ARTICLEPEDIATRICS Volume 139 , number 3 , March 2017 :e 20162037

Targeting Sleep, Food, and Activity in Infants for Obesity Prevention: An RCTBarry J. Taylor, FRACP, a Andrew R. Gray, BCom (Hons), b Barbara C. Galland, PhD, c Anne-Louise M. Heath, PhD, d Julie Lawrence, PhD, c Rachel M. Sayers, MHealSc, c Sonya Cameron, PhD, c Maha Hanna, DPH, c Kelly Dale, PhD, c Kirsten J. Coppell, FNZCPHM, e Rachael W. Taylor, PhDe

abstractOBJECTIVE: The few existing early-life obesity prevention initiatives have concentrated on

nutrition and physical activity, with little examination of sleep.

METHODS: This community-based, randomized controlled trial allocated 802 pregnant women

(≥16 years, <34 weeks’ gestation) to: control, FAB (food, activity, and breastfeeding),

sleep, or combination (both interventions) groups. All groups received standard well-child

care. FAB participants received additional support (8 contacts) promoting breastfeeding,

healthy eating, and physical activity (antenatal–18 months). Sleep participants received

2 sessions (antenatal, 3 weeks) targeting prevention of sleep problems, as well as a sleep

treatment program if requested (6–24 months). Combination participants received both

interventions (9 contacts). BMI was measured at 24 months by researchers blinded to

group allocation, and secondary outcomes (diet, physical activity, sleep) were assessed by

using a questionnaire or accelerometry at multiple time points.

RESULTS: At 2 years, 686 women remained in the study (86%). No significant intervention

effect was observed for BMI at 24 months (P = .086), but there was an overall group effect

for the prevalence of obesity (P = .027). Exploratory analyses found a protective effect for

obesity among those receiving the “sleep intervention” (sleep and combination compared

with FAB and control: odds ratio, 0.54 [95% confidence interval, 0.35–0.82]). No effect

was observed for the “FAB intervention” (FAB and combination compared with sleep and

control: odds ratio, 1.20 [95% confidence interval, 0.80–1.81]).

CONCLUSIONS: A well-developed food and activity intervention did not seem to affect children’s

weight status. However, further research on more intensive or longer running sleep

interventions is warranted.

Departments of athe Dean, Dunedin School of Medicine, bPreventive and Social Medicine, cWomen’s and

Children’s Health, dHuman Nutrition, and eMedicine, University of Otago, Dunedin, New Zealand

Prof B Taylor is the co-principal investigator of the Prevention of Overweight in Infancy (POI)

study, contributed to study design, co-led the sleep intervention, co-wrote the manuscript, and

directed the statistical analyses; Mr Gray contributed to study design, designed and completed

all statistical analyses, and wrote the relevant sections of the manuscript; Dr Galland contributed

to study design, co-led the sleep intervention, and reviewed and revised the manuscript; Dr Heath

contributed to study design, co-led the FAB (food, activity, and breastfeeding) intervention, and

reviewed and revised the manuscript; Dr Lawrence contributed to study design, coordinated and

led the management of the study, and reviewed and revised the manuscript; Ms Sayers delivered

the sleep intervention, and reviewed and revised the manuscript; Drs Cameron, Hanna, and Dale

contributed to data collection, and reviewed and revised the manuscript; Dr Coppell contributed

to study design, and reviewed and revised the manuscript; and Prof R Taylor is the co-principal

investigator of the POI study, contributed to study design, co-led the FAB intervention, co-wrote the

manuscript, and directed the statistical analyses; and all authors approved the fi nal manuscript

as submitted. To cite: Taylor BJ, Gray AR, Galland BC, et al. Targeting

Sleep, Food, and Activity in Infants for Obesity Prevention:

An RCT. Pediatrics. 2017;139(3):e20162037

WHAT’S KNOWN ON THIS SUBJECT: Obesity

prevention in early life has concentrated on

changing nutrition and activity in infants, with

relatively little success. Although sleep is strongly

associated with weight in observational research,

few interventions have investigated the effectiveness

of sleep modifi cation for obesity prevention.

WHAT THIS STUDY ADDS: An intervention targeting

food, activity, and breastfeeding did not seem to

affect infants’ weight status. Exploratory analyses of

the sleep intervention suggest that further research

based on more intensive or longer running sleep

interventions is warranted.

