Original Research
Pregnancy Exercise and Nutrition With
Smartphone Application Support
A Randomized Controlled Trial
Maria A. Kennelly, MRCPI, Kate Ainscough, MSc, Karen L. Lindsay, PhD, Elizabeth O’Sullivan,
Eileen R. Gibney, PhD, Mary McCarthy, PhD, Ricardo Segurado, PhD, Giuseppe DeVito, PhD,
Downloaded from http://journals.lww.com/greenjournal by BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC1y0abggQZXdtwnfKZBYtws= on 10/01/2021
Orla Maguire, PhD, Thomas Smith, PhD, Mensud Hatunic, MD,
and Fionnuala M. McAuliffe, MD, FRCOG
OBJECTIVE: To evaluate the effect of a healthy lifestyle
package (an antenatal behavior change intervention
supported by smartphone application technology) on
the incidence of gestational diabetes mellitus (GDM) in
overweight and obese women.
METHODS: Women with body mass indexes (BMIs) 25–
39.9 were enrolled into this randomized controlled trial.
The intervention consisted of specific dietary and exer-
cise advice that addressed behavior change supported by
a tailor-designed smartphone application. Women in the
control group received usual care. The primary outcome
was the incidence of GDM at 28–30 weeks of gestation.
To reduce GDM from 15% to 7.2%, we estimated that
From the UCD Perinatal Research Centre, Obstetrics and Gynaecology, School of
Medicine, the UCD Institute of Food and Health, UCD CSTAR, and the School
of Public Health, Physical & Sports Sciences, Health Sciences Centre, University
College Dublin, Dublin, the Department of Management & Marketing, Univer-
sity College Cork, Cork, and the Department of Endocrinology, St. Vincent’s
University Hospital, and the Department of Endocrinology, National Maternity
Hospital, Dublin, Ireland.
This trial was funded by the National Maternity Hospital medical fund. The
funding source did not have a role in the trial design or manuscript preparation.
Presented at the Society for Reproductive Investigation, March 15–18, 2017,
Orlando, Florida; and at the British Society for Maternal Fetal Medicine, March
30–31, 2017, Amsterdam, the Netherlands.
The authors thank the mothers of the National Maternity Hospital who partic-
ipated in the study.
Each author has indicated that he or she has met the journal’s requirements for
authorship.
Corresponding author: Fionnuala M. McAuliffe, FRCOG, FRCPI, Chair and
Professor of Obstetrics & Gynaecology, University College Dublin Head,
Women’s and Children’s Health, University College Dublin University College
Dublin, National Maternity Hospital, Holles Street, D2, Dublin, Ireland; email:
fionnuala.mcauliffe@ucd.ie.
Financial Disclosure
The authors did not report any potential conflicts of interest.
© 2018 by American College of Obstetricians and Gynecologists. Published by
Wolters Kluwer Health, Inc. All rights reserved.
ISSN: 0029-7844/18
818 VOL. 131, NO. 5, MAY 2018
Copyright Ó by American College of Obstetricians
and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
PhD,
506 women would be required to have 80% power to
detect this effect size at a significance of .05, that is,
253 in each group.
RESULTS: Between March 2013 and February 2016, 565
women were recruited with a mean BMI of 29.3 and
mean gestational age of 15.5 weeks. The incidence of
GDM did not differ between the two groups, 37 of 241
(15.4%) in the intervention group compared with 36 of
257 (14.1%) in the control group (relative risk 1.1, 95% CI
0.71–1.66, P5.71).
CONCLUSIONS: A mobile health-supported behavioral
intervention did not decrease the incidence of GDM.
CLINICAL TRIAL REGISTRATION: ISRCTN registry,
https://www.isrctn.com/, ISRCTN29316280.
(Obstet Gynecol 2018;131:818–26)
DOI: 10.1097/AOG.0000000000002582
G estational diabetes mellitus (GDM) is “glucose
intolerance first recognized during pregnancy”1
and is associated with up to a 70% risk of type 2
diabetes in later life.2 A family history of type 2 dia-
betes, maternal adiposity, and excess gestational
weight gain seem to confer the greatest risk.3,4 Despite
pregnancy being considered a “teachable moment,”
overweight and obese women often find it difficult
to change dietary and physical activity behaviors dur-
ing pregnancy.5 Recently published studies describing
combined nutrition and exercise interventions have
reported only some success in reducing GDM.2,6–9
The reason for this could be attributed to the lack of
emphasis on psychologic theories in their methodol-
ogies that are imperative for changing lifestyle behav-
iors in an already potentially unmotivated group.
Therefore, it is now recommended that lifestyle inter-
ventions should incorporate behavior change theories
into study design and methodology.10
OBSTETRICS & GYNECOLOGY
Fig. 1. Consolidated Standards of Reporting Trials flow diagram. BMI, body mass index; OGTT, oral glucose tolerance test.
Kennelly. Pregnancy Exercise and Nutrition. Obstet Gynecol 2018.
Mobile health or “mHealth” technologies are
becoming commonplace to assist in the management
of chronic illnesses and support behavior change.11
Considering that more than 70% of Irish pregnant
women use smartphones,12 mobile health offers an
opportunity to improve health behaviors in preg-
nancy. This article describes a multifaceted “healthy
lifestyle package” for overweight and obese pregnant
women, consisting of personalized low glycemic
index nutritional and physical activity advice under-
pinned by behavior change theories with reinforce-
ment through a specifically designed smartphone
application. We hypothesized that this lifestyle inter-
vention would reduce the incidence of GDM per the
International Association of Diabetes and Pregnancy
Study Group diagnostic criteria.13
MATERIALS AND METHODS
This was a single-center randomized controlled trial
with ethical approval and maternal written consent
conducted at the National Maternity Hospital, Dublin,
Ireland. Recruitment ran from March 2013 to February
2016. The final delivery occurred in August 2016. The
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trial steering committee met bimonthly. An indepen-
dent data monitor reviewed recruitment and safety data
after 250 patients had been enrolled.
Details of the full study protocol, including
eligibility criteria, recruitment and enrollment, and
data collection, have been previously published.14
Briefly, singleton pregnant women between 10 and
15 weeks of gestation with body mass indexes (BMIs,
calculated as weight (kg)/[height (m)]2) between 25.0
and 39.9 and in possession of a smartphone were re-
cruited at their first antenatal visit. Participants re-
turned for their first study visit within 2 weeks for
randomization to either the intervention or control
group. Randomization was performed using a com-
puter-generated sequence in a ratio of one to one.
The biostatistician prepared sequentially numbered,
sealed opaque envelopes, which were opened at the
first study visit. Randomized participants were strati-
fied by BMI to ensure equal numbers of overweight
and obese women in each group. As a result of the
nature of the intervention, neither participants nor
researchers were blinded to the intervention or
outcomes.
Kennelly et al Pregnancy Exercise and Nutrition 819
Table 1. Characteristics of Participants at Baseline

