Research www.AJOG .

org

OBSTETRICS
The Treatment of Obese Pregnant Women (TOP) study: a
randomized controlled trial of the effect of physical activity
intervention assessed by pedometer with or without dietary
intervention in obese pregnant women
Kristina M. Renault, MD; Kirsten Nørgaard, DMSc; Lisbeth Nilas, DMSc; Emma M. Carlsen, MD; Dina Cortes, DMSc;
Ole Pryds, DMSc; Niels J. Secher, MD

OBJECTIVE: The objective of the study was to assess physical activity
intervention assessed by a pedometer with or without dietary inter-
vention on gestational weight gain (GWG) in obese pregnant women by
comparing with a control group.
STUDY DESIGN: This study was a randomized controlled trial of 425
obese pregnant women comparing 3 groups: (1) PA plus D, physical
activity and dietary intervention (n ¼ 142); (2) PA, physical activity
intervention (n ¼ 142); and (3) C, a control group receiving standard
care (n ¼ 141). All participants routinely in gestational weeks 11-14
had an initial dietary counseling session and were advised to limit GWG
to less than 5 kg. Physical activity intervention included encourage-
ment to increase physical activity, aiming at a daily step count of
11,000, monitored by pedometer assessment on 7 consecutive days
every 4 weeks. Dietary intervention included follow-up on a hypo-
caloric Mediterranean-style diet. Instruction was given by a dietician
every 2 weeks. The primary outcome measure was GWG, and the
secondary outcome measures were complications of pregnancy and
delivery and neonatal outcome.
RESULTS: The study was completed by 389 patients (92%). Median values
of GWG (ranges) were lower in each of the intervention groups (PA plus D, 8.6
[e9.6 to 34.1] kg, and group PA, 9.4 [e3.4 to 28.2] kg) compared with the
control group (10.9 [e4.4 to 28.7] kg [PAþD vs C]; P ¼ .01; PA vs C; P ¼
.042). No significant difference was found between the 2 intervention groups.
In a multivariate analysis, physical activity intervention decreased GWG by a
mean of 1.38 kg (P ¼ .040). The Institute of Medicine’s recommendations
for GWG were more frequently followed in the intervention groups.
CONCLUSION: Physical activity intervention assessed by pedometer
with or without dietary follow-up reduced GWG compared with controls
in obese pregnant women.
Key words: diet, intervention, obesity, pedometer, physical activity,
pregnancy

Cite this article as: Renault KM, Nørgaard K, Nilas L, et al. The Treatment of Obese Pregnant Women (TOP) study: a randomized controlled trial of the effect of physical
activity intervention assessed by pedometer with or without dietary intervention in obese pregnant women. Am J Obstet Gynecol 2014;210:134.e1-9.

O ver the past 3 decades, the incidence

of obesity among children and ad-
olescents has increased dramatically.1
for several pregnancy and delivery
complications such as gestational diabetes,
gestational hypertension, and preeclamp-
The risk of macrosomia as well as
the risk of pregnancy complications
are independently related to gestational
In Europe the incidence of overweight sia.3,4 The risk of giving birth to a mac- weight gain (GWG),5 and high GWG
(body mass index [BMI] 25-29.9 kg/m2) rosomic neonate increases proportionally is a predictor of obesity in infancy
or obesity (BMI >30 kg/m2) among with increasing BMI.3 Birth traumas, se- and adulthood.6,7 The 2009 Institute
pregnant women ranges between 33% vere asphyxia, and neonatal hypoglycemia of Medicine (IOM) recommendations
and 50%.2,3 Obesity is a high-risk factor are all related to fetal macrosomia. advise obese women to limit their GWG
to 5-9 kg.8 Additional weight gain is
associated with a risk of 2- to 3-fold ex-
From the Departments of Obstetrics and Gynecology (Drs Renault, Nilas, and Secher),
cess weight retention after birth.9 Some
Endocrinology (Dr Nørgaard), and Pediatrics (Drs Carlsen, Cortes, and Pryds), Hvidovre Hospital,
University of Copenhagen, Hvidovre, Denmark. observational studies indicate that these
Received June 11, 2013; revised Aug. 12, 2013; accepted Sept. 18, 2013.
limits for gestational weight gain are
optimal for the outcome of mother and
This study was supported by the Sygekassernes Helsefond and Broedrene Hartmann Fonden.
child,10 and even a GWG of 5 kg or
The authors report no conflict of interest.
less may reduce the number of compli-
Presented, in part, at the first Nordic Congress on Obesity in Gynecology and Obstetrics, Billund,
cations without increasing the number
Denmark, Oct. 22-24, 2012, and the 44th annual meeting of the Diabetes in Pregnancy Study Group,
Lille, France, Oct. 18-21, 2012. of adverse outcomes.11,12
Reprints: Kristina Renault, MD, Department of Obstetrics and Gynaecology, Odense University
There are good opportunities to intro-
Hospital, Sdr Boulevard 29, 5000 Odense C, Denmark. Krenault@dadlnet.dk. duce lifestyle interventions during the
0002-9378/$36.00  ª 2014 Mosby, Inc. All rights reserved.  http://dx.doi.org/10.1016/j.ajog.2013.09.029 antenatal period. A recent metaanalysis13
concluded that lifestyle interventions in