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TAYLOR et al

Rapid increases in childhood

obesity, 1 and the strong relationship

between early rapid growth and

subsequent obesity, 2 have focused

attention on early prevention. 3

Although preschool initiatives have

shown some success, 4 relatively

few studies exist in children aged

<2 years.5 Three Australian studies

have modified some obesity-related

behaviors in toddlers and parents, 6 – 8

but only 1 study has significantly

affected BMI at 2 years of age. 6

Early-life obesity prevention has

typically focused on encouraging

healthy eating and increasing

physical activity, with surprisingly

inconsistent results, 4, 5 thus

prompting interest in assessing

other behaviors (including sleep). 9

Observational studies support a

strong inverse association between

sleep duration and obesity in

childhood, 10 and plausible biological

mechanisms (eg, changes to eating/

activity habits or appetite-regulating

hormones) exist to explain this

relationship.11 However, whether

sleep behavior can change weight

trajectories early in life has not been

well studied. Existing trials are small

and/or target several behaviors as

well as sleep 12 – 14 or commence later

in infancy. 15

Despite the existence of a strong

well-child health care system in

New Zealand, 16 1 in 3 children

are overweight or obese by 2 to

4 years of age. 17 The aim of the

POI (Prevention of Overweight in

Infancy) study was to determine

whether a conventional approach

(food, activity, and breastfeeding

intervention [FAB]), and/

or an indirect approach (sleep

intervention), to obesity prevention

would result in lower BMI at 2 years

of age compared with standard care.

METHODS

POI was a 2-year, randomized

controlled trial with 4 arms:

control (usual care), FAB, sleep,

and combination (FAB and sleep)

conducted in a single center

(Dunedin, New Zealand). Because

the protocol is published, 18 only

essential details are presented here.

Ethical approval was obtained from

the Lower South Regional Ethics

Committee (LRS/08/12/063), and

adult participants provided written

informed consent. All pregnant

women booking into the only birthing

unit in Dunedin from May 2009 to

November 2010 were eligible if they

were aged ≥16 years, <34 weeks’

gestation, able to communicate in

English or Te Reo Māori (indigenous

language), and planning to live locally

for 2 years. Infants were excluded

after birth if gestation was <36.5

weeks or they had a congenital

abnormality or physical/intellectual

disability likely to affect feeding,

physical activity, or growth.

Participants were randomly assigned

to 1 of 4 study arms, within 6

strata depending on household

deprivation (3 levels) and parity

(2 levels) by using a block size of

12. Allocation was concealed by

using opaque presealed envelopes.

Those delivering or receiving the

interventions could not be blinded,

but all anthropometric assessments

were performed by researchers

blinded to group allocation, and the

biostatistician used uninformative

group codes until primary analyses

were completed.

Participants in all 4 groups received

standard government-funded well-

child care (7 core visits from 2–4

weeks to 2 years of age). 19 Families

in the intervention groups received

additional guidance and support

( Fig 1). Those in the FAB group

received 8 parent contacts, 20

including 3 from an international

board-certified lactation consultant

promoting breastfeeding and

delaying the introduction of solids

until 6 months. 21 Trained researchers

(nurses, dietitians, and nutrition

graduates) discussed with parents

(predominantly mothers) nutrition

behaviors believed to affect weight

in face-to-face individual sessions

at 7, 13, and 18 months of age. The

local “Sport Otago” trust held 3

group activity sessions with families

to illustrate how to be active with

infants and limit time in sedentary

activities. Those in the sleep group

received a sleep problem prevention

program in 2 contacts (antenatal

and 3 weeks) regarding developing

appropriate sleep habits from birth

(trained nurse). Emphasis was on the

following: (1) recognizing tired signs

and putting the infant down to sleep

while awake; (2) without associated

settling behaviors (eg, feeding); (3)

in a quiet, slightly darkened area;

and (4) using safe sleep practices.18, 22

Parents who indicated their child’s

sleep was a problem from 6 months

of age were offered a more intensive

personalized intervention, adhering

to modified “extinction” techniques. 18

Overall, 26.6% of parents in the sleep

and combination groups received

this extra support. Families in the

combination group received the FAB

and sleep interventions condensed

into 9 contacts (combined antenatal

education sessions).

Outcomes

Demographic information obtained

at baseline (19–39 weeks’ gestation)

included maternal date of birth,

ethnicity, parity, education, income,

and address (measures household

deprivation 23). Maternal pre-

pregnancy BMI was calculated from

self-reported weight at baseline and

height measured when the infant

was 6 months of age. Anthropometric

measures were obtained from

hospital data at birth and by trained

researchers at 6, 12, 18, and 24

months of age following World

Health Organization protocols. 24

BMI-for-age z score was calculated by

using the World Health Organization

growth standards, 25 with overweight

and obesity defined as the ≥85th and

≥95th percentiles, respectively. BMI

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PEDIATRICS Volume 139 , number 3 , March 2017

and weight status at 24 months were

the primary outcomes.

Secondary outcomes were assessed

by using face-to-face interviews

and telephone questionnaires.

