Three-year follow-up of a randomised controlled trial to reduce excessive weight gain in the first two years of life: protocol for the POI follow-up study.

BACKGROUND: The Prevention of Overweight in Infancy (POI) study was a four-arm randomised controlled trial (RCT) in 802 families which assessed whether additional education and support on sleep (Sleep group); food, physical activity and breastfeeding (FAB group); or both (Combination group), reduced excessive weight gain from birth to 2 years of age, compared to usual care (Control group). The study had high uptake at recruitment (58 %) and retention at 2 years (86 %). Although the FAB intervention produced no significant effect on BMI or weight status at 2 years, the odds of obesity were halved in those who received the sleep intervention, despite no apparent effect on sleep duration. We speculate that enhanced self-regulatory behaviours may exist in the Sleep group. Self-regulation was not measured in our initial intervention, but extensive measures have been included in this follow-up study. Thus, the overall aim of the POI follow-up is to determine the extent to which augmented parental support and education on infant sleep, feeding, diet, and physical activity in the first 2 years of life reduces BMI at 3.5 and 5 years of age, and to determine the role of self-regulation in any such relationship. METHODS/DESIGN: We will contact all 802 families and seek renewed consent to participate in the follow-up study. The families have received no POI intervention since the RCT finished at 2 years of age. Follow-up data collection will occur when the children are aged 3.5 and 5 years (i.e. up to 3 years post-intervention). Outcomes of interest include child anthropometry, body composition (DXA scan), diet (validated food frequency questionnaire), physical activity (accelerometry), sleep (questionnaire and accelerometry), and self-regulation (questionnaires and neuropsychological assessment). DISCUSSION: Our follow-up study has been designed primarily to enable us to determine whether the intriguing benefit of the sleep intervention suggested at 2 years of age remains as children approach school age. However, cohort analyses will also investigate how BMI, self-regulation, and sleep consolidation develop during the early years. This information will be valuable to researchers and policy makers progressing the field of early childhood obesity prevention. TRIAL REGISTRATION: ClinicalTrials.gov number NCT00892983 .

Lactation Consultant Support from Late Pregnancy with an Educational Intervention at 4 Months of Age Delays the Introduction of Complementary Foods in a Randomized Controlled Trial.

BACKGROUND: Although the WHO recommends that complementary feeding in infants should begin at 6 mo of age, it often begins before this in developed countries. OBJECTIVE: Our objective was to determine whether lactation consultant (LC) support, with educational resources given at 4-mo postpartum, can delay the introduction of complementary foods until around 6 mo of age. METHODS: A total of 802 mother-infant pairs were recruited from the single maternity hospital serving Dunedin, New Zealand (59% response rate) and randomly assigned to the following: 1) usual care (control group); 2) infant sleep education intervention (Sleep); 3) food, activity, and breastfeeding intervention (FAB); or 4) combination (both) intervention (Combo). Certified LCs delivered 3 intervention sessions (late pregnancy and 1-wk and 4-mo postpartum). The 4-mo contact used educational resources focused on developmental readiness for complementary foods. Age when complementary foods were introduced was obtained from repeated interviews (monthly from 3- to 27-wk postpartum). RESULTS: A total of 49.5% and 87.2% of infants received complementary foods before 5 and 6 mo of age, respectively. There was evidence of group differences in the number of infants introduced to complementary foods before 5 mo (P = 0.006), with those receiving support and resources (FAB and Combo groups combined; 55.6%) more likely to wait until at least 5 mo compared with controls (control and Sleep groups combined; 43.3%) (OR: 1.52; 95% CI: 1.08, 2.16). However, there was no evidence they were more likely to wait until 6 mo of age (P = 0.52). Higher maternal age, higher parity, and a less positive attitude toward breastfeeding were positively associated, and drinking alcohol during pregnancy was negatively associated, with later age of introduction of complementary foods. CONCLUSIONS: Providing an LC and educational resources at 4-mo postpartum to predominantly well-educated, mainly European, women can delay the introduction of complementary foods until 5 mo of age, but not until the WHO recommendation of 6 mo. This trial was registered at clinicaltrials.gov as NCT00892983.