Characteristic Intervention Group (n5278) Control Group (n5287)

Age (y) 32.864.6 32.164.2

Nulliparous 138 (49.6) 154 (53.7)
Multiparous 140 (50.4) 133 (46.3)
Height (cm) 164.266.5 163.9611.9
Weight (kg) 79.5611.3 78.6611
BMI (kg/m2) 29.4263.6 29.1263.3
BMI category
Overweight (25–29.9) 182 (65.5) 194 (67.6)
Obese class I (30–34.9) 68 (24.4) 67 (23.3)
Obese class II (35–39.9) 28 (10.1) 26 (9.1)
Midupper arm circumference (cm) 31.462.8 31.362.8
Educational attainment
Some high school 7/262 (2.7) 6/277 (2.2)
Completed high school or 35/262 (13.4) 35/277 (12.6)
its equivalent
Some college education 67/262 (25.6) 46/277 (16.6)
Completed college education 153/262 (58.4) 190/277 (68.6)
Family history of type 2 DM 55 (19.8) 64 (22.3)
Ethnicity
Caucasian 259 (93.2) 256 (89.2)
Non-Caucasian 19 (6.8) 31 (10.8)
Glycemic index* 58.864.8 58.764.9
Glycemic load 134.9636.5 136636.3
Physical activity (METS)† 518.96496.3 507.46442.6
DM, diabetes mellitus; METS, metabolic equivalent of task.
Data are mean6SD or n (%).
P values calculated by independent-samples t tests or x2 tests.
* Dietary data available for 224 women in the intervention group and 210 in the control group at baseline.
†
Physical activity data available for 228 women in the intervention group and 236 in the control group.