Exclusive breastfeeding (no other

liquids or solids since birth) and full

breastfeeding (no other liquids or

solids in the past 48 hours) status

to the nearest day were derived

from questionnaires administered

every 4 weeks from 3 to 27 weeks

of age. 18 Dietary intake was

assessed by using a validated food

frequency questionnaire 26 at 12

and 24 months. 20 Parents indicated

how many minutes per week their

child spent playing actively outside

and inside and watching television

at multiple time points. Sleep

duration was assessed according to

questionnaire responses (parents

indicated bed and wake times)

and accelerometric findings (24

months only). Children wore ActiCal

accelerometers (Philips Respironics,

Murrysville, PA) over the right hip

24 hours per day for 5 to 7 days,

and sleep duration was estimated

by using an automated algorithm. 27

Parents reported the number of

nights their child typically woke

during the week and whether their

child’s sleep was a problem (using an

8-point scale). Questions at 12 and

24 months asked the extent to which

parents helped their child go to sleep

(eg, by touching them, intervening

when they woke in the night), who

they had received sleep advice from

(other than POI), and the usefulness

of that advice. Quality of family

3

FIGURE 1POI intervention visits delivered to participants in the FAB, sleep, and combination groups from antenatal to 2 years’ postpartum. Families in the combination group received the FAB and sleep interventions. aIn addition to the lactation consultant contacts provided by the study, all participants in the FAB and combination groups could also request additional support from the lactation consultant from antenatal to 6 months’ postpartum. b“You provide–they decide” is about encouraging healthy eating behavior. “You provide” means that the parent decides what foods to provide (the study provided hints on healthy, nutritious options), and “they decide” means the child chooses how much of that food to eat. cSleep problems were identifi ed by using a parental questionnaire. A sleep assessment was undertaken for those in the sleep or combination groups who identifi ed their child’s sleep as being a moderate to severe problem (for them) and requested assistance from the POI study. A personalized plan was then put in place. dAlthough the study contacted parents at 6, 12, and 18 months to assess sleep problems, parents could access the sleep problem intervention any time from 6 to 24 months’ postpartum by contacting the study.

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TAYLOR et al

life28 was measured in mothers and

partners when the child was 12

months of age.

Statistical Methods

The study was designed to have 80%

power to detect differences in BMI

of 0.5 at 2 years of age, assuming an

SD of 1.5, using a 2-sided test at the

0.05 level (n = 142 per arm), with

n = 800 in total after allowing for 25%

loss to follow-up. 18 Analyses were

designed to examine questions on

the effectiveness of the interventions

by using modified intention-to-

treat principles (all available data

were used for each analysis with

participants analyzed as per their

assigned group). Self-selected groups

(eg, those who chose to receive extra

sleep support) are not examined

here. Missing data were assumed

to be predominantly either missing

completely at random or missing

at random after conditioning on

stratification variables. All analyses

adjusted for the stratification

variables (ie, 3 levels of household

deprivation, 2 levels of parity).

Linear, mixed linear, mixed binary

logistic, mixed ordinal logistic,

and Cox’s proportional hazards

regression were used as indicated

in the tables. For outcomes

investigated at multiple times,

post hoc tests investigated group

differences for each time point only

if the overall test of group and the

group-by-time interaction were

statistically significant. If there was

evidence of group differences at any

particular time point, pairwise group

differences were then investigated

at that time point. For outcomes

with only 2 time points, models for

each time point were examined.

For continuous outcomes, in which

there was evidence of skew or

heteroscedasticity in model residuals,

natural log transformations were

investigated, with a constant of one

added if zeros were present. For

ordinal logistic regression models,

proportionality was examined

through comparison with generalized

ordinal logistic regression models.

The primary analyses compared the

4 groups with each other (control,

FAB, sleep, and combination). We

also conducted unplanned (data-

driven) exploratory comparisons

when the interaction term between

the sleep and FAB interventions

was not statistically significant (if

there was a lack of evidence that the

effect of sleep differed depending

on whether FAB was present, and

similarly for FAB). This approach

allowed us to estimate the effects of

the “sleep intervention” (ie, sleep and

combination compared with control

and FAB) and the “FAB intervention”

(ie, FAB and combination compared

with control and sleep). Details are

described in the Appendix.

Stata Release 13 (StataCorp,

College Station, TX) was used for all

analyses, with 2-sided P values < .05

considered statistically significant.

No formal adjustments were made

for multiple comparisons. However,

to avoid unduly inflating type I error

rates, individual tests for outcomes

investigated at multiple time points

were only performed if there were

statistically significant results for

prior tests (as described earlier).

Nevertheless, marginally significant

results should be interpreted with

caution.

RESULTS

We recruited 58.1% of those eligible

( Fig 2). Participants were older,

had less household deprivation,

and were more likely to identify as

European (all, P < .001) than women

who did not consent to participate.

Participants were mostly European

(85%), 48% were having their first

child, and 41% were overweight or

obese before pregnancy ( Table 1).

Retention was high at 2 years, and

women who remained were older,

less likely to be Māori or Pacific,

more highly educated, and from

less deprived households (all, P <

.05) but did not differ by maternal

prepregnancy BMI, parity, or infant

sex (all, P > .05). Attendance at

intervention sessions was high,

particularly during the first year:

95% to 96% of sleep intervention

participants received the 2 sleep

interventions, and 94% to 96%

of FAB intervention participants

received the antenatal session and

both lactation consultant visits.