134.e1 American Journal of Obstetrics & Gynecology FEBRUARY 2014

www.AJOG.org
pregnancy can reduce GWG.13 Physical
activity during pregnancy reduces the risk
of macrosomia14 and gestational dia-
betes15 but may be difficult to achieve.16
An economic evaluation of nonphar-
macological interventions for weight
management in nonpregnant women,
undertaken by the National Institute for
Health and Clinical Excellence, found that
diet-based interventions were less costly
than interventions based on physical
activity.17
Only a few studies have measured the
isolated effect of a physical activity inter-
vention based on a pedometer. Few studies
have shown a beneficial effect on type 2
diabetes,18,19 and some have resulted in a
modest weight loss in nonpregnant obese
participants.20 A randomized controlled
study has shown that a pedometer-based
intervention could reduce weight reten-
tion after birth,21 but no studies have
investigated the isolated effect of a
pedometer intervention on weight gain
during pregnancy.
The present study of obese pregnant
women was designed to measure the ef-
fect on maternal GWG of an inexpensive
physical activity intervention assessed by
a pedometer with or without dietary
intervention by comparing with a con-
trol group.
Furthermore, we assessed whether
lifestyle intervention reduced incidences
of pregnancy and delivery complications.
M ATERIALS AND M ETHODS
A prospective, randomized controlled
trial was conducted from March 2009 to
March 2012 at Hvidovre Hospital, Uni-
versity of Copenhagen, with 7000 de-
liveries annually. All pregnant women
with a prepregnancy BMI of 30 kg/m2 or
greater were identified when booking for
the initial ultrasound nuchal trans-
lucency scan. They were offered one
consultation with a dietician as soon as
possible after the ultrasound examina-
tion in gestational weeks 11-14, which is
routine practice in the department.
The consultation consisted of an in-
dividual recommendation of a hypo-
caloric low-fat diet with 1200-1675 kcal
(5000-7000 KJ), corresponding to a
Mediterranean-style diet which covers
preference of polyunsaturated fat by
intake of fish and oils. The diet was based
on the Danish national recommenda-
tions for a healthy diet.22 Only oral
advice was given, and no meal plan was
offered. After the dietary advice, eligible
women were asked to participate in the
study. To reduce GWG as much as
possible by the intervention, all partici-
pants were advised by the dietitian to
aim for a GWG less than 5 kg, which in
other studies seems to be safe.
Inclusion criteria were age older than
18 years, a singleton pregnancy, and a
normal scan in weeks 11-14, gestational
age (GA) at inclusion of less than 16
weeks, and an ability to read and speak
Danish. Subjects were excluded if they
had a multiple pregnancy, pregestational
diabetes, or other serious diseases lim-
iting their level of physical activity, pre-
vious bariatric surgery, or alcohol or
drug abuse.
After written informed consent was
obtained, the women were randomized by
the dietitian into 3 groups (1:1:1): (1)
group PA plus D received mixed inter-
vention with follow-up on dietary advice
and encouragement to increase physical
activity as assessed by pedometer; (2)
group PA was encouraged to increase
physical activity as assessed by pedometer;
and group C served as the control group
and received the usual hospital standard
regimen for obese pregnant women.
The randomization was stratified ac-
cording to parity to ensure equal distri-
bution of primiparous in the 3 groups.
Web allocation by an independent orga-
nization (Trial Partner, Public Health and
Quality Improvement, Department of
Data Management, Central Denmark Re-
gion) properly concealed the procedure.
The women allocated to physical ac-
tivity intervention (groups PA plus D and
PA) were immediately after randomiza-
tion individually advised and encouraged
by the dietitian to increase physical ac-
tivity, aiming at a daily step count of
11,000, which corresponds to 150%
of the average step count in healthy
lean pregnant women.23 Physical activity
was monitored by a validated pedo-
meter: a Yamax Digiwalker CW-700/750
(Yamax Corporation, Tokyo, Japan)24
counting the daily number of steps was
provided to each participant.
FEBRUARY 2014 American Journal of Obstetrics & Gynecology
Obstetrics Research
Daily step counts were registered on 7
consecutive days every 4 weeks. The
women were contacted with a reminding
text message when a recording period
started, with encouragement to obtain
the 11,000 daily steps. If this was not
obtainable, they were asked to set their
own target. The pregnant women them-
selves registered the actual weight and
daily pedometer-assessed step counts on
a chart and returned it to the department.
They did not receive any feedback on
their reporting of weight and step count.
The dietary intervention consisted of
contact with an experienced dietitian every
2 weeks, alternating between outpatient
visits and phone contacts (11-13, de-
pending on length of gestation). Follow-
up included measurement of weight,
encouragement, and correcting advice on
the diet if the weight gain was greater than
aimed for or if the participant reported an
incorrect diet.
Additional demographic data includ-
ing smoking history, educational level,
and data about prepregnancy physical
activity were recorded at inclusion. The
level of prepregnancy physical activity
was self-evaluated in a simple validated
questionnaire to detect whether there
was any baseline difference between the
3 groups.25
Several additional tests were per-
formed. A test for gestational diabetes
mellitus (GDM) was performed. The
women were tested for GDM twice
with a 75-g, 2-hour standard oral glucose
tolerance test (OGTT) at gestational weeks
17-20 and 27-30. If gestational diabetes
was diagnosed, care continued in the
multidisciplinary diabetic clinic, but the
patient was not excluded from the study.
Weight was measured on an elec-
tronic scale (Model Sv-Seca 769; Seca,
Hamburg, Germany), with the woman
wearing light indoor clothes and no
shoes at inclusion and at gestational
weeks 18-22 and 36-37.
GWG was calculated as the weight
measured at a visit during gestational
weeks 36-37 minus the self-reported
prepregnancy weight.
Pregnancy complications and mode of
delivery were extracted from hospital
files and validated using the Danish na-
tional guidelines (DSOG guidelines).
134.e2
Research Obstetrics www.AJOG.org