Women allocated to the control group received
standard antenatal care, which in Ireland does not
consist of any uniform advice on diet, exercise, or
weight gain in pregnancy. Participants allocated to the
intervention group received standard antenatal care
plus a “Healthy Lifestyle Package.” The “Healthy
Lifestyle Package” began with a single face-to-face
education session conducted individually or in pairs.
This education session was delivered at the first study
visit and centered on targeted nutrition and physical
activity advice. The nutritional component of the
intervention focused on healthy eating in pregnancy.
Participants were encouraged to swap high glycemic
index foods for low glycemic index alternatives and
were informed about healthy carbohydrate portions.
The recommended diet was approximately eucaloric
to their typical diet.15 The exercise component of the
intervention focused on promoting the benefits and
safety of physical activity in pregnancy. Women were
advised to exercise per the American College of Ob-
stetricians and Gynecologists’ guidance,16 that is 30 mi-
nutes of moderate exercise 5–7 days per week, divided
into two 15-minute or three 10-minute periods to max-
imize metabolic benefit.17 The information received at
this education session was reinforced through the fol-
lowing delivery channels: a smartphone application,
emails every 2 weeks (sent by the research team), and
two follow-up face-to-face hospital visits at 28 and 34
weeks of gestation. The content of the emails were
standardized to a specific theme on a 2-week basis with
some discourse between the researchers and partici-
pants where individuals had specific questions. The
specifically designed smartphone application was
downloaded during the education session from the
iTunes or Google player website free of charge and con-
sisted of three components: a comprehensive database of
low glycemic index recipes, an exercise advice section,
and a homepage comprising daily nutritional and exer-
cise tips and an encouraging thought of the day. Focus
groups conducted before study inception guided the con-
tent and design of the application (see Appendix 1, avail-
able online at http://links.lww.com/AOG/B90). The
education session and its delivery channels were
informed by two main behavior change theories: control
theory and social cognitive theory.18,19 Goal setting for
dietary and exercise targets was individualized and based
on the “SMART” (Specific, Measurable, Achievable,
Relevant, and Time-specific) goals principle.18

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Table 2. Maternal Primary and Secondary Outcomes

Control Mean
Intervention Group Risk Ratio Difference Adjusted
Outcome Group (n5278) (n5287) (95% CI) (95% CI) P P
Primary outcome
GDM 37/241 (15.4) 36/257 (14) 1.1 (0.71– — .71
1.66)
Secondary outcomes
Gestational weight gain results
Baseline to 34 wk of gestation (kg) 8.964.8 1064.8 — 21.08 (21.96 to .015 .13
20.21)
Baseline to term (kg) 11.365.6 12.665.6 — 21.3 (22.49 to .027 .13
20.15)
Physical activity postintervention— 638.76436.4 464.86328 — 174 (0.04–0.17) .001 .02
METS*
Glycemic index postintervention† 56.464.5 57.964.8 — 21.47 (22.56 to .009 .13
20.37)
Glycemic load postintervention 117.5633.4 131.7636.1 — 214.24 (222.3 to .001 .02
26.19)
Exploratory analyses
OGTT results at 28 wk of gestation
(mmol/L)†
Fasting glucose, mmol/L (mg/dL) 4.4360.58 4.4360.55 — 20.002 (20.1 to .95 .95
(79.7610.4) (79.769.9) 0.09)
Glucose 1-h pp, mmol/L (mg/dL) 7.3661.9 7.4261.8 — 20.06 (20.39 to .72 .81
(132.5634) (133.6632) 0.27)
Glucose 2-h pp, mmol/L (mg/dL) 5.8161.4 5.7461.3 — 0.08 (20.16 to .52 .71
(104.4625) (103.3623) 0.31)
IOM GWG guidelines
Below guidelines 29 (17.0) 28 (14.9) 0.84 (0.56–
1.26)
Met guidelines 55 (32.2) 40 (21.3) Reference — .03 .13
Exceeded guidelines 87 (50.9) 120 (63.8) 0.82 (0.70– —
0.96)
Safety analyses
Labor and delivery outcomes (n5270) (n5275)
PET or PIH 22 (8.1) 15 (5.5) 1.4 (0.79– — .21
2.81)
Onset of labor
Spontaneous 143 (53) 156 (56.7) Reference — .56
Induction 93 (34.4) 83 (30.2) 1.13 (0.90– —
1.44)
Cesarean delivery as primary 34 (12.6) 36 (13.1) 1.02 (0.67– —
procedure 1.56)
Duration of labor (min) 258.76219.8 250.96207 — 7.8 (20.08 to .80
0.11)
Epidural 129 (47.8) 141 (51.3) 0.93 (0.78– — .44
1.1)
3rd-degree tear 4 (1.5) 4 (1.5) 1.02 (0.25– — 1.00
4.03)
Mode of delivery
Spontaneous vaginal 168 (62.2) 167 (60.7) Reference — .95
Instrumental 28 (10.4) 32 (11.6) 0.89 (0.56– —
1.42)
Elective cesarean 24 (8.9) 23 (8.4) 1.03 (0.60– —
1.76)
Emergency cesarean 50 (18.5) 48 (17.5) 1.03 (0.73– —
1.46)
Maternal metabolic parameters
Fasting glucose (mmol/L)
Baseline (mg/dL) 81.769 80.569 — 1.3 (20.4 to 2.9) .13
28 wk of gestation (mg/dL) 79.7610.8 79.769 — 20.1 (21.8 to 1.6) .95 1.00
Difference from baseline to 28 wk of 22.265.9 20.965.4 — 21.1 (22.2 to .02 .13
gestation (mg/dL) 20.1)

(continued )