Seventy-six percent to 90% of

participants attended the food and

activity sessions in year 1, with 66%

attending the final combined session

at 18 months.

There was no significant intervention

effect observed for BMI or BMI-for-

age z score at 24 months ( Table 2).

Although there was a group

difference in the prevalence of

obesity (overall, P = .027), this

outcome was driven by lower rates

of obesity in the sleep group (odds

ratio [OR], 0.46 [95% confidence

interval (CI), 0.25–0.83]; P = .011)

and the combination group (OR,

0.51 [95% CI, 0.28–0.90]; P = .022)

compared with the FAB group rather

than compared with the control

group. There was no evidence of an

interaction between the FAB and

sleep interventions (P = .755), and

an unplanned post hoc comparison

showed that the sleep intervention

(sleep and combination compared

with FAB and control) approximately

halved the odds of obesity (OR,

0.54 [95% CI, 0.35–0.82]; P = .004),

whereas there was no evidence of an

effect of the FAB intervention (FAB

and combination compared with

sleep and control: OR, 1.20 [95% CI,

0.80–1.81]; P = .385). Given chance

imbalances between intervention

groups, we repeated the analyses

adjusting for maternal BMI (both

continuous and categorical) and

found no meaningful change in

these results (results not shown).

As a further sensitivity analysis, in

response to the adverse direction of

the FAB group (ie, its significantly

higher risk of obesity compared with

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PEDIATRICS Volume 139 , number 3 , March 2017

the sleep group, reported earlier),

we excluded the FAB group entirely

from the model to examine whether

all those who received the sleep

intervention (sleep and combination

groups) differed from the control

group. This potentially conservative

estimate of the sleep effect was

diluted and no longer statistically

significant (OR, 0.61 [95% CI, 0.37–

1.01]; P = .054).

No intervention effect was observed

for the duration of exclusive

breastfeeding (P = .069) ( Table 3).

Exploratory analyses of exclusive

breastfeeding duration could not

be undertaken because there

was evidence of a statistically

significant interaction between the

sleep and FAB groups for at least

1 time point (P = .035). We have

previously reported that there were

no differences in food and nutrient

intake at 24 months. 20 There were

a few differences in activity-related

behaviors: children in the FAB and

combination groups spent more time

active outside than the control group

at 12 months (both, P ≤ .022), and

the amount of time spent watching

television was lower in the FAB

(P = .014) and combination (P < .001)

groups compared with the control

group at 6 months.

There was no evidence of a difference

in sleep duration, frequency of

waking at night, or prevalence of

sleep problems (all, P ≥ .187) ( Table

3). Although parental ratings of the

extent to which their infant’s sleep

was a problem differed between

groups (overall, P = .023), the only

difference was at 27 weeks (overall,

P = .042) with higher scores in

the FAB group compared with the

control group (P = .006). A 3-way

interaction involving time (P < .001)

precluded exploratory analyses of

sleep problems. There was also little

variation in child care practices

related to sleep, with similar

numbers in each group reporting

they put their child to bed when tired

but still awake (P = .537), did not

touch or hold their child to help them

go to sleep at night (both P ≥ .314),

or allowed the child to self-settle

without intervention (both, P > .059).

No significant differences in full or

any breastfeeding, family quality of

5

FIGURE 2Participant fl ow through the POI study to 24 months of age. The main analysis was completed as a 4-group comparison, and the exploratory analysis is illustrated by colored boxes. These indicate the pairs of groups that were combined to enable statistical analysis of the effects of the FAB and sleep interventions: blue refers to the “FAB intervention” comparisons, and green refers to the “sleep intervention” comparisons.

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TAYLOR et al

life, or the proportion of children

watching television were observed

(data not shown). Those in the sleep

or combination groups were more

likely to report receiving sleep advice

(P = .001) but not from nonstudy

sources (all overall P ≥ .054), nor

were there any group differences in

the usefulness of that advice (all, P

≥ .154). Although significant overall

group effects on weight (P = .037)

and length (P = .039) were observed

at 24 months, these changes were

relatively small (0.4 kg in weight;

0.7 cm in length).

6

TABLE 1 Infant, Maternal, and Family Characteristics at Baseline

Characteristic All (N = 802) Control Group

(n = 209)

FAB Group

(n = 205)

Sleep Group

(n = 192)

Combination Group

(n = 196)

Maternal age at child’s birth, y

Mean ± SD 31.6 ± 5.2 31.5 ± 5.0 32.1 ± 5.3 31.6 ± 5.2 31.0 ± 5.4

<25 92 (11.5) 23 (11.0) 19 (9.3) 22 (11.5) 28 (14.4)

25–33 442 (55.2) 121 (57.9) 109 (53.2) 103 (53.7) 109 (55.9)

34–43 262 (32.7) 64 (30.6) 75 (36.6) 65 (33.9) 58 (29.7)

≥44 5 (0.6) 1 (0.5) 2 (1.0) 2 (1.0) 0

Missing 1 0 0 0 1

Maternal ethnicity

New Zealand European 682 (85.7) 177 (84.7) 176 (86.3) 161 (83.8) 168 (85.7)

