecology 1.e1

Original Research OBSTETRICS ajog.org

As few previous intervention studies

AJOG at a Glance have been conducted in multiethnic
Why was the study conducted? populations with obesity,32 the Healthy
To test whether dietary education and or probiotic capsules (Lactobacillus Mums and Babies (HUMBA) trial was
rhamnosus GG and Bifidobacterium lactis BB-12) could reduce excessive gesta- designed to determine whether a tailored
tional weight gain and birthweight in a multiethnic New Zealand population with dietary intervention (dietary education
obesity. [including goals] provided by commu-
nity health workers and complemented
Key findings by text messaging),23 and or probiotic
Dietary education and or probiotics did not reduce the proportion of women with capsules, could reduce excessive GWG
excessive gestational weight gain or birthweight, but dietary intervention resulted and birthweight in pregnant women
in a 1.8-kg reduction in total pregnancy weight gain. with obesity in South Auckland, NZ. We
hypothesized that the HUMBA trial in-
What does this add to what is known? terventions would reduce excessive
Our findings are consistent with meta-analyses that showed 0.7 to 1.4kg GWG and birthweight.33
reduction in total pregnancy weight gain with dietary interventions, confirming
that dietary education effects are generalizable to high-deprivation, multiethnic Materials and Methods
populations with obesity. Our findings add to the limited literature on probiotic Trial design and setting
treatment and pregnancy outcome. We also confirmed the feasibility of under- This was a single-center, 2
2 factorial
taking a randomized trial of dietary intervention in this setting. randomized controlled demonstration
trial34 in the Counties Manukau
Health Region of South Auckland, NZ.
obesity and has similar consequences for health including glucose homeostasis26 Ethics approval was obtained from the
mothers and their offspring as maternal in products containing predominantly Southern Health and Disability ethics
obesity.14-16 Lactobacillus and Bifidobacteria was re- committee, NZ (14/STH/205). The
Dietary and physical activity in- ported in a recent meta-analysis in HUMBA Trial was registered with the
terventions during pregnancy can reduce pregnant women from European coun- Australian NZ Clinical Trials Registry
maternal GWG and improve maternal tries.27 In addition, Lactobacillus rham- (ACTRN12615000400561). As the trial
and infant outcomes and are therefore of nosus in milk products has been protocol has been published,33 only brief
relevance to obstetricians.17-19 Long- associated with reduced severe pre- details are provided here.
term health benefits for mothers and eclampsia in an observational study
children also are reported.20 However, (adjusted odds ratio, 0.79; 95% confi- Participants
few interventions have been undertaken dence interval [CI], 0.66e0.96)28 and in Women with a singleton pregnancy at
in low socioeconomic settings, in which capsule form reduced postnatal depres- 12þ0 to 17þ6 weeks of gestation and
more challenges are encountered.21 sion (effect size, 1.2; 95% CI, 2.3 body mass index (BMI) 30 kg/m2 who
Despite challenges, dietary in- to 0.1) Edinburgh Postnatal Depres- provided informed written consent were
terventions delivered by community sion Score and reduced anxiety (effect eligible. Exclusion criteria were preex-
health workers offer a potential solution size, 1.0; 95% CI, 1.9, to 0.2).29 The isting diabetes or hemoglobin A1c 50
and are more affordable in a constrained most compelling metabolic benefits in mmol/mol,35 known congenital abnor-
healthcare environment than dietary in- pregnancy were reported in a Finnish mality, taking capsules or supplements
terventions provided by dietitians. study of 256 women randomized to di- containing probiotics, previous bariatric
Community health workers, providing a etary counselling supplemented with surgery, severe hyperemesis, and medi-
culturally designed diabetes intervention probiotics (Lactobacillus rhamnosus GG cations or medical conditions that alter
in nonpregnant populations in Amer- and Bifidobacterium lactis BB12) or pla- glucose metabolism.
ican Samoa, resulted in improved dia- cebo. There was a 64% reduction in
betes control. In addition, modern GDM in the probiotic compared with Randomization and concealment of
delivery of text messaging can penetrate placebo group but no difference in GWG allocation
most communities22,23 and has assisted or birthweight.30 In contrast, a recent Eligible women were allocated randomly
in reducing weight in nonpregnant randomized trial in 411 overweight and by the research midwife using a
populations.24 obese predominantly European preg- web-based randomization program
Other potential interventions include nant women did not find that probiotic (http://randomize.net) using random
use of probiotics (naturally occurring capsules reduced GDM (18.4% probiotic permuted blocks of 4e8 participants,
micro-organisms that, when ingested in arm vs 12.3% placebo, P ¼ .10), but stratified by BMI (30 to <35 or 35 kg/
adequate amounts, may confer health probiotic treatment was associated with m2), to dietary intervention and pro-
benefits to the host).25 The potential reduced excessive GWG (32% probiotic biotic or placebo capsules or routine
positive effect of probiotics on metabolic vs 46% placebo, P ¼ .01).31 dietary advice and probiotic or placebo

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ajog.org OBSTETRICS Original Research