FIGURE 1
Flow diagram

Eligible in the inclusion period (n = 758)

Enrollment 30kg/m², given written information
and invited.

Cancelled appointment or did not show up. (n

= 244)

Dietary consultation
Assessed for eligibility (n = 514)

Not meeting inclusion criteria (n = 29)

Considerable disease or multiple
pregnancy (n = 13)
Linguistic problems (n = 16)

Declined to participate (n = 60)

Randomized (n = 425)

Allocation

Intervention group PA+D (n = Intervention group PA (n = 142) Control group C (n = 141)

142) Received: intervention with Received: no intervention,
Received: dietary intervention and pedometer standard care
intervention with pedometer

Follow-up

Lost to follow-up (n = 12) Lost to follow-up (n = 17) Lost to follow-up (n = 7)

Miscarriage (n = 2) Miscarriage (n = 3) Abortion (n = Miscarriage (n = 1)
Withdrew (n = 9) 1) Withdrew (n = 2)
Moved out of the region (n = 1) Withdrew (n = 11) Moved out of the region (n =
Moved out of the region (n = 2) 4)

Analysis (n = 389)

Analyzed at delivery (n = 130) Analyzed at delivery (n = 125) Analyzed at delivery (n = 134)

Selection, allocation, and participation in the Treatment of Obese Pregnant Women (TOP) study.
Renault. RCT: pedometer assessed intervention and diet intervention in obese pregnant women. Am J Obstet Gynecol 2014.