Māori 46 (5.7) 15 (7.2) 9 (4.4) 8 (4.2) 14 (7.1)

Pacifi c 13 (1.6) 2 (1.0) 3 (1.5) 4 (2.1) 4 (2.0)

Asian 39 (4.9) 9 (4.3) 9 (4.4) 14 (7.3) 7 (3.6)

MELAA 8 (1.0) 2 (1.0) 2 (1.0) 2 (1.0) 2 (1.0)

Other 13 (1.6) 4 (1.9) 5 (2.5) 3 (1.6) 1 (0.5)

Missing 1 0 1 0 0

Maternal parity (not including study child)

Primiparous 382 (47.6) 99 (47.4) 96 (46.8) 90 (46.9) 97 (49.5)

2–3 children 381 (47.5) 95 (45.5) 100 (48.8) 94 (49.0) 92 (46.9)

≥4 children 39 (4.9) 15 (7.2) 9 (4.4) 8 (4.2) 7 (3.6)

Maternal educationa

Year 11 or below 62 (7.8) 14 (6.8) 17 (8.4) 18 (9.4) 13 (6.7)

Year 12 or 13 131 (16.5) 41 (19.9) 23 (11.3) 30 (15.6) 37 (19.2)

Postsecondary qualifi cation 116 (14.6) 29 (14.1) 27 (13.3) 29 (15.1) 31 (16.1)

University degree or higher 485 (61.1) 122 (59.2) 136 (67.0) 115 (59.9) 112 (58.0)

Missing 8 3 2 0 3

Household deprivationb

1–3 (low) 276 (34.8) 74 (35.9) 70 (34.5) 65 (33.9) 67 (34.7)

4–7 350 (44.1) 93 (45.2) 86 (42.4) 84 (43.8) 87 (45.1)

8–10 (high) 168 (21.2) 39 (18.9) 47 (23.2) 43 (22.4) 39 (20.2)

Missing 8 3 2 0 3

Household income, NZ$

<20 000 25 (3.4) 6 (3.1) 5 (2.7) 5 (2.9) 9 (5.1)

20 000–40 000 87 (12.0) 29 (15.1) 20 (10.6) 17 (9.8) 21 (12.0)

40 000–70 000 210 (28.9) 65 (33.9) 43 (22.9) 50 (28.9) 52 (29.7)

≥70 000 406 (55.8) 92 (47.9) 120 (63.8) 101 (58.4) 93 (53.1)

Missing 74 17 17 19 21

Maternal prepregnancy BMI 25.1 ± 5.0 25.2 ± 5.0 25.4 ± 5.7 24.8 ± 4.4 24.9 ± 4.8

Maternal prepregnancy weight statusc

Underweight 20 (2.5) 9 (4.4) 3 (1.5) 4 (2.1) 4 (2.1)

Normal weight 448 (56.1) 113 (54.6) 114 (55.6) 104 (54.5) 117 (59.7)

Overweight 226 (28.3) 57 (27.5) 56 (27.3) 61 (31.9) 52 (26.5)

Obese 105 (13.1) 28 (13.5) 32 (15.6) 22 (11.6) 23 (11.7)

Missing 3 2 0 1 0

Infant sex

Female 391 (48.8) 111 (53.1) 98 (47.8) 82 (42.7) 100 (51.0)

Male 411 (51.3) 98 (46.9) 107 (52.2) 110 (57.3) 96 (49.0)

Infant birth weight, g

Mean ± SD 3551 ± 480 3522 ± 484 3561 ± 482 3595 ± 461 3529 ± 493

Missing 7 2 2 1 2

Data are presented as mean ± SD or n (%). MELAA = Middle Eastern, Latin American or African. a Secondary schooling in New Zealand is from year 9 to year 13 inclusive; postsecondary qualifi cations refer to all tertiary qualifi cations that are not university based.b Uses the New Zealand Index of Deprivation 2013, which combines 9 variables from the 2013 census and provides a deprivation score for each meshblock (ie, geographical units defi ned

by Statistics New Zealand containing ∼81 people). The score refl ects the extent of material and social deprivation and is used to construct deciles from 1 to 10.c Underweight is a BMI <18.5, normal weight is a BMI of 18.5 to <25.0, overweight is a BMI of 25.0 to <30.0, and obese is a BMI ≥30.

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PEDIATRICS Volume 139 , number 3 , March 2017

DISCUSSION

In this large randomized controlled

trial, advice and support on sleep,

nutrition, and physical activity

did not significantly affect BMI or

BMI z score at 2 years of age. The

unplanned secondary analysis,

however, suggested that those who

received the sleep intervention

(sleep and combination groups)

had a lower prevalence of obesity

than those who did not (control

and FAB groups). There were few

differences in behavioral variables

that might explain this reduced

obesity risk, including no discernible

effect on sleep duration, number

of awakenings, sleep problems, or

targeted sleep behaviors.

