Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Taylor BJ

PROVIDER: S-EPMC3293097 | biostudies-literature | 2011 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Taylor Barry J BJ Heath Anne-Louise M AL Galland Barbara C BC Gray Andrew R AR Lawrence Julie A JA Sayers Rachel M RM Dale Kelly K Coppell Kirsten J KJ Taylor Rachael W RW

BMC public health 20111219

<h4>Background</h4>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 delivere ...[more]

PMID: 22182309

Similar Datasets

Project description:ObjectivesWe report on the acceptability, feasibility, dose-response relationship and adherence of two nutritional strategies to improve mood (multinutrient supplements; food-related behavioural activation (F-BA)) studied in a randomised controlled depression prevention trial (the Multi-country cOllaborative project on the rOle of Diet, Food-related behaviour, and Obesity in the prevention of Depression (MooDFOOD) Trial). We also assessed baseline determinants of adherence and assessed whether better adherence resulted in lower depressive symptoms.DesignRandomised controlled trial with a 2×2 factorial design conducted between 2015 and 2017.SettingGermany, the Netherlands, UK and Spain.ParticipantsCommunity sample of 1025 overweight adults with elevated depressive symptoms without a current episode of major depressive disorder. Main eligibility criteria included age (18-75 years), being overweight or obese, and having at least mild depressive symptoms, shown by a Patient Health Questionnaire Score of ≥5. A total of 76% of the sample was retained at the 12-month follow-up.InterventionsDaily nutritional supplements versus pill placebo or an F-BA therapy, delivered in individual and group sessions versus no behavioural intervention over a 1-year period.Primary and secondary outcome measuresPrimary outcome: self-reported acceptability of the interventions.Secondary outcomesadherence and self-reported depressive symptoms.ResultsMost participants reported that the F-BA was acceptable (83.61%), feasible to do (65.91%) and would recommend it to a friend (84.57%). Individual F-BA sessions (88.10%) were significantly more often rated as positive than group F-BA sessions (70.17%) and supplements (28.59%). There were statistically significant reductions in depressive symptoms for those who both adhered to the F-BA intervention and had a history of depression (B=-0.08, SE=0.03, p=0.012) versus those who had no history of depression. Supplement intake had no effect on depressive symptoms irrespective of adherence.ConclusionsF-BA may have scope for development as a depression prevention intervention and public health strategy but further refinement and testing are needed.Trial registration numberNCT02529423.

Project description:BackgroundSkin barrier dysfunction precedes eczema development. We tested whether daily use of emollient in the first year could prevent eczema in high-risk children.MethodsWe did a multicentre, pragmatic, parallel-group, randomised controlled trial in 12 hospitals and four primary care sites across the UK. Families were approached via antenatal or postnatal services for recruitment of term infants (at least 37 weeks' gestation) at high risk of developing eczema (ie, at least one first-degree relative with parent-reported eczema, allergic rhinitis, or asthma, diagnosed by a doctor). Term newborns with a family history of atopic disease were randomly assigned (1:1) to application of emollient daily (either Diprobase cream or DoubleBase gel) for the first year plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). The randomisation schedule was created using computer-generated code (stratified by recruiting centre and number of first-degree relatives with atopic disease) and participants were assigned to groups using an internet-based randomisation system. The primary outcome was eczema at age 2 years (defined by UK working party criteria) with analysis as randomised regardless of adherence to allocation for participants with outcome data collected, and adjusting for stratification variables. This trial is registered with ISRCTN, ISRCTN21528841. Data collection for long-term follow-up is ongoing, but the trial is closed to recruitment.Findings1394 newborns were randomly assigned to study groups between Nov 19, 2014, and Nov 18, 2016; 693 were assigned to the emollient group and 701 to the control group. Adherence in the emollient group was 88% (466 of 532) at 3 months, 82% (427 of 519) at 6 months, and 74% (375 of 506) at 12 months in those with complete questionnaire data. At age 2 years, eczema was present in 139 (23%) of 598 infants with outcome data collected in the emollient group and 150 (25%) of 612 infants in the control group (adjusted relative risk 0·95 [95% CI 0·78 to 1·16], p=0·61; adjusted risk difference -1·2% [-5·9 to 3·6]). Other eczema definitions supported the results of the primary analysis. Mean number of skin infections per child in year 1 was 0·23 (SD 0·68) in the emollient group versus 0·15 (0·46) in the control group; adjusted incidence rate ratio 1·55 (95% CI 1·15 to 2·09).InterpretationWe found no evidence that daily emollient during the first year of life prevents eczema in high-risk children and some evidence to suggest an increased risk of skin infections. Our study shows that families with eczema, asthma, or allergic rhinitis should not use daily emollients to try and prevent eczema in their newborn.FundingNational Institute for Health Research Health Technology Assessment.

Project description:BackgroundGestational Diabetes Mellitus (GDM) has well recognised adverse health implications for the mother and her newborn that are both short and long term. Obesity is a significant risk factor for developing GDM and the prevalence of obesity is increasing globally. It is a matter of public health importance that clinicians have evidence based strategies to inform practice and currently there is insufficient evidence regarding the impact of dietary and lifestyle interventions on improving maternal and newborn outcomes. The primary aim of this study is to measure the impact of a telephone based intervention that promotes positive lifestyle modifications on the incidence of GDM. Secondary aims include: the impact on gestational weight gain; large for gestational age babies; differences in blood glucose levels taken at the Oral Glucose Tolerance Test (OGTT) and selected factors relating to self-efficacy and psychological wellbeing.Method/designA randomised controlled trial (RCT) will be conducted involving pregnant women who are overweight (BMI >25 to 29.9 k/gm2) or obese (BMI >30 kgm/2), less than 14 weeks gestation and recruited from the Barwon South West region of Victoria, Australia. From recruitment until birth, women in the intervention group will receive a program informed by the Theory of Self-efficacy and employing Motivational Interviewing. Brief ( less than 5 minute) phone contact will alternate with a text message/email and will involve goal setting, behaviour change reinforcement with weekly weighing and charting, and the provision of health information. Those in the control group will receive usual care. Data for primary and secondary outcomes will be collected from medical record review and a questionnaire at 36 weeks gestation.DiscussionEvidence based strategies that reduce the incidence of GDM are a priority for contemporary maternity care. Changing health behaviours is a complex undertaking and trialling a composite intervention that can be adopted in various primary health settings is required so women can be accessed as early in pregnancy as possible. Using a sound theoretical base to inform such an intervention will add depth to our understanding of this approach and to the interpretation of results, contributing to the evidence base for practice and policy.Trial registrationThis trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000125729.