capsules. Christian Hansen (Chr. Han- pregnant women”40 and “Healthy Compliance with capsules was defined
sen A/S, Horsholm, Denmark) provided weight-gain in pregnancy,”41,42 with no as taking probiotic or placebo capsules
identically packaged canisters containing dietary input from community health >75% of the time and was assessed by
either probiotic or placebo capsules. workers or text messages. participant verbal feedback at 28 weeks,
AnQual Laboratories (School of Phar- Women allocated to probiotics 36 weeks and post-birth. Compliance
macy, University of Auckland) labeled received capsules containing Lactoba- with the dietary intervention was
the canisters using a preallocated cillus rhamnosus GG and Bifidobacterium defined as completing 3 or 4 dietary
random list that was password pro- lactis BB12 (minimum dose 6.5
109 intervention visits with the community
tected.33 Participants, researchers, and colony forming units; www.chr-hansen. health worker.
data analysts were blinded to probiotic com). Women in the placebo group Within 72 hours of birth, a member of
and placebo allocation. Participants in received identical capsules containing the research team collected outcome
the dietary intervention could not be microcrystalline cellulose and dextrose data including last recorded weight
blinded but researchers collecting and anhydrate. Women were instructed to before birth; pre-labor blood pressure
analyzing outcome data were unaware of take 1 capsule (probiotic or placebo) daily and proteinuria; any illnesses, hospital
the dietary treatment allocation. until birth. All participants continued admissions or antibiotic use since the last
routine antenatal care. HUMBA visit; feedback about HUMBA
Interventions capsules and compliance; and all labor
Women allocated to the dietary inter- Assessments and birth outcomes. Neonatal length,
vention received a HUMBA handbook At recruitment (120-176 weeks), a head, chest, waist, and left mid-arm
with information about healthy nutri- research midwife took detailed de- circumferences and skin-fold thick-
tious foods, recipes, unhealthy drinks, mographic, medical, and obstetric his- nesses (subscapular, triceps, and supra-
managing cravings, and ways to be more tory. Physical measurements included iliac to the nearest 0.2 mm) were recor-
physically active. In addition, they blood pressure, height, weight, waist, ded.33 Whole-body fat and lean mass
received 4 home-based education ses- and arm circumference obtained using were measured by air-displacement
sions by a community health worker standard techniques.33 Hemoglobin A1c plethysmography according to the
with an Auckland University of Tech- and lipid concentrations were measured manufacturer’s instructions (Pea Pod;
nology Certificate of Pacific Nutrition36 with the cobas b 101 point-of-care sys- COSMED USA, Concord, CA) using
and trained in Healthy Conversa- tem (Roche Diagnostics International reference data of Fomon et al.48
tions.37,38 This included behavior change Ltd, Risch-Rotkreuz, Switzerland). The
techniques to promote healthy eating women completed standardized ques- Outcomes
and setting SMARTER goals (specific, tionnaires including the NZ Food The primary maternal outcome was the
measurable, action-oriented, realistic, Frequency-Short Form,43 NZ Physical proportion of women with excessive
timed, evaluated, and reviewed).39 Dur- Activity-Short Form,44 and 3 psycho- GWG defined as mean weekly weight
ing subsequent intervention visits, logical questionnaires (State Trait Anxi- gain >0.27 kg between recruitment and
community health workers plotted the ety Index Short-Form,45 Short Form 36 weeks’ gestation (or closest weight),
woman’s weight on a personal pregnancy Health Survey,46 and Edinburgh Post- adjusted for baseline BMI.49-51 The pri-
weight-gain chart33 and provided feed- natal Depression Scale47). mary infant outcome was birthweight
back and positive reinforcement for At 26e28 weeks’ gestation, partici- adjusted for gestation, infant sex,
goals achieved. A dietitian developed an pants underwent a 75-g OGTT with maternal baseline BMI, and self-
operation manual and provided over- measurement of fasting, 1- and 2-hour reported ethnicity. This outcome was
sight. Dietary intervention visits were glucose concentrations, and were chosen as shifts in birthweight have po-
aimed to be completed before the 26e28 referred to the diabetes in pregnancy tential to influence long-term health,
weeks’ HUMBA study 75-g oral glucose service if they met the NZ Study of including obesity.52
tolerance test (OGTT). Diabetes diagnostic criteria (fasting 5.5 Secondary maternal outcomes
Women in the dietary intervention also and 2 hour 9.0 mmol/L).35 included total maternal GWG adjusted
received motivational text messages 3 At 28 weeks’ gestation, obstetric his- for gestation (last pregnancy weight
times weekly from randomization until tory and anthropometric measure- minus weight at recruitment), OGTT,
birth. Content of the messages was ments were obtained by the research and hemoglobin A1c results at 28 and 36
designed to complement dietary educa- midwife, and women completed the NZ weeks, GDM by International and New
tion with some worded as if from the baby Food Frequency-Short Form43 and NZ Zealand Study of Diabetes criteria,
to the mother, eg, “Mum, remember to Physical Activity-Short Form ques- pregnancy-induced hypertension,53
read food labels.” Women could elect to tionnaires.44 At 36 weeks’ obstetric 54 45
depression, anxiety, and mode of
stop receiving texts at any time. history and anthropometric measure- birth.
Women allocated to routine dietary ments were obtained and women Infant secondary outcomes included
advice received the NZ Ministry of repeated the 3 psychological question- neonatal anthropometry, body compo-
Health pamphlets “Eating for healthy naires.45-47 sition, gestation at birth, rate of LGA

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Original Research OBSTETRICS ajog.org

(birthweight >90th centile) and small

FIGURE 1
for gestational age (birthweight <10th
Consort flow chart for the HUMBA trial
centile), admission to neonatal intensive
care unit (NICU), and composite
A
neonatal morbidity (refer to HUMBA
Screened for eligibility (n=482)
Protocol).33
Eligible but didn't consent (n=225)
Sample size and statistical analysis Too busy (n=68)
Weight is not a problem to the woman (n=2)

Enrolllment
We estimated that a total sample size of Do not want to answer (n=11)
220 women would provide at least 80% Unable to contact (n=101)
Childcare issues (n=5)
power to detect a 25% reduction in Other (n=38)
excessive GWG from 80%55 to 60% with Found to be ineligible (n=27)
BMI<30 (n=6)
either intervention, and 100 infants in Gestational age > 18 weeks (n=5)
each main intervention group (allowing Miscarriage/TOP before recruitment (n=4)
for 10% loss to follow-up) could detect a Other (n=12)

227-g difference in birth weight,

Consented and Randomised (n = 230)
assuming a mean (standard deviation
[SD]) birthweight of 3638 (521) g.56 A 2- Allocation
sided alpha level of <0.025 was specified
Dietary intervention arms

Allocated to Dietary interventions Allocated to Routine dietary advice

for the co-primary outcomes (Bonfer- (n=116) (n=114)
roni adjustment) and <0.05 for the
Analysis
secondary outcomes.
Analyses were performed with SAS Maternal primary outcome: Maternal primary outcome:
Evaluated for ITT analysis (n=107) Evaluated for ITT analysis (n=110)
9.4 (SAS Institute Inc, Cary, NC) by Not evaluated for ITT analysis (n=9) Not evaluated for ITT analysis (n=4)
intention-to-treat. Binary endpoints ♦ withdrew from study (n=3) ♦ missing outcome data (n=4)
were analyzed using modified Poisson ♦ missing outcome data (n=6)

regression models57 to estimate relative Neonatal primary outcome: Neonatal primary outcome:
risks for each of the interventions (di- Evaluated for ITT analysis (n=111) Evaluated for ITT analysis (n=111)
Not evaluated for ITT analysis (n=5) Not evaluated for ITT analysis (n=3)
etary intervention and probiotics). ♦ withdrew from study (n=3) ♦ fetal death/termination (n=3 )
Continuous outcomes were calculated ♦ missing outcome data (n=1)
♦ fetal death (n=1)
using generalized linear models to es-
timate any changes in outcomes with
B
the interventions (dietary intervention
Consented and Randomised (n = 230)
and probiotics) compared with their
respective control groups. Primary an- Allocation
Probiotics and Placebo arms

alyses reported marginal effects for each

Allocated to Probiotic capsules Allocated to Placebo capsules
randomized exposure, with adjustment (n=115) (n=115)
for cointervention and prespecified
Analysis
covariates, as defined previously. In-
teractions between the main effects Maternal primary outcome: Maternal primary outcome:
were tested for primary outcomes, Evaluated for ITT analysis (n=108) Evaluated for ITT analysis (n=109)
Not evaluated for ITT analysis (n=7) Not evaluated for ITT analysis (n=6)
although the trial was only powered for ♦ withdrew from study (n=3) ♦ missing outcome data (n=6)
the main effects. Sensitivity analysis for ♦ missing outcome data (n=4)
the primary outcomes was performed Neonatal primary outcome: Neonatal primary outcome:
in women who were compliant with the Evaluated for ITT analysis (n=110) Evaluated for ITT analysis (n=112)
Not evaluated for ITT analysis (n=5) Not evaluated for ITT analysis (n=3)
trial interventions. ♦ withdrew from study (n=3) ♦ missing outcome data (n=1)
♦ fetal death/termination (n=2) ♦ fetal death/termination (n=2 )
Results
Between April 2015 and June 2017, 482 BMI, body mass index; HUMBRA, Healthy Mums and Babies; ITT, intention to treat; TOP, termination of pregnancy.
women were referred of whom 230 were Okesene-Gafa et al. Effect of antenatal dietary interventions in maternal obesity on pregnancy weight-gain and birthweight:
Healthy Mums and Babies (HUMBA) randomized trial. Am J Obstet Gynecol 2019.
enrolled (Figure 1). Key demographic
characteristics were similar between
those who did and did not agree to kg/m2. More than 60% resided in areas ethnic distribution of participants was
participate (Table 1). Among partici- with the highest national deprivation similar to the local birthing population.4
pants, the mean age (SD) was 28.8 (5.7) quintile (20% expected) and one third Baseline characteristics were balanced
years and mean BMI (SD) was 38.8 (6.1) were not born in New Zealand. The between groups, for both randomization

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ajog.org OBSTETRICS Original Research

both randomization factors, including

TABLE 1
gestational age at birth, anthropometric
Comparison between women who consented or declined to participate
and body composition outcomes, pre-
Variables Consented N ¼ 230 Declined N ¼ 225 P value term birth, admission to the NICU, and
Maternal age, y 28.8 (5.7) 27.9 (5.7) .10 composite morbidity (Table 4).
Weight, kg 107.1 (17.9) 105.9 (18.5) .51 Secondary analysis
Height, cm 166.2 (6.2) 166.6 (5.6) .42 In sensitivity analysis, exclusion of
BMI, kg/m 2
38.8 (6.1) 38.0 (5.7) .22 women who were noncompliant with
a the dietary intervention did not alter the
Ethnicity .60
results for the primary outcomes for this
New Zealand Maori 52 (22.6) 33 (14.7) factor. However, among women who
Cook Island Maori 28 (12.2) 18 (8.0) were compliant with capsules, those who
Samoan 46 (20.0) 74 (32.9) received probiotics were more likely to
have excessive GWG than those who
Tongan 27 (11.7) 53 (23.6)
received placebo (72/87 [82.8%] vs 64/
Other Pacific Island 13 (5.7) 4 (1.8) 91 [70.3%], adjusted RR, 1.18; 95% CI,
European 42 (18.3) 27 (12.0) 1.00e1.39, P ¼ .04) and although not
Indian 13 (5.7) 9 (4.0) significantly different, birthweight was
greater (3701 [583] vs 3540 g [657] g,
Other 9 (3.9) 7 (3.1)
adjusted MD, 108; 95% CI, e20 to 235,
Data are presented as mean (standard deviation) or n (%).
P ¼ .10).
BMI, body mass index.
a
Prioritized ethnicity.
Okesene-Gafa et al. Effect of antenatal dietary interventions in maternal obesity on pregnancy weight-gain and
Discussion
birthweight: Healthy Mums and Babies (HUMBA) randomized trial. Am J Obstet Gynecol 2019. Neither the tailored dietary interven-
tion nor probiotics had a significant
effect on the proportion of women with
factors (dietary intervention N ¼ 116 vs 97 g; probiotic vs placebo: mean [SD] excessive GWG or birthweight in this
routine dietary advice N ¼ 114; and 3685 [565] g and 3504 [672] g, adjusted multiethnic population of pregnant
probiotics N ¼ 115 vs placebo N ¼ 115) MD, 107; 95% CI, e14 to 228 g) women with obesity, although the di-
(Table 2). Eighty-one percent of women (Table 4). There was no significant etary intervention was associated with
were compliant with dietary in- interaction between randomization fac- less total GWG than routine dietary
terventions (94/116), and 76% met the tors for the primary maternal (P ¼ .89) advice. The interventions did not affect
criteria for compliance with probiotic and neonatal (P ¼ .48) outcomes. other maternal secondary outcomes
capsules (87/115). No serious adverse including glucose metabolism, risk of
events were attributed to trial in- Secondary Outcomes developing GDM, pregnancy-induced
terventions by the Data Safety Moni- Women who received the dietary inter- hypertension, caesarean delivery, or
toring Committee. vention compared with routine dietary psychological measures of well-being.
advice had a marginally significant Similarly, neither intervention altered
Primary outcomes reduction in total GWG (mean [SD] 9.7 neonatal anthropometry, body compo-
There was no significant difference be- [6.6] vs 11.4 [6.3] kg; adjusted MD, sition, or neonatal morbidity. In the
tween intervention groups for the pri- e1.76; 95% CI, e3.55 to 0.03, P ¼ .05). secondary analysis of women compliant
mary maternal outcome of excessive There were no significant differences in with capsules, probiotic treatment was
GWG, for either randomization factor any of the other secondary maternal associated with an increase in excessive
(dietary intervention vs routine advice outcomes between intervention groups GWG.
[73.8% vs 81.8%, adjusted risk ratio for either randomization factor, Our finding of a 1.76-kg reduction in
{RR}, 0.92; 95% CI, 0.80e1.05]; pro- including glucose metabolism, GDM, total GWG following dietary interven-
biotic vs placebo [82.4% vs 73.4%, hemoglobin A1c levels at 28 and 36 tion is similar to that in 2 recent meta-
adjusted RR, 1.14; 95% CI, 0.99e1.31]) weeks, State Trait Anxiety Index Short- analyses in women of any BMI. One
(Table 3). There was no significant dif- Form and Edinburgh Postnatal Depres- showed a 1.42-kg (95% CI, 0.95e1.89
ference between intervention groups for sion Scale scores at 36 weeks, pregnancy- kg; I2 ¼ 80%) reduction in GWG17 and
the primary neonatal outcome of birth- induced hypertension, and mode of the other, which analyzed individual
weight, for either randomization factor birth (Table 3). participant data,32 a e0.70-kg (95% CI,
(dietary vs routine: mean [SD] 3575 There was no significant difference e0.92 to e0.48 kg, I2 ¼ 14.1%)
[609] g and 3612 [646] g, adjusted mean between intervention groups for any of reduction in GWG. In a subgroup of
difference [MD], e24; 95% CI, e146 to the neonatal secondary outcomes, for obese and overweight women, dietary

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Original Research OBSTETRICS ajog.org

TABLE 2
Characteristics of trial participants at recruitment
Dietary intervention Routine dietary advice Probiotic Placebo
Characteristics N ¼ 116 N ¼ 114 N ¼ 115 N ¼ 115
Age, y 29.8 (5.7) 27.8 (5.5) 28.9 (5.7) 28.6 (5.7)
Weight, kg 109.0 (18.9) 105.3 (18.3) 108.0 (20.0) 106.4 (17.3)
Height, cm 166.6 (5.8) 166.5 (6.0) 166.4 (6.1) 166.8 (5.6)
BMI, kg/m2 39.2 (6.2) 37.9 (5.9) 38.9 (6.5) 38.2 (5.7)
2
BMI category, kg/m , n (%)
30e34.9 35 (30.2) 38 (33.3) 36 (31.3) 37 (32.2)
>35.0 81 (69.8) 76 (66.7) 79 (68.7) 78 (67.8)
Ethnicity, n (%)
New Zealand Maori 25 (21.6) 27 (23.7) 25 (21.7) 27 (23.5)
Cook Island Maori 16 (13.8) 12 (10.5) 15 (13.0) 13 (11.3)
Samoan 23 (19.8) 23 (20.2) 24 (20.9) 22 (19.1)
Tongan 14 (12.1) 13 (11.4) 13 (11.3) 14 (12.2)
Other Pacific Island 8 (6.9) 5 (4.4) 6 (5.2) 7 (6.1)
Caucasian 21 (18.1) 21 (18.4) 18 (15.7) 24 (20.9)
Indian 6 (5.2) 7 (6.1) 9 (7.8) 4 (3.5)
Other 3 (2.6) 6 (5.3) 5 (4.4) 4 (3.5)
Parity, n (%)
0 30 (25.9) 43 (37.7) 35 (30.4) 38 (33.0)
1e3 70 (60.3) 62 (54.4) 69 (60.0) 63 (54.8)
4 16 (13.8) 9 (7.9) 11 (9.6) 14 (12.2)
Didn’t complete high school, n (%) 35 (30.2) 34 (29.8) 35 (30.4) 34 (29.6)
Paid employment, n (%) 55 (47.4) 60 (52.6) 60 (52.2) 55 (47.8)
Highest deprivation quintile, n (%) 72 (62.1) 76 (66.7) 79 (68.7) 69 (60.0)
Married/civil union, n (%) 65 (56.0) 59 (51.8) 69 (60.0) 55 (47.8)
Current smoker, n (%) 17 (14.7) 15 (13.2) 15 (13.0) 17 (14.8)
Gestation at recruitment, wk, n (%) 15.3 (1.9) 14.9 (1.7) 15.2 (1.8) 15.1 (1.8)
EPDS e proportion abnormal n, (%) 11/116 (9.5) 20/113 (17.7) 14/115 (12.2) 17/114 (14.9)
STAI-SF e proportion abnormal, n (%) 3/116 (2.6) 5/113 (4.4) 2/115 (1.7) 6/114 (5.3)
Family history, n (%)
Family history of chronic hypertensiona 51 (44.0) 49 (43.0) 49 (42.6) 51 (44.4)
a
Family history of diabetes 45 (38.8) 48 (42.1) 51 (44.4) 42 (36.5)
Medical history, n (%)
Chronic hypertension 13 (11.2) 9 (7.9) 10 (8.7) 12 (10.4)
Depression 13 (11.2) 17 (14.9) 10 (8.7) 20 (17.4)
Asthma 13 (11.2) 15 (13.2) 18 (15.7) 10 (8.7)
Okesene-Gafa et al. Effect of antenatal dietary interventions in maternal obesity on pregnancy weight-gain and birthweight: Healthy Mums and Babies (HUMBA) randomized trial. Am
J Obstet Gynecol 2019. (continued)

intervention was associated with a 2.1- with our trial, no significant effect of reported.17,32 In line with our trial, the
kg (95% CI, e3.46 to e0.75; I2 ¼ dietary and physical activity in- individual participant data meta-
88%) reduction in GWG.17 Consistent terventions on birthweight have been analysis reported that dietary and or

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ajog.org OBSTETRICS Original Research

TABLE 2
Characteristics of trial participants at recruitment (continued)
Dietary intervention Routine dietary advice Probiotic Placebo
Characteristics N ¼ 116 N ¼ 114 N ¼ 115 N ¼ 115
Obstetric history,b n (%) N ¼ 85 N ¼ 71 N ¼ 80 N ¼ 76
Cesarean delivery 23 (27.1) 21 (29.6) 25 (31.3) 19 (25.0)
Gestational diabetes mellitus 4 (4.7) 2 (2.8) 3 (3.8) 3 (3.9)
c
Hypertension in pregnancy 16 (18.8) 18 (25.4) 16 (20.0) 18 (23.7)
Preterm birth 12 (14.1) 8 (11.3) 10 (12.5) 10 (13.2)
Stillbirth/neonatal death 6 (7.1) 5 (7.0) 7 (8.8) 4 (5.3)
Data are mean (standard deviation) or n (%).
BMI, body mass index; EPDS, Edinburgh Postnatal Depression Scale; STAI-SF, State Trait Anxiety Inventory Score-Short Form.
a
History of mother, father, or sibling with condition; b Nulliparous excluded; c Defined as previous history of gestational hypertension or pregnancy-induced hypertension or preeclampsia.
Okesene-Gafa et al. Effect of antenatal dietary interventions in maternal obesity on pregnancy weight-gain and birthweight: Healthy Mums and Babies (HUMBA) randomized trial. Am
J Obstet Gynecol 2019.

physical activity interventions did not hypertension28 and depression or anxi- the feasibility of carrying out a complex
alter small-for-gestational-age or LGA ety29; however, we were unable to trial in a population that has significant
infants, stillbirth, NICU admission, or demonstrate this in our trial. barriers to engaging with antenatal
composite maternal and neonatal out- Our finding that excessive GWG was care.64 Importantly, women who
comes.32 In contrast to the HUMBA more common in mothers compliant participated were similar to those who
Trial, both dietary and physical activity with probiotics should be interpreted chose not to participate, suggesting our
interventions reduced caesarean de- with caution, as our assessment of results are broadly generalizable to the
livery (RR, 0.91; 95% CI, 0.83e0.99) compliance (participant self-report) was population of interest. In contrast to
whereas dietary interventions reduced suboptimal. However, these findings are previous literature, which has reported
rates of preterm birth (RR, 0.28; 95% consistent with those from a meta- low rates of participation of ethnic mi-
CI, 0.08e0.96).32 These differences may analysis of randomized trials60 that norities in pregnancy research,65 we
be due to the differences in participant showed that a probiotic frequently used achieved high participation among
characteristics, as the meta-analysis in humans (Lactobacillus acidophilus) Maori and Pacific women, with >90%
populations were more than 80% resulted in increased weight in lean primary outcome data collected.
white, 50% of high socioeconomic sta- nonpregnant adults (standardized MD, Success with providing the dietary
tus, and only 40% had obesity. 0.15; 95% CI, 0.05 to 0.25; p ¼ .005, I2 ¼ interventions was due to the ability of
Our findings for the probiotic inter- 42%). In contrast, the SPRING trial of community health workers to meet
vention contrast with a Finnish trial that probiotics in overweight and obese pre- women at their desired location and
used the same probiotics30 and another dominantly European women reported provide a culturally tailored interven-
trial using Lactobacillus rhamnosus58 that excessive GWG was less common in tion. Having community health workers
that reported reduced rates of GDM women who received probiotics (32.5% with similar ethnicity as the majority of
with probiotics. The recently reported vs 46%, P ¼ .01).31 the participants, as recommended by a
Study of Probiotics IN prevention of The modest reduction in total GWG in previous multicenter report,66 may have
Gestational diabetes study,31 which used pregnancy with the dietary intervention, assisted with participant engagement.
the same probiotics as our trial, also did if sustained, could have longer-term Our assessment of compliance with
not observe a reduction in GDM (18.3% health benefits, as increases in weight as dietary intervention as number of visits
probiotic and 12.3% placebo, P ¼ .10). little as 1.5%e2.5% or 1 BMI unit (2.7 kg) attended was pragmatic but is an insuf-
Consistent with the findings from our between pregnancies have been associated ficient measure of adherence to dietary
study, a recent meta-analysis investi- with increased GDM, preeclampsia, and intervention. Similarly, compliance with
gating preterm birth prevention in LGA in the next pregnancy.61-63 pills, relied largely on self-report, and is
healthy pregnant women (n ¼ 4098) This was the first trial of a tailored less reliable than pill counting.
showed that probiotics did not affect dietary intervention and/or probiotics
birthweight, LGA, risk of GDM, or pre- performed in a multiethnic population Conclusion
term birth.59 Previous studies have of predominantly Pacific and Maori Neither a tailored dietary intervention
reported that women receiving pro- pregnant women with obesity living in nor probiotics altered rates of excessive
biotics have less pregnancy-induced high deprivation. We have demonstrated GWG or birthweight in this multiethnic,

MONTH 2019 American Journal of Obstetrics & Gynecology 1.e7

 Original Research
1.e8 American Journal of Obstetrics & Gynecology MONTH 2019

TABLE 3
Maternal primary and secondary outcomes
Dietary intervention Routine dietary Adjusted treatment Probiotic Placebo Adjusted treatment effect
Outcomes N ¼ 116 advice N ¼ 114 effect RR or MD (95% CI) P value N ¼ 115 N ¼ 115 RR or MD (95% CI) P value
Primary outcome
Excessive weight gain 79/107 90/110 0.92 (0.80e1.05) .22 89/108 80/109 1.14 (0.99e1.31) .08
(>0.27 kg/wk)a (73.8) (81.8) (82.4) (73.4)
Secondary outcomes
Weight change baseline to 9.7 (6.6) 11.4 (6.3) e1.76 (e3.55, 0.03) .05 11.0 (6.5) 10.1 (6.5) 0.86 (e0.95, 2.67) .35
36 wkb N ¼ 100 N ¼ 101 N ¼ 100 N ¼ 101

OBSTETRICS
GDM (IADPSG criteria)a n/N(%) 30/96 (31.3) 23/100 (23.0) 1.31 (0.83e2.09) .25 28/105 (26.7) 25/91 (27.5%) 0.94 (0.59e1.49) .80
Fasting glucose OGTT, mmol/L 4.6 (0.5) 4.6 (0.5) 0.00 (e0.14, 0.14) .94 4.6 (0.5) 4.7 (0.5) e0.06 (e0.20, 0.08) .37
N ¼ 96 N ¼ 100 N ¼ 105 N ¼ 91
1-h glucose OGTT, mmol/L 8.1 (1.8) 8.1 (1.6) 0.05 (e0.52, 0.62) .86 8.0 (1.6) 8.1 (1.8) e0.10 (e0.67, 0.47) .72
N ¼ 67 N ¼ 72 N ¼ 75 N ¼ 64
2-h glucose OGTT, mmol/L 6.3 (1.4) 6.2 (1.2) 0.04 (e0.33, 0.41) .83 6.3 (1.3) 6.2 (1.3) 0.04 (e0.33, 0.41) .84
N ¼ 96 N ¼ 99 N ¼ 105 N ¼ 90
HbA1c 36 wka 38.1 (5.0) 37.0 (4.0) 0.93 (e0.48, 2.33) .19 37.9 (4.6) 37.3 (4.5) 0.56 (e0.83, 1.96) .43
N ¼ 81 N ¼ 79 N ¼ 84 N ¼ 76
EPDS 36 wk 9/83 (10.8) 7/81 (8.6) 1.25 (0.49e3.21) .64 8/88 (9.1) 8/76 (10.5) 0.86 (0.34e2.19) .76
e proportion abnormal, n/N (%)
STAI-SF score 36 wk 7/85 (8.2) 3/79 (3.8) 2.17 (0.58e8.10) .25 6/87 (6.9) 4/77 (5.2) 1.33 (0.39e4.53) .65
e proportion abnormal, n/N (%)
Pregnancy-induced 8/110 (7.3) 10/111 (9.0) 0.78 (0.32e1.90) .58 11/108 (10.2) 7/113 (6.2) 1.61 (0.64e4.09) .31
hypertensiona
Mode of birth, n (%) N ¼ 112 N ¼ 114 N ¼ 112 N ¼ 114
a
Unassisted vaginal birth 67 (59.8) 72 (63.2) 0.91 (0.53e1.56) .72 64 (57.1) 75 (65.8) 0.71 (0.41e1.21) .21
Operative vaginal birtha 6 (5.4) 5 (4.4) 1.21 (0.36e4.15) .76 7 (6.3) 4 (3.5) 1.82 (0.52e6.42) .35
Total cesarean deliveriesa 39 (34.8) 36 (31.6) 1.11 (0.63e1.95) .71 40 (35.7) 35 (30.7) 1.23 (0.70e2.15) .47
Emergency cesarean 14 (12.5) 19 (16.7) 0.71 (0.34e1.51) .37 21 (18.8) 12 (10.5) 1.97 (0.92e4.23) .08
deliveriesa
Stillbirth 1 (0.9) 3 (2.6) 0.33 (0.03e3.25) .34 2 (1.8) 2 (1.8) 1.02 (0.14e7.36) .99
Data are mean (standard deviation) or n (%) as marked.
Interaction test for primary maternal outcome P ¼ .89.
BMI, body mass index; CI, confidence interval; EPDS, Edinburgh Postnatal Depression Scale; GDM, gestational diabetes mellitus; HbA1c, hemoglobin A1c; IADPSG, International Association of Diabetes and Pregnancy Trial Groups; MD, Mean difference; OGTT, oral