134.e3 American Journal of Obstetrics & Gynecology FEBRUARY 2014

www.AJOG.org Obstetrics Research

TABLE 1
Baseline characteristics of obese pregnant women randomized to 2 intervention groups: a control group and
dropouts
Group PA plus D Group PA Control group C Dropouts
Characteristic (n [ 130) (n [ 125) (n [ 134) (n [ 36) Significance
Parity
Primiparous 69 (53%) 68 (54%) 75 (56%) 24 (67%) NSa
Previous caesarean section: 10 (7.8%) 11 (8.8%) 11 (8.2%) 2 (10%) NSa
Pre-pregnancy BMI, kg/m2
Mean þ/- 1 SD 34.4  4.2 34.1  4.4 33.7  3.5 34.2  3.7 NSb
Age, y
Mean þ/- 1 SD 31.2  4.4 30.9  4.9 31.3  4.2 30.4  4.8 NSb
Caucasian, n (%) 128 (98) 123 (98) 130 (97) 31 (86)a .0011a
Smoking, n (%) 12 (9.3) 7 (5.7) 11 (8.2) 5 (13.9) NSa
Missing data 1 3 0
Quit smoking during pregnancy 2 2 0
Educational level, n (%)
Grammar school 10 y or less 11 (8.5) 17 (13.6) 16 (11.9) 5 (13.9) NSa
Secondary school 12 y 16 (12.3) 17 (13.6) 13 (9.7) 6 (16.7)
Vocational training school 41 (31.5) 37 (29.6) 34 (25.4) 11 (30.6)
or further education 1-2 y
Tertiary education 3-4 y (bachelor level) 47 (36.2) 36 (28.8) 49 (36.6) 9 (25)
Advanced education (postgraduate) 13 (10.0) 18 (14.4) 18 (13.4) 5 (13.9)
Missing data 2 (1.5) 0 (0) 4 (3.0) 0 (0)
BMI, body mass index; D, dietary intervention; GWG, gestational weight gain; NS, not significant; PA, physical activity; SD, standard deviation.
a
Pearson’s c2 test; b Kruskal-Wallis test.
Renault. RCT: pedometer assessed intervention and diet intervention in obese pregnant women. Am J Obstet Gynecol 2014.

According to these, GDM was diagnosed
if the 2-hour standard OGTT capillary
blood glucose was 9 mmol/L or greater.
Preeclampsia was defined as proteinuria
(dipstick, greater than 1þ) and persis-
tently elevated blood pressure greater
than 140/90 mm Hg on more than 1
occasion. Gestational hypertension was
diagnosed using the same criteria but
without proteinuria.
Neonatal outcome was measured.
Gestational age, placenta weight, birth-
weight, birth length, Apgar score, and
umbilical cord pH were recorded. The
actual birthweight was transformed to a
relative birthweight with a percentage
deviation from the expected weight
adjusted for gestational age and sex using
the reference population and formula
according to Marsal et al.26 This provides
an SD of 12%. Accordingly, small for
gestational age (SGA) was set to a relative
birthweight less than 76% (e2 SD) of
normal, whereas large for gestational age
(LGA) refers to a relative birthweight
124% or greater (2 SD) of normal.
Macrosomia was defined as birthweight
of 4000 g or greater.
Dropouts were defined as participants
dropping out of the study before delivery
because of miscarriage, withdrawal of
informed consent, or because they
moved out of the region.
Attendance to the dietary intervention
as well as compliance to the pedometer-
assessed physical activity intervention
was measured by filling in and returning
the forms with step counts and weight.
Ethics
This study received approval from the
Ethics Committee for the Capital Region
of Denmark (January 2009) (identifica-
tion number H-D-2008-119). The study
is registered at ClinicalTrials.gov (iden-
tification number NCT01345149).
Statistics
The power calculation relied on a pilot
study of 70 obese pregnant women with
a BMI 30 kg/m2 and a GWG of 9.1 kg
 8.5 kg.23 Thus, a total of 112 partici-
pants should be included in each group
to detect a minimal difference of 3 kg in
GWG (power, 80%; alpha, 5%, 2-sided
test). Expecting up to 20% dropouts,
we included 140 in each of the 3 groups
(n ¼ 420).
Data are presented in accordance with
their distribution: as median and ranges
or mean and SDs. Categorical data were
tested with c2 statistics or Fisher exact
test. Differences between all groups were

FEBRUARY 2014 American Journal of Obstetrics & Gynecology 134.e4

Research Obstetrics
FIGURE 2
GWG according to IOM’s criteria
% 100
90
80
70
60
50
40
30
20
10
0
PA+D PA C Group
GWG according to IOM’s criteria in the
randomization groups (n ¼ 389): PA plus D (n ¼
130), PA (n ¼ 125), and C (n ¼ 134). Asterisk
indicates dark green: GWG less than 5 kg (aimed
in the study). Double asterisks indicate medium
green: GWG 5-9 kg (followed IOM’s criteria).
Triple asterisks indicate light green: GWG
greater than 9 kg (exceeding IOM’s recom-
mendations). Group significance includes the
following: asterisk indicates P ¼ .068; double
asterisks indicate P ¼ .066; and triple asterisks
indicate P ¼ .006 (c2). The intervention groups
vs control group includes the following: asterisk
indicates P ¼ .021; double asterisks indicate
P ¼ .021; triple asterisks indicate P ¼ .010
(c2).
C, control group; D, dietary intervention; GWG, gestational weight
gain; IOM, Institute of Medicine; PA, physical activity.
Renault. RCT: pedometer assessed intervention and diet
intervention in obese pregnant women. Am J Obstet Gynecol
2014.
tested by a Kruskal-Wallis test or an
analysis of variance (ANOVA), whereas
the Mann-Whitney U test analyzed dif-
ferences between 2 groups.
The effect of diet or physical activity
intervention on GWG was tested by
multiple linear regression across the
groups. Categorical predictor variables
(0, 1) for diet and physical activity
intervention were incorporated into the
analysis together with maternal age,
parity, BMI, smoking, and education.
Finally, we evaluated the relation
between birthweight and GWG by
grouping all participants according to
recommendations of IOM.
All analyses were performed accord-
ing to the intention-to-treat approach.
The statistical package SPSS version 19
(IBM Corp, Armonk, NY) was used,
and the level of significance was set to
P ¼ .05.
134.e5 American Journal of Obstetrics & Gynecology FEBRUARY 2014
R ESULTS
In the inclusion period, 758 pregnant
women were considered eligible for in-
clusion, and 425 (56%) participated. In
total 389 women completed the study
(Figure 1).
Participants still included at delivery
GWG > 9kg
did not differ with respect to dropout rate
GWG 5-9kg
GWG < 5kg or to sociodemographic characteristics
within the 3 groups (Table 1). The
women who dropped out were more
often nonwhite. Information on weight
gain missed in 13 women because they
delivered preterm. One woman allocated
to group PA delivered in gestational week
35 and had an unexpected stillbirth
caused by placental abruption.
Women in group PA plus D attending
dietary consultations every 2 weeks could
have 11-13 contacts with the dietitian,
depending on the length of gestation. The
median number of dietary consultations
was 11 (range, 0e14) for the 130 partic-
ipants who participated until delivery.
Intervention and GWG
GWG (medians [ranges]) was as follows:
group PA plus D, 8.6 kg (e9.6 to 34.1) kg;
group PA, 9.4 kg (e3.4 to 28.2) kg;
and group C, 10.9 kg (e4.4 to 28.7)
(P ¼ .024). GWG for participants in the
intervention groups PA plus D and PA
was significantly lower than that in the
control group (P ¼ .008). Each inter-
vention per se resulted in lower GWG
compared with the control group GWG
(PA plus D vs C, P ¼ .01, and PA vs C,
P ¼ .042), but no significant difference
was found between the 2 intervention
groups: PA plus D and PA (P ¼ .57).
GWG was analyzed across the study
groups; potential predictors for low
weight gain were incorporated in a
multiple linear regression analysis.
Pedometer-assessed physical activity
intervention minimized GWG by a mean
of 1.38 kg compared with women not
assigned to the pedometer (P ¼ .040).
Furthermore, GWG decreased signifi-
cantly with increasing BMI (e0.38 kg per
kilogram per square meter; P < .0001).
However, neither dietary intervention
nor other maternal factors influenced
GWG significantly.
GWG less than 5 kg was obtained by
26% in group PA plus D, 22% in group
www.AJOG.org
PA, and 17% of the women in the control
group (P ¼ .068). The difference was
significant when comparing intervention
groups (PA plus D) plus PA and group C
(P ¼ .021) (Figure 2).
A GWG of maximal 9 kg was obtained
in 55% in group PA plus D, 49% in group
PA, and 37% in the control group (P ¼
.013) (Figure 2). The difference was sta-
tistically significantly different between
intervention groups (PA plus D) plus PA
and C (P ¼ .010).
Physical activity
In gestational week 13, 64% in group PA
plus D and 55% in group PA returned
the chart with step counts and weight,
whereas the chart was returned by 53%
and 56% in week 33. There was no dif-
ference in the compliance between the
group PA and the group allocated to
combined intervention PA plus D.
The daily pedometer-assessed step
counts were similar in groups PA plus
D and PA: in week 13, 8838  2878
and 8828  2798 steps/d (n¼ 91/78); in
week 21, 8122  3121 and 8829  2980
steps/d (n ¼ 98/94), and in week 37,
6219  2198 and 5972  2133 steps/d
(n ¼ 46/59).
Secondary outcomes
There was no significant difference in
the birthweight among the 3 interven-
tion groups, neither absolute nor after
adjusting for gestational age and sex
(Table 2).
The obstetric and neonatal outcomes
in the 3 intervention groups were similar
(Table 2), except for a lower rate of emer-
gency cesarean section in women allocated
to group PA plus D (P ¼ .015). The in-
dications for performing cesarean section
were comparable among the groups.
IOM’s recommendations for GWG and
birthweight
Stratifying the participants into 3 groups
according to whether they achieved a
GWG less than 5 kg (n ¼ 81), followed
IOM’s recommendation with a GWG of
5-9 kg (n ¼ 95), or exceeded the IOM’s
recommendation of maximal GWG of
9 kg (n ¼ 200), a higher birthweight,
absolute as well as that adjusted for sex
and gestational age, was significantly
www.AJOG.org Obstetrics Research