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Table 2. Maternal Primary and Secondary Outcomes (continued )
Control Mean
Intervention Group Risk Ratio Difference Adjusted
Outcome Group (n5278) (n5287) (95% CI) (95% CI) P P
Insulin (pmo/L)
Baseline 65629.3 65.4640.5 — 20.51 (26.71 to .87
5.7)
28 wk of gestation 90647.2 98679.5 — 28.1 (220.3 to .19 .48
4.1)
Difference from baseline to 28 wk of 24.3631 35.9672.7 — 211.6 (222.4 to .03 .13
gestation 20.73)
C-peptide (nmol/L)
Baseline 0.4860.24 0.6360.73 — 20.001 (20.04 to .59
0.04)
28 wk of gestation 0.6360.33 0.6860.33 — 20.04 (20.1 to .21 .50
0.02)
Difference from baseline to 28 wk of 0.1460.29 0.2160.33 20.069 (20.13 to .03 .13
gestation 0.008)
HOMA2-IR index
Baseline 1.1960.54 1.1560.53 — 0.03 (20.06 to .48
0.13)
28 wk of gestation 1.6160.81 1.6760.84 — 20.05 (20.21 to .45 .71
0.09)
Difference from baseline to 28 wk of 0.4160.58 0.5460.73 — 20.13 (20.26 to .04 .13
gestation 20.003)
Total cholesterol (mmol/L)
Early (mg/dL) 207.3635 210.7639 — 25 (213.6 to .29
3.71)
28 wk of gestation, mmol/L (mg/dL) 255.6646 260647 — 20.31 (20.88 to .26 .53
0.26)
Difference from baseline to 28 wk of 48.3627 49.4635 — 20.85 (27 to 5.3) .78 .82
gestation, mmol/L (mg/dL)
Triglycerides (mmol/L)
Early (mg/dL) 132.8661 124643 — 7.1 (22.13 to .13
15.9)
28 wk of gestation (mg/dL) 186655 186660 — 20.53 (29.66 to .92 .94
10.8)
Difference from baseline to 28 wk of 57.5643 60.2640 — 22.56 (210.5 to .51 .71
gestation (mg/dL) 5.22)
HDL (mmol/L)
Early (mg/dL) 57.2617 60616.2 — 22.71 (20.54 to .07
0.27)
28 wk of gestation (mg/dL) 53.3620.5 53.3619.7 — 0.07 (23.71 to .53 .71
3.75)
Difference from baseline to 28 wk of 23.75615.8 25.41615.1 21.66 (21.31 to .27 .53
gestation (mg/dL) 4.64)
LDL (mmol/L)
Early (mg/dL) 126.1638 127.2639 21.35 (28.19 to .69
5.5)
28 wk of gestation (mg/dL)‡ 163646.7 169.3648 26.8 (215.7 to .14 .40
2.18)
Difference from baseline to 28 wk of 37.5636 40.6643 20.2.86 (210.5 to .46 .71
gestation (mg/dL) 4.75)
GDM, gestational diabetes mellitus; METS, metabolic equivalent of task; OGTT, oral glucose tolerance test; pp, postprandial; IOM, Institute
of Medicine; GWG, gestational weight gain; PET, preeclampsia; PIH, pregnancy-induced hypertension; HOMA2-IR, homeostatic model
assessment; HDL, high-density lipoprotein; LDL, low-density lipoprotein.
Data are n/N (%), n (%) or mean6SD unless otherwise specified.
P values calculated by independent-samples t tests, Fishers (n,10) or x2 tests. Adjusted P values were calculated for efficacy endpoints using
the Benjamin-Hochberg procedure.
Bold indicates statistically significant values.
* Physical activity data available for 165 women in the intervention group and 170 in the control group.
†
Dietary data available for 159 women in the intervention group and 161 in the control group.
‡
Glucose tolerance test based on Hyperglycemia and Adverse Pregnancy Outcome (HAPO) criteria.

Both study groups had a formal antenatal research had the following anthropometric measurements and
consultation at baseline and 28 and 34 weeks of blood samples collected: weight, height, BMI, midupper
gestation. At baseline and the 28-week visit, all patients arm circumference, and body composition (using

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Table 3. Neonatal Outcomes

Intervention Control Risk Ratio Mean Difference Adjusted

Outcome (n5270) (n5275) (95% CI) (95% CI) P P

Birth weight (g) 3,6016551 3,6696553 — 267.9 (2160.9 to .15 .40

25.03)
4,500 or greater 8 (3) 15 (5.5) 0.54 (0.23– — .69 .80
1.26)
4,000 or greater 58 (21.5) 67 (24.4) 0.88 (0.64–1.2) — .47 .71
2,500 or less 8 (3) 4 (1.5) 2.3 (0.62–6.7) — .38 .50
LGA
90th centile or greater 11 (4.1) 24 (8.7) 0.46 (0.23– — .03 .13
0.93)
95th centile or greater 3 (1.1) 11 (4) 0.28 (0.07– — .05 .15
0.98)
SGA
10th centile or less 28 (10.4) 26 (9.5) 1.09 (0.66– — .77 .82
1.82)
5th centile or less 16 (5.9) 13 (4.7) 1.2 (0.61–2.5) — .57 .72
Safety analyses
NICU admission 44 (16.3) 35 (12.7) 1.28 (0.85– — .27
1.93)
Cord blood analysis
Cord glucose (mg/dL) 73.8622 75.6622 — 20.8 (26.1 to 4.5) .76 .82
Cord insulin (pmo/L) 44.6642 49.6646 — 24.9 (216 to 6.2) .62* .76
C-peptide (nmol/L) 0.1360.17 0.1160.15 — 0.01 (20.02 to 0.05) .48* .71
Total cholesterol (mg/ 68.1622 69.2624 — 21.2 (26.9 to 4.6) .68 .80
dL)
Triglycerides (mg/dL) 53.1621 49.6623 — 3.5 (22.65 to 8.9) .25 .53
HDL (mg/dL) 21.267 22.867 — 21.93 (23.8 to 20.08) .04 .13
LDL (mg/dL) 37.5625 34.4624 — 3.1 (23.3 to 9.43) .34 .64
LGA, large for gestational age; SGA, small for gestational age; NICU, neonatal intensive care unit; HDL, high-density lipoprotein; LDL, low-
density lipoprotein.
P values calculated by independent-samples t tests, Fisher (n,10), or x2 tests. Adjusted P values were calculated for efficacy endpoints using
the Benjamini-Hochberg procedure centiles calculated per gestation-related optimal weight (GROW) birth weight centiles.
Data are mean6SD or n (%) unless otherwise specified.
* Log-transformed P value.

Impedimed SFB7 Bio-electrical Impedance Analysis).
Maternal weight was recorded at each antenatal consul-
tation. The last measured weight taken before delivery
was recorded from medical charts and used to compute
total gestational weight gain. Fasting blood samples were
collected for measurement of glucose, insulin, C-pep-
tide, and lipids and at 28 weeks of gestation, these blood
samples were followed by a 2-hour oral glucose
tolerance test performed according to the International
Association of Diabetes and Pregnancy Study Groups
criteria.13 Gestational diabetes mellitus was confirmed if
at least one glucose value was at or above the following:
fasting 92 mg/dL or greater, 1 hour 180 mg/dL or
greater, and 2 hour 153 mg/dL or greater. Additional
data were recorded from the medical charts, including
relevant medical and family history of diabetes.
At 34 weeks of gestation, maternal weight was
recorded. We assessed fetal biometry ultrasonographi-
cally at 34 weeks of gestation including a measurement of
fetal anterior abdominal wall width, fetal midthigh sub-
cutaneous tissue, and fetal thigh circumference as reported
previously.14 At delivery, cord blood was taken and neo-
nates’ birth weight, length, and head circumference were
recorded to calculate the Ponderal index (1003mass in
g/height in cm3). The Gestation Network’s Bulk Calcula-
tor 6.2.3 UK was used to calculate birth weight centiles.
The following data were also obtained from medical re-
cords: time of labor onset, mode of delivery, adverse
maternal events, and admissions to the neonatal unit.
All participants in both groups were provided
with two 3-day food diaries to quantify glycemic index
and glycemic load intakes and two validated preg-
nancy exercise and lifestyle surveys to ascertain
self-reported physical activity levels20—at baseline
(preintervention) and in the third trimester (postinter-
vention). The glycemic index and glycemic load of
foods were calculated from food diaries analyzed with
Nutritics Professional 3.09. The glycemic load of food
pertains to a number that approximates how much
a particular food will increase an individual’s blood