Safe sleep practices in a New Zealand community and development of a Sudden Unexpected Death in Infancy (SUDI) risk assessment instrument.

BACKGROUND: Interventions to prevent sudden unexpected death in infancy (SUDI) have generally been population wide interventions instituted after case-control studies identified specific childcare practices associated with sudden death. While successful overall, in New Zealand (NZ), the rates are still relatively high by international comparison. This study aims to describe childcare practices related to SUDI prevention messages in a New Zealand community, and to develop and explore the utility of a risk assessment instrument based on international guidelines and evidence. METHODS: Prospective longitudinal study of 209 infants recruited antenatally. Participant characteristics and infant care data were collected by questionnaire at: baseline (third trimester), and monthly from infant age 3 weeks through 23 weeks. Published meta-analyses data were used to estimate individual risk ratios for 6 important SUDI risk factors which, when combined, yielded a "SUDI risk score". RESULTS: Most infants were at low risk for SUDI with 72% at the lowest or slightly elevated risk (combined risk ratio ≤1.5). There was a high prevalence of the safe practices: supine sleeping (86-89% over 3-19 weeks), mother not smoking (90-92% over 3-19 weeks), and not bed sharing at a young age (87% at 3 weeks). Five independent predictors of a high SUDI risk score were: higher parity (P =0.028), younger age (P =0.030), not working or caring for other children antenatally (P =0.031), higher depression scores antenatally (P =0.036), and lower education (P =0.042). CONCLUSIONS: Groups within the community identified as priorities for education about safe sleep practices beyond standard care are mothers who are young, have high parity, low educational levels, and have symptoms of depression antenatally. These findings emphasize the importance of addressing maternal depression as a modifiable risk factor in pregnancy.

Prevention of Overweight in Infancy (POI.nz) study: a randomised controlled trial of sleep, food and activity interventions for preventing overweight from birth.

BACKGROUND: Rapid weight gain during the first three years of life predicts child and adult obesity, and also later cardiovascular and other morbidities. Cross-sectional studies suggest that infant diet, activity and sleep are linked to excessive weight gain. As intervention for overweight children is difficult, the aim of the Prevention of Overweight in Infancy (POI.nz) study is to evaluate two primary prevention strategies during late pregnancy and early childhood that could be delivered separately or together as part of normal health care. METHODS/DESIGN: This four-arm randomised controlled trial is being conducted with 800 families recruited at booking in the only maternity unit in the city of Dunedin, New Zealand. Mothers are randomised during pregnancy to either a usual care group (7 core contacts with a provider of government funded "Well Child" care over 2 years) or to one of three intervention groups given education and support in addition to "Well Child" care: the Food, Activity and Breastfeeding group which receives 8 extra parent contacts over the first 2 years of life; the Sleep group which receives at least 3 extra parent contacts over the first 6 months of life with a focus on prevention of sleep problems and then active intervention if there is a sleep problem from 6 months to 2 years; or the Combination group which receives all extra contacts. The main outcome measures are conditional weight velocity (0-6, 6-12, 12-24 months) and body mass index z-score at 24 months, with secondary outcomes including sleep and physical activity (parent report, accelerometry), duration of breastfeeding, timing of introduction of solids, diet quality, and measures of family function and wellbeing (parental depression, child mindedness, discipline practices, family quality of life and health care use). This study will contribute to a prospective meta-analysis of early life obesity prevention studies in Australasia. DISCUSSION: Infancy is likely to be the most effective time to establish patterns of behaviour around food, activity and sleep that promote healthy child and adult weight. The POI.nz study will determine the extent to which sleep, food and activity interventions in infancy prevent the development of overweight. TRIAL REGISTRATION: Clinical Trials NCT00892983. Prospective meta-analysis registered on PROSPERO CRD420111188. Available from http://www.crd.york.ac.uk/PROSPERO.

Anticipatory guidance to prevent infant sleep problems within a randomised controlled trial: infant, maternal and partner outcomes at 6 months of age.