ajog.org
glucose tolerance test; RR, relative risk; STAI-SF, State Trait Anxiety Inventory Score-Short Form.
a
Adjusted for maternal baseline BMI; b Adjusted for gestational age at 36 weeks.
Okesene-Gafa et al. Effect of antenatal dietary interventions in maternal obesity on pregnancy weight-gain and birthweight: Healthy Mums and Babies (HUMBA) randomized trial. Am J Obstet Gynecol 2019.
 ajog.org
TABLE 4
Neonatal primary and secondary outcomes of liveborn infants
Routine
Dietary dietary Adjusted treatment effect* Adjusted treatment effect*
intervention advice RR or MD Probiotic Placebo RR or MD
Outcomes N ¼ 116 N ¼ 114 (95% CI) P value N ¼ 115 N ¼ 115 (95% CI) P value
Primary outcome
Birthweight, ga 3575 (609) 3612 (646) e24 (e146, 97) .69 3685 (565) 3504 (672) 107 (e14, 228) .08
N ¼ 111 N ¼ 111 N ¼ 110 N ¼ 112
Secondary outcomes
Gestation, wk 39.1 (1.9) 39.1 (2.1) e0.04 (e0.58, 0.49) .87 39.3 (1.7) 38.9 (2.3) 0.48 (e0.05, 1.01) .08
N ¼ 111 N ¼ 111 N ¼ 110 N ¼ 112
Gestation <37 wk, n/N (%) 10/111 (9.0) 4/111 (3.6) 2.59 (0.85e7.90) .10 5/110 (4.6) 9/112 (8.0) 0.58 (0.20e1.65) .31
NICU admission, n/N (%) 13/110 (11.8) 7/110 (6.4) 1.76 (0.72e4.31) .21 8/109 (7.3) 12/111 (10.8) 0.69 (0.29e1.62) .39
Composite morbidity, n/N (%) 17/111 (15.3) 13/111 (11.7) 1.24 (0.64e2.41) .52 12/110 (10.9) 18/112 (16.1) 0.69 (0.35e1.34) .27
Birth size measures N ¼ 111 N ¼ 111 N ¼ 110 N ¼ 112

Head circumference, cm 35.5 (1.6) 35.3 (2.1) 0.16 (e0.32, 0.64) .51 35.5 (1.6) 35.2 (2.1) 0.35 (e0.12, 0.83) .15
N ¼ 110 N ¼ 111 N ¼ 109 N ¼ 112
Length, cm 50.8 (2.8) 51.1 (3.4) e0.35 (e1.18, 0.48) .41 51.3 (2.9) 50.7 (3.3) 0.71 (e0.11, 1.53) .09
N ¼ 109 N ¼ 111 N ¼ 109 N ¼ 111
Chest circumference, cmb
MONTH 2019 American Journal of Obstetrics & Gynecology

34.7 (2.0) 34.9 (2.2) 0.12 (e0.38, 0.62) .65 35.0 (1.9) 34.6 (2.3) 0.24 (e0.25, 0.73) .34
N ¼ 92 N ¼ 92 N ¼ 95 N ¼ 89
Left arm circumference, cmb e0.20 (e0.58, 0.18)

OBSTETRICS
11.3 (1.3) 11.4 (1.4) 0.04 (e0.34, 0.43) .82 11.3 (1.5) 11.4 (1.2) .30
N ¼ 92 N ¼ 92 N ¼ 95 N ¼ 89
Abdominal circumference, cmb 33.1 (2.3) 33.6 (2.5) 0.00 (e0.60, 0.59) .99 33.5 (2.3) 33.1 (2.5) 0.20 (e0.39, 0.78) .51
N ¼ 92 N ¼ 92 N ¼ 95 N ¼ 89
Birth size z scores N ¼ 111 N ¼ 111 N ¼ 110 N ¼ 112
Birthweight 0.59 (0.97) 0.63 (1.04) e0.02 (e0.29, 0.24) .86 0.72 (0.97) 0.50 (1.04) 0.26 (e0.00, 0.52) .05

Original Research
Head circumference 1.15 (1.12) 1.08 (1.13) 0.10 (e0.19, 0.40) .50 1.14 (1.06) 1.09 (1.19) 0.11 (e0.19, 0.40) .48
Length 0.51 (1.09) 0.69 (1.22) e0.18 (e0.49, 0.14) .27 0.66 (1.16) 0.54 (1.15) 0.15 (e0.16, 0.46) .33
Birthweight centiles N ¼ 111 N ¼ 111 N ¼ 110 N ¼ 112
SGA <10th customized, n (%) 14 (12.6) 11 (9.9) P ¼ .81 8 (7.3) 17 (15.2) P ¼ .13
Okesene-Gafa et al. Effect of antenatal dietary interventions in maternal obesity on pregnancy weight-gain and birthweight: Healthy Mums and Babies (HUMBA) randomized trial. Am J Obstet Gynecol 2019. (continued)
1.e9
 Original Research
1.e10 American Journal of Obstetrics & Gynecology MONTH 2019

TABLE 4
Neonatal primary and secondary outcomes of liveborn infants (continued)
Routine
Dietary dietary Adjusted treatment effect* Adjusted treatment effect*
intervention advice RR or MD Probiotic Placebo RR or MD
Outcomes N ¼ 116 N ¼ 114 (95% CI) P value N ¼ 115 N ¼ 115 (95% CI) P value
AGA 10-90th customized, n (%) 84 (75.7) 86 (77.5) 90 (81.8) 80 (71.4)
LGA >90th customized, n (%) 13 (11.7) 14 (12.6) 12 (10.9) 15 (13.4)
SGA <10th WHO, n (%) 4 (3.6) 4 (3.6) .89 3 (2.7) 5 (4.5) .78