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glucose level after consuming it. The glycemic index
is a measure of how foods that contain carbohydrates
increase blood glucose levels.
The prespecified primary outcome was incidence
of GDM at 28–30 weeks of gestation. Prespecified
maternal secondary outcomes were: gestational
weight gain, glycemic index, glycemic load, and self-
reported exercise levels in the third trimester. Other
secondary outcomes collected for exploratory and
subgroup analysis included neonatal birth weight,
Ponderal index, and the incidence of large for gesta-
tional age (LGA), that is, birth weight greater than the
90th centile.
The rate of GDM in those with BMIs greater than
25 is 12–15%.21 To reduce GDM to a rate of 7.2%, we
estimated that 506 women would be required to have
80% power to detect this effect size at a significance of
.05, that is, 253 in each arm. The Finnish Gestational
Diabetes Prevention (RADIEL) study was a random-
ized controlled trial of a lifestyle intervention in the
pregnancies of obese women and reduced the inci-
dence of GDM from 21.6% to 13.9%, that is,
a 35.6% reduction.2 Therefore, we considered that
a reduction from 15% to 7.2% could be achievable
in this population. All statistical analyses were per-
formed using IBM SPSS for Windows 22.0. Partici-
pants were analyzed per their originally assigned
groups. Variables were graphically assessed for nor-
mality using histograms. Primary analysis was per-
formed with a x2 test with GDM as the primary
outcome. Independent-sample t tests were used for
comparison of means and x2 and Fisher exact tests
used to compare categorical variables between the
two groups. Treatment effects for binary endpoints
are expressed as risk ratios (relative risk) with 95%
CIs and mean differences with 95% CIs for continu-
ous variables. Analysis of the mean change in mater-
nal anthropometric and metabolic measurements was
performed using independent-sample t tests. We
apply a correction to control the false discovery rate
over 47 secondary and exploratory efficacy tests using
the Benjamini-Hochberg procedure. This is a less con-
servative procedure than the common Bonferroni cor-
rection; it controls the number of false-positive results
rather than the probability of at least one false-positive
(Appendix 1, http://links.lww.com/AOG/B90).22
RESULTS
Between March 2013 and February 2016, 1,858
women were assessed for eligibility and 565 women
were recruited and randomized (278 in the interven-
tion and 287 in the control arm) (Fig. 1). A total of 241
(87%) and 257 (90%) women completed the oral
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glucose tolerance test and could be assessed for the
primary outcome. Mean BMI of participants was 29.3
and mean gestational age 15.5 weeks. The groups had
similar demographic characteristics (Table 1).
Mean6SD of participants in the intervention group
who used the application was, on average, 2.462.8
times per week and for an average of 16.268 weeks.
The primary study outcome (incidence of GDM)
did not differ between the two groups, 37 of 241
(15.4%) in the intervention group compared with 36
of 257 (14.1%) in the control group (relative risk 1.1,
95% CI 0.71–1.66, P5.71).
Women in the intervention group had signifi-
cantly less gestational weight gain (Table 2). The inter-
vention resulted in lower dietary glycemic index and
glycemic load and increased exercise compared with
women in a control group (Table 2). However, only
differences in dietary glycemic load and exercise par-
ticipation persisted after multiple correction testing.
After the intervention, there was no difference
between the groups in midupper arm circumference
(31.563 cm vs 31.762.7 cm, P5.5), but less whole
body fat mass in the intervention group compared
with women in the control group, in the third trimes-
ter (30.967.3 kg vs 33.368.3 kg, P5.04, adjusted
P5.12). There was no difference between the groups
in mean6SD blood loss at delivery (449.56275.4 mL
vs 433.16245.7 mL, P5.82), postpartum hemorrhage
(blood loss greater than 500 mL) (19.5% vs 19.6%,
P5.99), antenatal admissions (34.2% vs 32.1%
P5.59), or other labor and delivery outcomes
(Table 3). There was no difference in maternal lipid
profile and markers of glucose homeostasis between
groups (Table 2).
There was no difference between the groups in
the following prenatal and postnatal characteristics:
estimated fetal weight at 34 weeks of gestation
(2,520.46292 g vs 2,535.36283.8 g, P5.57), Ponderal
index (2.7160.3 vs 2.7560.5, P5.38), birth weight,
and cord blood parameters (Table 3). There was one
unexplained stillbirth at greater than 37 weeks of ges-
tation and one preterm delivery with subsequent neo-
natal death in the intervention group. There was one
miscarriage in the intervention group and two in the
control group.
DISCUSSION
This multifaceted behavioral lifestyle intervention
incorporating dietary and physical activity advice
with reinforcement using mobile health technology
did not lower the rate of GDM. However, among
prespecified secondary outcomes, the intervention
was found to exert a beneficial influence on lifestyle