TABLE 2
Secondary outcomes: results given as mean ±1 SD or as median (range)
Numbers at follow-up Group PADD Group PA Control group C
(n [ 389) n [ 130 n [ 125 n [ 134 Significance
Week 17-20 OGTT (n ¼ 118) (n ¼ 113) (n ¼ 109) NSa
2-h value, mmol/L 7. 1  1.4 6.8  1.1 7.1  1.4
Week 27-30 OGTT (n ¼ 111) (n ¼ 108) (n ¼ 109) NSa
2-h value, mmol/L 6.7  1.4 6.8  1.2 6.9  1.2
Development of GDM (%) 6/103 (3.8) 2/125 (1.6) 7/134 (5.2) NSb
Blood pressure, mm Hg week 18-22
Systolic 123  1 122  1 124  1 NSa
Diastolic 77  1 75  1 76  1 NSa
Blood pressure, mm Hg week 36-37
Systolic 129  1 127  1 127  1 NSa
Diastolic 80  1 80  1 80  1 NSa
Hypertensive disease, n (%) 7 (5.4) 9 (7.2) 12 (9.0) NSb
Hypertension 5 4 9
Preeclampsia 2 5 3
Induction of labor, n (%) 47 (36.1) 42 (33.6) 46 (34.3) NSb
Cesarean section all, n (%)a 32 (25)c 51 (41) 50 (37) .016c
b d
Emergency/unplanned CS, n (%) 14 (11) 27 (22) 32 (24) .015d
Planned CS 18 (14) 24 (19) 18 (14) NSb
Gestational age, wks 278  11 278  14 278  12 NSa
Preterm delivery, n (%) NSb
Gestational age 28-34 wks 1 (1) 3 (2) 1 (1)
Gestational age 34-37 wks 3 (2) 5 (4) 5 (4)
Fetal weight, g 3605 (1945e5450) 3695 (805e4910) 3641 (1223e5280) NSa
Relative birthweight Mean: 102.6  14.7 Mean: 102.3  13.4 102.5  13.3 NSa
Median: 103.0 Median: 101.0 Median: 101.0
(59e151) (64e142) (60e137)
SGA, n (%) 7 (5.4) 4 (3.2) 2 (1.5) NSb
LGA, n (%) 9 (6.9) 8 (6.4) 9 (6.7) NSb
Birthweight >4000 g, n (%) 29 (22) 37 (30) 33 (25) NSb
pH of umbilical cord blood 7.24  0.08 7.24  0.09 7.23  0.08 NSa
Weight placenta, g 684  162 687  173 670  164 NSa
Relative birthweight is expected birthweight (percentage) adjusted for differences in GA and sex. SGA is a relative birthweight of 76% or less. LGA is a relative birthweight of 124% or greater.
CS, cesarean section; D, dietary intervention; GDM, gestational diabetes mellitus; LGA, large for gestational age; NS, not significant; OGTT, oral glucose tolerance test; PA, physical activity; SGA,
small for gestational age.
a
Kruskal-Wallis test; b Pearson’s c2 test; c PA plus D vs C; d PA plus D vs C (c2 test).
Renault. RCT: pedometer assessed intervention and diet intervention in obese pregnant women. Am J Obstet Gynecol 2014.