OBSTETRICS
AGA 10th-90th WHO, n (%) 79 (71.2) 82 (73.9) 81 (73.6) 80 (71.4)
LGA >90th WHO, n (%) 28 (25.2) 25 (22.5) 26 (23.6) 27 (24.1)
Whole-body composition (Pea Pod) b
N ¼ 49 N ¼ 61 N ¼ 57 N ¼ 53
Fat mass, kg b
0.40 (0.21) 0.43 (0.22) 0.00 (e0.08, 0.07) .93 0.40 (0.18) 0.44 (0.24) e0.07 (e0.14, 0.01) .09
b
Lean mass, kg 3.1 (0.39) 3.1 (0.47) 0.01 (e0.11, 0.13) .84 3.1 (0.43) 3.1 (0.43) 0.01 (e0.11, 0.12) .88
Fat mass adjusted for lean mass, kg e 0.00 (e0.08, 0.07) .90 e e e0.07 (e0.14, 0.01) .08
Skinfold measurements N ¼ 90 N ¼ 89 N ¼ 92 N ¼ 87
Subscapular, mm b
5.7 (1.3) 5.9 (1.4) e0.08 (e0.48, 0.31) .68 5.7 (1.3) 5.8 (1.4) e0.22 (e0.61, 0.17) .27
Triceps, mm b
6.3 (1.4) 6.4 (1.5) e0.02 (e0.44, 0.41) .94 6.3 (1.4) 6.4 (1.4) e0.13 (e0.55, 0.28) .53
Supra-iliac, mm b
5.7 (1.9) 5.9 (1.7) e0.03 (e0.57, 0.51) .90 6.0 (2.0) 5.7 (1.6) 0.11 (e0.42, 0.65) .68
Arm muscle area, cm2c 7.0 (1.8) 7.2 (1.9) e0.22 (e0.75, 0.31) .41 7.1 (2.0) 7.2 (1.6) 0.23 (e0.32, 0.78) .41
Data are n/N (%), mean (SD), or RR.
Composite morbidity includes birth trauma (fracture, brachial plexus injury, cephalohematoma, subgaleal hematoma), hypoxiceischemic encephalopathy, sepsis, respiratory distress requiring positive pressure support, and hypoglycemia requiring dextrose
treatment.
All analyses adjusted for maternal body mass index at pregnancy booking, maternal ethnicity, and infant sex.
Interaction test for primary neonatal outcome P ¼ .48.
AGA, appropriate for gestational age, birthweight >10th to < 90th centile; CI, confidence interval; LGA, large for gestational age, >90th centile; MD, mean difference; NICU, neonatal intensive care unit; RR, relative risk; SD, standard deviation; SGA, small for
gestational age, birthweight <10th centile; WHO, World Health Organization.
a
Birthweight additionally adjusted for gestation length; other measures of birth size and body composition additionally adjusted for; b crown-heel or; c acromion-radiale length.
Okesene-Gafa et al. Effect of antenatal dietary interventions in maternal obesity on pregnancy weight-gain and birthweight: Healthy Mums and Babies (HUMBA) randomized trial. Am J Obstet Gynecol 2019.

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ajog.org OBSTETRICS Original Research

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Acknowledgments
et al. The hyperglycemia and adverse pregnancy reduce weight: a systematic review.
We thank the women who participated in outcome study: associations of GDM and J Cardiovasc Nurs 2013;28:320–9.
HUMBA. We also thank research midwives: obesity with pregnancy outcomes. Diabetes 25. Food and Agriculture Organization of the
Cecile O’Driscoll, Sarah Va’afusuaga, Susan Care 2012;35:780–6. United Nations WHO. Joint FAO/WHO expert
Ross-Heard, Annette Hallaran, and pediatric 11. Van Lieshout RJ, Taylor VH, Boyle MH. consultation on evaluation of health and nutri-
nurse Megan McCowan; the HUMBA Commu- Pre-pregnancy and pregnancy obesity and tional properties of probiotics in food including
nity Health Workers: Eseta Nicholls, Kristine Day, neurodevelopmental outcomes in offspring: a powder milk with live lactic acid bacteria.
and Mele Fakaosilea; the HUMBA Dietitian: systematic review. Obes Rev 2011;12:e548–59. Cordoba, Argentina: FAO WHO; 2001:1–34.
Deirdre Nielsen; Project managers Shireen Chua 12. Godfrey KM, Reynolds RM, Prescott SL, 26. Nieuwdorp M, Gilijamse PW, Pai N,
and Noleen van Zyl; Dr Rebecca Pullon for sta- et al. Influence of maternal obesity on the long- Kaplan LM. Role of the microbiome in energy
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development of community health workers (AUT 13. Tremmel M, Gerdtham UG, Nilsson PM, 27. Zheng J, Feng Q, Zheng S, Xiao X. The effects
Certificate of Proficiency in Pacific Nutrition), and Saha S. economic burden of obesity: a sys- of probiotics supplementation on metabolic
assisting with nutritional resources and text tematic literature review. Int J Environ Res Public health in pregnant women: an evidence based
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Lucilla Poston for sharing nutritional resources 14. Kim SY, Sharma AJ, Sappenfield W, 28. Brantsaeter AL, Myhre R, Haugen M, et al.
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44. McLean G, Tobias MI. The New Zealand 57. Zou G. A modified Poisson regression This trial received financial and in-kind support from
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Spielberger State-Trait Anxiety Inventory (STAI). randomised controlled trial. Br J Nutr 2017;117: and New Zealand College of Obstetricians and Gynae-
Br J Clin Psychol 1992;31:301–6. 804–13. cologists); Nurture Foundation; and the Heart Foundation

1.e12 American Journal of Obstetrics & Gynecology MONTH 2019

ajog.org OBSTETRICS Original Research

of New Zealand. In-kind support: Roche Diagnostics In- in the writing of the report; and the decision to submit the The main findings were presented at the Perinatal
ternational Ltd provided the cobas b 101 point-of-care article for publication. Society of Australia and New Zealand Annual Scientific
system for measuring hemoglobin A1c and lipids and Universal Clinical trial number (UTN) U1111-1155- Congress, ANZ Viaduct Events Centre, Auckland, New
Christian Hansen (Chr. Hansen A/S, Horsholm, Denmark) 0409. Zealand, Mar. 25-28, 2018.
provided the probiotic/placebo capsules free of charge. Australian New Zealand Clinical Trials Registry num- Corresponding author: Karaponi Okesene-Gafa,
The funding sources had no involvement in the trial ber: ACTRN12615000400561 (http://www.ANZCTR.org. FRANZCOG. [email protected]
design; collection, analysis, and interpretation of the data; au/ACTRN12615000400561.aspx)

MONTH 2019 American Journal of Obstetrics & Gynecology 1.e13