OBSTETRICS & GYNECOLOGY
behaviors by way of reducing dietary glycemic load
and increasing exercise participation.
Because glucose is important both in the devel-
opment of GDM and for fetal growth, attenuation of
maternal glucose in pregnancy by manipulation diet
and exercise is a reasonable clinical target for inter-
vention trials. However, it is possible that the magni-
tude of the observed dietary and physical activity
changes in this lifestyle intervention was insufficient to
alter GDM rates. Our results are consistent with
others; two recently published large randomized
controlled trials were unsuccessful in showing a posi-
tive effect of a behavioral lifestyle intervention on
GDM.9,23 Recent interest has focused on pharmaco-
logic interventions, but two recent studies did not find
that metformin-supported lifestyle interventions
reduced GDM rates (Balani J, Hyer S, Shehata H.
Metformin versus placebo in obese pregnant women
without diabetes [letter]. N Engl J Med
2016;374:2502.).24 Interventions during the precon-
ception period may hold potential to reduce
GDM25; however, considerable work is required to
show that prepregnancy interventions are effective.
This intervention did result in greater self-
reported exercise participation by the third trimes-
ter. This is important because physical activity tends
to decline with advancing gestation. The interven-
tion involved a face-to-face education session and
incorporated SMART goals, techniques that have
been shown to improve exercise behaviors in
pregnancy.10 This intervention also resulted in
lower dietary glycemic load intakes by the third tri-
mester. A low glycemic index dietary intervention
has been shown previously to improve maternal
dietary intakes,26 reduce GWG, and improve glu-
cose homeostasis.20 Future dietary analysis in this
cohort will confirm whether women improved other
macro- and micronutrient intakes. Initial unadjusted
analysis showed that the mean gestational weight
gain in the intervention group was significantly
lower than the control group. In addition, a post
hoc exploratory analysis revealed fewer neonates
in the intervention group were born LGA. Because
this was not a prespecified outcome, this finding
awaits replication. A potential reduction in LGA is
important because neonates at the higher end of the
birth weight centile have increased rates of child-
hood obesity and future cardiovascular and meta-
bolic morbidity.27 Our preliminary findings are
supported by the results of the LIMIT study, which
noted lower rates of neonates born at greater than 4
kg,23 and the Nelli study, which reported lower
birth weight and fewer neonates born LGA.8 All
VOL. 131, NO. 5, MAY 2018
Copyright Ó by American College of Obstetricians
and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
of these results, however, have to be interpreted
with caution because they did not persist after mul-
tiple testing corrections.
Few studies have looked at the effect of mobile
health technology to improve pregnancy outcomes.
This trial was well designed with stratified randomi-
zation ensuring equal numbers of overweight and
obese women in each group. Enrollment rates and
prespecified sample sizes were also achieved. This
study is also novel in its incorporation of mobile
health technology and behavior change techniques in
the intervention. We argue the adjustment for multi-
ple testing for secondary and exploratory efficacy
outcomes gives us more reassurance that the inter-
vention effect on exercise and glycemic load is robust.
We note that this interpretation of the adjusted P val-
ues is in contrast to a more traditional Bonferroni
correction. The false discovery rate procedure enables
one to take the unadjusted P,.05 level and inspect the
adjusted P value as a direct estimate of the proportion
expected to be false below that threshold given the
number of tests conducted. Although not a solution
for the multiplicity problem, this approach frames the
problem for the reader and gives them more useful
information with which to make a determination of
“significance.” The primary limitation of the study is
that dietary intake and exercise behaviors were self-
reported and potentially subject to underreporting or
overreporting. Also, the absence of access to a smart-
phone potentially excluded 30% of lesser affluent and
able women. Additionally, we may have had a slightly
different cohort and study results if early pregnancy
screening for diabetes was performed. However, rou-
tine practice in many countries does not involve
screening for diabetes early in pregnancy based on
risk factors.
Although this mobile health-supported interven-
tion did not affect GDM rates, it did result in some
maternal benefits. This study used mobile health
technology to support a traditional face-to-face con-
sultation and facilitated positive behavior change. The
use of mobile health technology supporting a low
glycemic index diet and physical activity intervention
with routine antenatal care in at-risk women is
a simple, safe, and effective measure to improve
maternal exercise levels and improve dietary glyce-
mic load.
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