OBJECTIVE: To evaluate the effectiveness of sleep education delivered antenatally and at 3 weeks postpartum to prevent infant sleep problems at 6 months of age. DESIGN: Sleep intervention within a randomised controlled trial for the Prevention of Overweight in Infancy (POI) study. PARTICIPANTS: 802 families were randomly allocated to one of four groups: usual care (control), sleep intervention (sleep), food, activity and breastfeeding intervention (FAB), and combined group receiving both interventions (combination). INTERVENTIONS: All groups received standard Well Child care. The sleep intervention groups (sleep and combination) received an antenatal group education session (all mothers and most partners) emphasising infant self-settling and safe sleeping, and a home visit at 3 weeks reinforcing the antenatal sleep education. FAB and combination groups received four contacts providing education and support on breast feeding, food and activity up to 4 months postpartum. OUTCOME MEASURES: Here we report secondary sleep outcomes from the POI study: the prevalence of parent-reported infant sleep problems and night waking, and differences in sleep duration. Additional outcomes reported include differences in infant self-settling, safe sleep practices, and maternal and partner reports of their own sleep, fatigue and depression symptoms. RESULTS: Linear or mixed linear regression models found no significant intervention effects on sleep outcomes, with 19.1% of mothers and 16.6% of partners reporting their infant's sleep a problem at 6 months. Actigraphy estimated the number of night wakings to be significantly reduced (8%) and the duration of daytime sleep increased (6 min) in those groups receiving the sleep intervention compared with those who did not. However, these small differences were not clinically significant and not observed in 24 hours infant sleep diary data. No other differences were observed. CONCLUSION: A strategy delivering infant sleep education antenatally and at 3 weeks postpartum was not effective in preventing the development of parent-reported infant sleep problems.

Targeting Sleep, Food, and Activity in Infants for Obesity Prevention: An RCT.

OBJECTIVE: 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.

Heart rate variability and cardiac reflexes in small for gestational age infants.

To assess the influence of intrauterine growth retardation and postnatal development on heart rate variability (HRV) and cardiac reflexes, we studied 27 healthy small for gestational age (SGA) and 23 appropriate for gestational age (AGA) infants during a nap study. Resting HRV was assessed by point dispersion of Poincaré plots for overall (SDRR) and instantaneous beat-to-beat variability (SDDeltaRR) and the ratio (SDRR/SDDeltaRR). Heart rate reflex and arousal responses to a 60 degrees head-up tilt were determined. All tests/measures were repeated twice in quiet and active sleep and in prone and supine sleep positions at 1 and 3 mo of age. SGA infants exhibited higher resting sympathetic tone [SDRR/SDDeltaRR: 1.9 (95% confidence interval: 1.7, 2.0) and 1.7 (95% confidence interval: 1.5, 1.8) in SGA and AGA, respectively; P=0.046] and a tendency for a smaller tachycardic reflex response to the tilt [Deltaheart rate: 24 beats/min (95% confidence interval: 20, 28) and 30 (95% confidence interval: 25, 34)] in SGA and AGA, respectively; P=0.06]. HRV indexes were reduced in the prone compared with supine position (P<0.0001), but reflex tilt responses were unchanged with position. SGA/AGA differences were independent of sleep position. Gestational age weight status did not influence the likelihood of arousal, but prone sleeping per se reduced the odds 2.5-fold. The findings suggest reduced autonomic activity and cardiac reflexes in SGA infants. The finding that the sympathetic component of the control of HRV was higher in SGA infants could link with findings in adulthood of an association between being born SGA and a higher risk of cardiovascular disease.

Early Intervention to Encourage Physical Activity in Infants and Toddlers: A Randomized Controlled Trial.

INTRODUCTION: Few physical activity interventions have been undertaken in infants and toddlers, despite concerns that they are insufficiently active. The Prevention of Overweight in Infancy trial encouraged parents to be physically active with their child from birth, including prone-based play ("tummy time"), while reducing time spent restrained in car seats and "strollers." METHODS: A total of 802 women, recruited in late pregnancy, were randomized to a physical activity intervention, which provided information antenatally, and active group sessions with their infant at 3, 9, and 18 months of age. Questionnaires were completed at multiple time points, and toddlers wore Actical accelerometers for 5 d at 24 months of age. RESULTS: Attendance at intervention sessions was high in infancy but declined by 18 months to 66%. Almost all parents placed their infant prone to play at least once a day (90%-95%, overall median 25 min·d), with no intervention differences observed (P = 0.445 and P = 0.350 at 4 and 6 months, respectively). Few differences were observed in other measures of restraint or parental activity at any time point. At 2 yr, children spent approximately 8 h·d in sedentary time while awake and 3.6 h in light-to-vigorous activity. However, no group differences were apparent in counts per minute (P = 0.759) or time in light-to-vigorous activity (P = 0.960). CONCLUSION: An early life intervention targeting improvements in child and parent physical activity as part of a wider obesity prevention initiative had little effect on physical activity at 2 yr of age.