related to increased maternal weight
gain (P ¼ .005) (Figure 3, A) and also
when adjusting for maternal BMI, age,
parity, smoking, and GDM (P ¼ .01)
(Figure 3, B).
The risk of having a macrosomic child
(birthweight more than 4000 g) was
lower among mothers with a GWG less
than 5 kg compared with mothers with a
higher GWG, 11 of 81(14%) vs 86 of 295
(29%) (P ¼ .005). Noteworthy is that
the risk of having an SGA child was
not significantly related to a GWG
of less than 5 kg: 3 of 81 (3.7%) vs 8
of 295 (2.7%) (P ¼ .64).

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Research Obstetrics www.AJOG.org

C OMMENT
FIGURE 3
In the present study, physical activity
Relative birthweights
intervention with a pedometer resulted
A 108 in a GWG, which was 1.4 kg lower than
that of women who did not have inter-
106 vention by using a pedometer. Follow-up
on counseling by a dietitian in combi-
nation with physical activity led to a
104 modest reduction in GWG, but the
Relative BW (%)

additional effect on GWG was not sig-

102 nificant. Birthweight and the risk of
macrosomia increased with GWG, but
100 GWG less than 5 kg in obese pregnant
women did not result in SGA infants.
98 Strength and weaknesses of the
study
96 The pedometer intervention is an inex-
pensive method for increasing daily
94 physical activity and can easily be
GWG < 5kg GWG 5 - 9kg GWG > 9kg implemented into daily clinical practice.
Other physical activity interventions
often include attendance to classes,27,28
B which can be very time consuming and
115
difficult to implement into daily life. We
approached a homogenous population
110 in which more than 97% were whites.
Adjusted Relative BW (%)

The homogeneity reduces the risk of bias

but is also a weakness because it lowers
105 the external validity. Compliance to the
study was high and the dropout rate was
only 8.5%.
100 The reduction in median weight gain
in the intervention groups compared
with the control group was significant
95 but modest. This might primarily be
explained by the wide ranges, indicating
that a large part of the attendant partic-
90
ipants did not follow the dietary and
physical activity advice. So motivation is
85 also a challenge in this study. If only
GWG < 5kg GWG 5 - 9kg GWG > 9kg measuring the effect on the participants
A, Relative birthweight (percentage of the expected birthweight calculated according to Marsal compliant to the intervention, weight
et al26 and adjusted for differences in GA and sex) for participants with GWG less than 5 kg reduction might be more pronounced.
(n ¼ 81), GWG 5-9 kg (n ¼ 95), and GWG greater than 9 kg (n ¼ 200). Ninety-five percent This might also explain the lacking dif-
confidence interval for each group is shown. Group difference is significant (ANOVA P ¼ .0001). ference on birthweight across the inter-
B, Relative birthweight calculated according to Marsal et al26 adjusted for maternal BMI, age, parity, vention groups.
smoking, and GDM for participants with GWG less than 5 kg, GWG 5-9 kg, and GWG greater than
In accordance with other randomized
9 kg. Ninety-five percent confidence interval for each group is shown. Group difference is significant
controlled lifestyle intervention studies
(ANOVA P ¼ .01).
for overweight/obese nondiabetic preg-
ANOVA, analysis of variance; BMI, body mass index; GA, gestational age; GDM, gestational diabetes mellitus; GWG, gestational weight
nant women,27-33 the power may be too
gain. low to detect an effect on pregnancy
Renault. RCT: pedometer assessed intervention and diet intervention in obese pregnant women. Am J Obstet Gynecol 2014. complications. A reduction in the inci-
dence of GDM has been observed in only