Despite a clear association between

short sleep duration and increased

obesity risk, 10 relatively few

interventions have been undertaken.

Slower infant weight gain was

reported after provision of parental

education regarding soothing sleep

strategies, 12, 14 and significant

differences in sleep duration and

BMI were observed in 2- to 5-year-

old children after the use of a

multifaceted intervention. 13 Two of

these studies were small; all included

other interventions in addition to

sleep and were relatively short (6–12

months), and 2 had no follow-up to

determine sustainability. A larger

sleep-only intervention reported

no significant differences in BMI at

6 years of age after use of a brief

intervention (1–3 visits) at 7 to 8

months of age.15 It is possible that

earlier intervention, such as in POI, is

required. Follow-up will determine

whether our intriguing, but

unplanned, results showing a positive

effect on obesity prevalence at age 2

years remain at 5 years of age.

It is difficult to explain how our sleep

intervention might influence obesity

if not via sleep duration, which did

not differ between groups. Although

questionnaires are not always in

agreement with actigraphic measures

of sleep, 29 these objective measures

also demonstrated no differences

in sleep duration. A major focus of

the present intervention was to help

the infant fall asleep when tired

without external aids. 30 Although

self-regulation is key to developing

healthy sleep–wake patterns 31 and is

related to body weight in children, 32

it is difficult to measure by using a

questionnaire. Our findings indicate

that similar numbers of children

were put to bed while awake but

tired across all groups, with few

parents touching their child to

encourage sleep or intervening

before the child self-settled if they

woke in the night. Stronger measures

of sleep-related self-regulation

include objective assessment via

video camera, which was not possible

in our large trial. However, several

well-validated measures of overall

self-regulation33 were included

in our follow-up measurements,

which might determine associations

between early self-regulation, sleep,

and growth.

We observed reduced television

viewing and greater outside active

play in the FAB and combination

groups, but these differences were

small and transient in nature. This

lack of effect on nutrition and activity

behaviors corresponds with other

studies demonstrating relatively few

behavioral changes and no effect

on BMI, 7, 8 with 1 exception. 6 This

latter study was undertaken in a

very disadvantaged area of Sydney,

Australia, whereas participants in the

other 3 studies were predominantly

well-educated, European women.

It is possible that POI participants

were receiving sufficient lifestyle

advice from their well-child care,

which diminished the potential to

alter behavior. However, the high

prevalence of overweight and obesity

in young New Zealand children

(29.6% at 2–4 years of age) 17

illustrates the urgent need

for additional assistance over

and above well-child care. Why it

appears to be so difficult to influence

nutrition20 or activity 34 behaviors

at this age is uncertain, but other

health priorities such as infant

crying 35 and sleep problems 36

may take precedence for parents.

It is also well recognized that

parents underestimate their

child’s weight status, 37 particularly

during infancy, 38 a time when

weight gain is often equated

with good parenting. 39 Such

misperception decreases the

likelihood of effective behavior

change in response to advice on diet

and activity. 37

The strengths of our study include

high retention and attendance

at intervention sessions, as well

7

TABLE 2 Anthropometric Outcomes at 24 Months of Age

Variable N All (N = 802) Control Group

(n = 209)

FAB Group

(n = 205)

Sleep Group

(n = 192)

Combination

Group

(n = 196)

Adjusted Pa

BMI 683 16.9 ± 1.3 16.9 ± 1.2 17.1 ± 1.4 16.8 ± 1.3 16.8 ± 1.3 .086

BMI-for-age z score 683 0.78 ± 0.90 0.77 ± 0.86 0.92 ± 0.96 0.68 ± 0.88 0.72 ± 0.87 .104

Child waist, cm 676 46.8 ± 2.9 46.7 ± 3.0 47.0 ± 3.0 46.6 ± 2.8 46.9 ± 2.8 .610

Prevalence of overweight (including obesity)b 683 273 (40.0) 68 (38.2) 73 (41.5) 61 (37.7) 70 (41.9) .770

Prevalence of obesity 683 114 (16.5) 33 (18.5)ab 40 (22.7)b 19 (11.7)a 21 (12.6)a .027

Data are presented as mean ± SD or n (%). Intervention group values on the same line with no superscript letters in common indicate signifi cant differences (P < .05) between groups.a All P values are from linear or logistic regression models and adjust for parity (primiparous and multiparous) and deprivation (NZ Deprivation deciles 1–3, 4–7, and 8–10) strata.b Prevalence of overweight (not including obesity was 16.7% in the control group, 19.1% in the FAB group, 21.9% in the sleep group, and 25.0% in the combination group.

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TAYLOR et al

as collection of outcome data by

measurers blinded to participant

group. Our study also has some

limitations. One-quarter of

participants did not complete the

24-month questionnaires, and

some demographic differences

were observed between those

retained and not retained at 2 years.

Questionnaires are less accurate

at assessing physical activity and

sleep behaviors than other methods

but were necessary for pragmatic

reasons. It is difficult to explain

why the sleep intervention affected

obesity but did not significantly

affect mean BMI. However, both

obesity and BMI are important

outcomes for successful population-

level obesity prevention when mean

BMI z scores are well above

zero, 25 as they are in New Zealand,

and our data suggest that the

patterns for BMI were similar

to those for obesity. Finally,

because our sample was relatively

socioeconomically advantaged, the

findings may be less applicable to

those living in more disadvantaged

circumstances.

8

TABLE 3 Behavioral Outcomes at 19 Weeks to 24 Months of Age

Variable Age N All (N = 802) Control

Group

(n = 209)

FAB Group

(n = 205)

Sleep Group

(n = 192)

Combination

Group

(n = 196)

Overall P

for Group

Differencea

P for

Specifi ed

Time

Exclusive breastfeeding, wk median

(IQR)b

778 15.0 (20.3) 14.5 (19.0) 13.0 (20.9) 14.0 (19.7) 17.0 (20.0) .069

Time in active play outside, median

(IQR), min/d

12 mo 644 20 (43) 20 (35)a 26 (51)a 20 (35)a 30 (50)a — .005

18 mo 557 30 (45) 30 (45) 30 (45) 30 (45) 40 (40) — .171

24 mo 467 40 (49) 40 (49) 35 (49) 39 (40) 45 (47) .045 .828

Time spent watching television;

geometric mean

(geometric SD), min/wkc

6 mo 217 111.3 (3.7) 162.1 (3.8)a 96.3 (3.5)ab 131.8 (3.5)ab 71.2 (3.7)a — <.001

12 mo 239 74.7 (3.3) 90.1 (3.5)a 70.3 (3.2)a 80.0 (3.1)a 57.8 (3.2)a — .046

18 mo 426 122.6 (3.4) 143.6 (3.3) 124.2 (3.5) 119.0 (3.3) 100.8 (3.6) — .191

24 mo 399 197.9 (3.1) 214.1 (3.4) 239.5 (2.6) 189.1 (3.1) 152.3 (3.2) .007 .118

Night sleep duration by

questionnaire, mean ± SD, h

19 wk 718 10.82 ± 1.38 10.88 ± 1.44 10.75 ± 1.27 10.75 ± 1.35 10.90 ± 1.47 — —

27 wk 700 11.08 ± 1.27 11.16 ± 1.33 11.00 ± 1.30 11.07 ± 1.17 11.10 ± 1.25 — —

12 mo 645 11.37 ± 0.89 11.46 ± 0.93 11.38 ± 0.92 11.33 ± 0.73 11.28 ± 0.94 — —

24 mo 510 11.20 ± 0.78 11.28 ± 0.87 11.18 ± 0.81 11.12 ± 0.71 11.19 ± 0.71 .907 —

Night sleep duration by

accelerometry, mean ± SD, h

24 mo 303 10.36 ± 0.90 10.31 ± 0.94 10.44 ± 0.86 10.43 ± 0.91 10.19 ± 0.91 .187 —

Night awakenings per week,

median category

19 wk 719 5–6 5–6 5–6 5–6 5–6 — —

27 wk 701 5–6 5–6 7 5–6 5–6 — —

12 mo 645 1–2 1–2 1–2 1–2 3–4 — —

24 mo 509 1–2 1–2 1–2 1–2 1–2 .451 —

Extent to which infants sleep was

a problem, d geometric mean

(geometric SD)

19 wk 719 2.14 (1.93) 2.03 (1.91) 2.29 (1.95) 2.23 (1.90) 2.01 (1.97) — .215

23 wk 685 2.20 (1.98) 2.15 (1.99) 2.36 (2.03) 2.16 (1.95) 2.13 (1.95) — .430

27 wk 702 2.39 (1.94) 2.21 (1.97)a 2.64 (1.89)a 2.45 (2.0)a 2.28 (1.91)a — .042

18 mo 609 1.90 (1.94) 2.01 (2.00) 1.92 (1.98) 1.73 (1.90) 1.92 (1.84) — .242

24 mo 510 1.83 (1.83) 1.94 (1.83) 1.83 (1.85) 1.67 (1.80) 1.86 (1.2) .023 .410

Sleep problems, e n (%) with score

of 5–8

19 wk 719 116 (16.1) 28 (14.4) 31 (17.1) 30 (17.5) 27 (15.7) — —

23 wk 685 135 (19.7) 33 (18.0) 43 (24.7) 31 (18.2) 28 (17.7) — —

27 wk 702 140 (19.9) 31 (16.6) 39 (21.4) 41 (24.6) 29 (17.5) — —

18 mo 609 87 (14.3) 32 (18.4) 25 (15.9) 17 (11.8) 13 (9.7) — —

24 mo 510 52 (10.2) 19 (13.5) 15 (10.9) 9 (7.9) 9 (7.6) .346 —

Frequency child put into bed when

tired but awakef

12 mo 646 1.6 (2.0) 1.5 (2.0) 1.7 (2.0) 1.6 (1.9) 1.6 (2.0) .537 —

Child falls asleep at night without

parent touching themf

12 mo 649 1.8 (2.1) 1.7 (2.1) 1.8 (2.1) 1.8 (2.1) 1.8 (2.2) .895 —

24 mo 511 1.5 (1.9) 0.4 (0.7) 0.4 (0.7) 0.3 (0.6) 0.5 (0.7) .314 —

Allowed child to self-settle without

intervention when

woke at night, n (%)

12 mo 499 70 (14.0) 21 (15.1) 25 (18.2) 6 (5.6) 18 (15.5) .059 —

24 mo 344 83 (24.1) 24 (25.8) 26 (27.1) 19 (26.0) 14 (17.1) .501 —

Data presented as indicated. Intervention group values on the same line with no superscript letters in common indicate signifi cant differences (P < .05) between groups. IQR, interquartile

range. —, not applicable.a P values are from Cox’s proportional hazards regression for exclusive breastfeeding duration, mixed linear models after a log-transformation for time in active play outside and time

spent watching television, mixed linear models for night sleep duration (both questionnaire and accelerometer obtained) and extent to which sleep was a problem, mixed ordinal logistic

models for number of night awakenings, mixed binary logistic models for sleep problems, and logistic regression for sleep behaviors (put to bed tired but awake, fall asleep without

parent touching them, allowed child to self-settle without intervention when woke at night). All analyses adjusted for parity (primiparous and multiparous) and deprivation (NZ Deprivation

deciles 1–3, 4–7, and 8–10) strata.b Medians and IQRs are for those with known (including zero) durations (n = 735).c Geometric mean and SD are calculated from back-transforming the mean calculated on the log scale.d From a possible score of 1 (no problem) to 8 (large problem).e A sleep problem was defi ned as having a score of 5 to 8 on this 8-point scale.f Where 1 = always, 4 = sometimes, and 7 = never presented as geometric mean (geometric SD).

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PEDIATRICS Volume 139 , number 3 , March 2017

CONCLUSIONS

The present nutrition and activity

intervention did not seem to affect

weight status in children at 2 years

of age. Exploratory analyses of the

brief sleep intervention (2 face-

to-face contacts, with additional

support if requested) suggest that

further research into more intensive

or longer sleep interventions is

justified. Future research should also

evaluate the potential for sleep to

affect growth in groups at higher risk

of obesity than was observed in our

well-educated, predominantly New

Zealand European population.

APPENDIX: EXPLORATORY ANALYSES

The primary analyses compared

the 4 groups with each other.

One of the study’s 4 groups (the

combination group) combined

both the sleep intervention and

the FAB intervention; the study

design can therefore also be seen

as a 2-by-2 factorial design with

an interaction. In effect, we had

2 groups being offered the “FAB

intervention” (FAB and combination)

and 2 groups being offered the

“sleep intervention” (sleep and

combination), doubling the number

of participants we could observe in

response to each intervention and

thus providing greater statistical

power to detect any effects as long

as there was no interaction between

the 2 interventions. An interaction

would mean that having both

interventions simultaneously (ie,

being in the combination group)

affected the response to the individual

approaches, and thus it would not be

appropriate to treat the combination

group as simply receiving the sum

of the FAB intervention and the

sleep intervention. The interaction

term between the sleep intervention

and the FAB intervention was used

to determine whether there was

evidence that the responses to these

2 interventions were not, in fact,

independent. The exploratory (data-

driven) comparisons were performed

by rerunning the model without the

interaction included (ie, a 2-by-2

factorial design without interaction),

with variables examining differences

between the groups receiving and not

receiving the sleep intervention (sleep

and combination) and between those

receiving and not receiving the FAB

intervention (FAB and combination)

included in the models ( Fig 2).

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9

ABBREVIATIONS

CI:  confidence interval

FAB:  food, activity, and

breastfeeding

OR:  odds ratio

POI:  Prevention of Overweight in

Infancy

This trial has been registered at www. clinicaltrials. gov (identifi er NCT00892983).

DOI: 10.1542/peds.2016-2037

Accepted for publication Dec 13, 2016

Address correspondence to Rachael Taylor, PhD, Department of Medicine, University of Otago, PO Box 56, Dunedin 9054, New Zealand. E-mail: rachael.taylor@

otago.ac.nz

PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).

Copyright © 2017 by the American Academy of Pediatrics

FINANCIAL DISCLOSURE: The authors have indicated they have no fi nancial relationships relevant to this article to disclose. The funders had no role in study

design, data collection and analysis, decision to publish, or preparation of the manuscript.

FUNDING: Funded by the Health Research Council of New Zealand (grant 08/374) and the Southern District Health Board. Dr Taylor is supported by the KPS

Fellowship in Early Childhood Obesity, and Dr Cameron was supported by the University of Otago, Health Sciences Postdoctoral Fellowship.

POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential confl icts of interest to disclose.

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