Impact of an early-life intervention on the nutrition behaviors of 2-y-old children: a randomized controlled trial.

BACKGROUND: Despite an extensive well-child health service, 30% of New Zealand's 2- to 4-y old children are overweight or obese. This suggests that additional intervention is necessary to establish healthy nutrition behaviors. OBJECTIVE: The aim of this study was to assess the effect of intervention from 0 to 18 mo of age on food and nutrient intake, eating behaviors, and parental feeding practices in 18- to 24-mo-old children. DESIGN: In total, 802 families with healthy infants were randomly allocated to 1 of 4 groups: Usual Care (UC); Food, Activity, and Breastfeeding (FAB); Sleep; or FAB and Sleep (Combination). All groups received standard "well-child" care. The FAB intervention comprised 7-8 additional contacts for education and support around breastfeeding, food, and activity. The Sleep intervention comprised 2 additional contacts for guidance about sleeping habits. Combination families received both interventions. A validated food-frequency questionnaire assessed food intake at 2 y. A questionnaire assessed eating behaviors and parental feeding practices at 18 and 24 mo. RESULTS: At 2 y, there were no statistically significant differences in food and nutrient intake or eating behaviors in the groups receiving the FAB intervention (FAB, Combination; 325 children) compared with the groups who did not (Sleep, UC; 341 children). With the use of a 5-point scale, small but statistically significant differences in parental feeding practices were observed in the groups receiving the FAB intervention: greater child control over eating (difference: 0.14; 95% CI: 0.02, 0.26) and less pressure to eat (difference: 0.18; 95% CI: 0.04, 0.32) at 18 mo, as well as greater encouragement of nutrient-dense foods at 24 mo (difference: 0.16; 95% CI: 0.03, 0.30). No statistically significant differences were observed between the groups who received the Sleep intervention (Sleep, Combination; 313 children) and those who did not, except higher meat intake in the former (11 g/d). CONCLUSION: Additional education and support for parents from birth did not improve nutrition behaviors in this population at 2 y of age. This trial was registered at clinicaltrials.gov as NCT00892983.

A matched case control study of orthostatic intolerance in children/adolescents with chronic fatigue syndrome.

This study aimed to define cardiovascular and heart rate variability (HRV) changes following head-up tilt (HUT) in children/adolescents with chronic fatigue syndrome (CFS) in comparison to age- and gender-matched controls. Twenty-six children/adolescents with CFS (11-19 y) and controls underwent 70-degree HUT for a maximum of 30 min, but returned to horizontal earlier at the participant's request with symptoms of orthostatic intolerance (OI) that included lightheadedness. Using electrocardiography and beat-beat finger blood pressure, a positive tilt was defined as OI with 1) neurally mediated hypotension (NMH); bradycardia (HR <75% of baseline), and hypotension [systolic pressure (SysP) drops >25 mm Hg)] or 2) postural orthostatic tachycardia syndrome (POTS); HR increase >30 bpm, or HR >120 bpm (with/without hypotension). Thirteen CFS and five controls exhibited OI generating a sensitivity and specificity for HUT of 50.0% and 80.8%, respectively. POTS without hypotension occurred in seven CFS subjects but no controls. POTS with hypotension and NMH occurred in both. Predominant sympathetic components to HRV on HUT were measured in CFS tilt-positive subjects. In conclusion, CFS subjects were more susceptible to OI than controls, the cardiovascular response predominantly manifest as POTS without hypotension, a response unique to CFS suggesting further investigation is warranted with respect to the pathophysiologic mechanisms involved.