134.e7 American Journal of Obstetrics & Gynecology FEBRUARY 2014

www.AJOG.org
1 Australian interventional study.32 As in
the present study, another randomized
controlled trial found a significantly lower
rate of emergency/unplanned cesarean
section in the group allocated to intensive
dietary and lifestyle counseling.34
Our inclusion criteria were wide and
only women with severe disease were
excluded. The incidence of preeclampsia
and GDM in Danish obese women is
7.6% and 8.7%, respectively,3 and com-
pared with this factor, the incidences in
our study were lower, even in the control
group. A possible explanation could be
that all participants were given an initial
routine counseling consultation before
randomization and registered their diet
early and late in the pregnancy. Further-
more, they might be more motivated for
lifestyle changes and healthier than the
nonparticipants.
The participants in this study had a
higher educational level than the general
Danish population,35 but a multivariate
regression analysis showed that educa-
tional level did not influence on GWG
significantly (data not shown).
Assessment of the interventions used
The pedometer measures almost all
physical activity during the day. One
limitation of the pedometer is that it
cannot register movements in water.
Swimming is a popular physical activity
among pregnant women, although a
very small part of the activities of daily
life. It was used not only as a tool to
promote increased physical activity in
daily life but also as an instrument for
assessing individual physical activity23,36
because step counts are easy to quantify.
In an observational study of physical
activity during pregnancy performed in
the same department as the present
study,23 women with a BMI of 30 kg/m2
or greater performed an average of 6500,
7400, and 4600 steps/d in gestational
weeks 13, 21, and 37 respectively. In the
present interventional study, the women
were encouraged and advised to be more
physically active, and in the correspond-
ing weeks, they performed on average
8800, 8500, and 6000 steps/d, so there
was an obvious effect on their behavior.
Self-monitoring and reporting of
steps could cause bias or misreporting,
and falsely high step counts would
underestimate the effect on GWG. Self-
registration of weight when registering
step counts every 4 weeks might af-
fect self-adjustment and behavior and
thereby partly explain the effect on
GWG reduction.
The dietary recommendation of a
low-fat diet with calorie restriction corre-
sponds to evidence-based recommenda-
tions for the treatment of GDM.37,38 Small
randomized trials in obese women with
GDM39,40 reported that restriction to
1200-1675 kcal daily restricted GWG
without adverse effects on perinatal
outcome. In a randomized trial addressing
obese nonpregnant diabetic subjects, a
Mediterranean diet compared with low-
carbohydrate or low-fat diets caused
weight loss and reduced insulin resistance
and fasting glucose levels.41 A Norwegian
randomized trial showed that a Mediter-
ranean diet reduced the risk of preterm
delivery.42
Our choice of diet was based on
this knowledge. A recent metaanalysis
concluded that intervention reduced
GWG and that diet intervention was
more effective than physical activity
intervention alone or mixed interven-
tion.13 In our study, the reduction of
GWG was 2.3 kg in the group receiving
regular dietary and pedometer inter-
vention and 1.5 kg in the group receiving
only pedometer intervention compared
with the participants in the control
group. However, the additive effect of the
dietary intervention was not significant.
We must be aware that all the partici-
pants in the study had an initial dietary
counseling and that we were measuring
only the effect of having a dietary follow-
up. Maybe the participants having
physical activity intervention are more
motivated for a healthier lifestyle and
therefore more compliant to the initial
dietary advice. This might reduce the
difference between the 2 groups.
The methods used seem to be safe. We
have found beneficial effects, primarily
reduction in GWG and a lower rate
exceeding the IOM’s criteria, but also a
reduction in the rate of emergency ce-
sarean section. When comparing birth-
weights of the children born of mothers
who achieved the goal (GWG <5 kg),
FEBRUARY 2014 American Journal of Obstetrics & Gynecology
Obstetrics Research
and apparently were compliant to the
dietary and physical advice, with the
women who did not, we found that the
risk of having a macrosomic child was
significantly lower among mothers with
a GWG less than 5 kg but not associated
with increased risk of intrauterine
growth restriction. This is in accordance
to a recently published study.43
Recommendations for future
research
The influence of diet composition on
risk of cesarean section should be further
investigated.
To increase knowledge about how
pregnancy, delivery, and neonatal com-
plications related to obesity can be
diminished, large longitudinal prospec-
tive studies with detailed descriptions
of the different types of dietary in-
terventions and on physical activity are
needed. Ideally, studies on interventions
or methods such as gastric bypass for
prepregnancy weight loss should also be
performed.
Conclusion
Physical activity intervention assessed by
a pedometer with or without dietary
follow-up reduced gestational weight gain
in obese pregnant women and should be
recommended. -
ACKNOWLEDGMENTS
K.M.R., K.N., L.N., and N.J.S. planned the study
and designed the research. K.M.R. coordinated
the day-to-day running of the study and con-
ducted the research. K.M.R. and K.N. analyzed
the data. K.M.R., K.N., O.P., and E.M.C. per-
formed the statistical analysis. K.M.R. wrote the
draft, and all authors contributed to the writing of
the manuscript and approved the final manu-
script. And N.J.S. and K.M.R. had the primary
responsibility for the final content.
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