Project description:BackgroundPremature birth rates have slightly increased globally, making its prevention critical for both short-term and long-term health outcomes. Various interventions have been developed in response to the multifaceted risk factors for premature birth, including internet-based programs. These programs offer accessibility and enhanced engagement; however, their overall efficacy in preventing premature births requires thorough evaluation.ObjectiveThis systematic review aims to identify the study designs and assess the effectiveness of internet-based interventions in preventing premature birth among pregnant women.MethodsA comprehensive search of the MEDLINE, Embase, CINAHL, and Cochrane Library databases was conducted to identify randomized trials and quasi-experimental studies evaluating internet-based interventions for premature birth prevention in pregnant women. The search was inclusive, with no restrictions based on language or geographical location, allowing for a comprehensive global perspective. The time frame for the inclusion of studies extended until February 2023. The risk of bias (RoB) in each study was independently assessed by 3 authors forming pairs, using the revised Cochrane RoB tool (RoB 2) for randomized trials, as per the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Owing to heterogeneity in populations, measurements, and interventions, a meta-analysis was not conducted.ResultsThis review included 26 articles, comprising 12 intention-to-treat and 14 per-protocol studies. The overall RoB was high in most intention-to-treat studies and of some concern in most per-protocol studies. The target populations varied, including nonspecific pregnant women, those with gestational diabetes mellitus (GDM) or those at risk of GDM, individuals with anxiety or depression, and those experiencing preterm labor. Psychosocial, physiological, and wellness health outcomes were evaluated. Internet-based interventions effectively reduced stress/distress in nonspecific pregnant women but not in those experiencing preterm labor. Their effectiveness in reducing anxiety and depression varied, with inconsistent results among different groups. In women with GDM or those at risk of GDM, interventions successfully controlled fasting plasma glucose and 2-hour postprandial plasma glucose levels but did not consistently manage glycated hemoglobin levels. These interventions did not reduce the incidence of premature births across the various populations studied. The effectiveness of these internet-based interventions in addressing substance or alcohol abuse and insomnia also varied.ConclusionsInternet-based interventions show promise in improving psychosocial health and managing blood sugar to prevent premature birth, highlighting variability in effectiveness across different risk factors. Further research, including clinical trials, is vital for developing, evaluating, and disseminating effective, safe internet-based interventions. Establishing standardized measurement tools and rigorous evaluation processes is crucial for enhancing these interventions' effectiveness and reliability in clinical practice, significantly contributing to preventing premature births and improving maternal health outcomes.Trial registrationPROSPERO CRD42021278847; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021278847.

Project description:BackgroundThe Prevention of Overweight in Infancy (POI) randomized controlled trial assessed the effect of a more conventional food, physical activity, and breastfeeding intervention, with a more novel sleep intervention on weight outcomes at 2 years of age. The trial had 58% uptake at recruitment, and retention was 86% at age 2 years, 77% at age 3.5 years, and 69% at age 5 years. Children who received the brief sleep intervention in infancy had just half the risk of obesity at 2 years of age compared to those who did not receive the sleep intervention. Importantly, this substantially reduced risk was still apparent at our follow-up at 5 years of age.ObjectiveThe primary aim of this follow-up at age 11 years is to determine whether differences in BMI z-score and obesity risk remain apparent now that it is at least 9 years since cessation of the sleep intervention. Several secondary outcomes of interest will also be examined including 24-hour movement patterns, mental health and wellbeing, and use of electronic media, particularly prior to sleep.MethodsWe will seek renewed consent from all 734 of the original 802 POI families who expressed interest in further involvement. Children and parent(s) will attend 2 clinics and 1 home appointment to obtain measures of anthropometry and body composition (dual-energy x-ray absorptiometry scan), 24-hour movement patterns (sleep, sedentary time, and physical activity measured using an AX3 accelerometer), mental health and wellbeing (validated questionnaires), family functioning (validated questionnaires), use of electronic media (wearable and stationary cameras, questionnaires), and diet and eating behaviors (24-hour recall, questionnaires).ResultsThis follow-up study has full ethical approval from the University of Otago Human Ethics Committee (H19/109) and was funded in May 2019 by the Health Research Council of New Zealand (grant 19/346). Data collection commenced in June 2020, and first results are expected to be submitted for publication in 2022.ConclusionsLong-term outcomes of early obesity intervention are rare. Despite the growing body of evidence linking insufficient sleep with an increased risk of obesity in children, interventions targeting improvements in sleep have been insufficiently explored. Our initial follow-up at 5 years of age suggested that an early sleep intervention may have long-term benefits for effective weight management in children. Further analysis in our now preteen population will provide much-needed evidence regarding the long-term effectiveness of sleep interventions in infancy as an obesity prevention approach.Trial registrationClinicalTrials.gov NCT00892983; https://tinyurl.com/y3xepvxf.International registered report identifier (irrid)DERR1-10.2196/24968.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets