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The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study.

ABSTRACT: Because early life growth has long-lasting metabolic and behavioral consequences, intervention during this period of developmental plasticity may alter long-term obesity risk. While modifiable factors during infancy have been identified, until recently, preventive interventions had not been tested. The Intervention Nurses Starting Infants Growing on Healthy Trajectories (INSIGHT). Study is a longitudinal, randomized, controlled trial evaluating a responsive parenting intervention designed for the primary prevention of obesity. This "parenting" intervention is being compared with a home safety control among first-born infants and their parents. INSIGHT's central hypothesis is that responsive parenting and specifically responsive feeding promotes self-regulation and shared parent-child responsibility for feeding, reducing subsequent risk for overeating and overweight.316 first-time mothers and their full-term newborns were enrolled from one maternity ward. Two weeks following delivery, dyads were randomly assigned to the "parenting" or "safety" groups. Subsequently, research nurses conduct study visits for both groups consisting of home visits at infant age 3-4, 16, 28, and 40 weeks, followed by annual clinic-based visits at 1, 2, and 3 years. Both groups receive intervention components framed around four behavior states: Sleeping, Fussy, Alert and Calm, and Drowsy. The main study outcome is BMI z-score at age 3 years; additional outcomes include those related to patterns of infant weight gain, infant sleep hygiene and duration, maternal responsiveness and soothing strategies for infant/toddler distress and fussiness, maternal feeding style and infant dietary content and physical activity. Maternal outcomes related to weight status, diet, mental health, and parenting sense of competence are being collected. Infant temperament will be explored as a moderator of parenting effects, and blood is collected to obtain genetic predictors of weight status. Finally, second-born siblings of INSIGHT participants will be enrolled in an observation-only study to explore parenting differences between siblings, their effect on weight outcomes, and carryover effects of INSIGHT interventions to subsequent siblings.With increasing evidence suggesting the importance of early life experiences on long-term health trajectories, the INSIGHT trial has the ability to inform future obesity prevention efforts in clinical settings.NCT01167270. Registered 21 July 2010.

SUBMITTER: Paul IM

PROVIDER: S-EPMC4105401 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

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Project description:BackgroundAlthough previous work has shown that children with older siblings tend to have poorer diet quality, no study has directly compared diets of infant siblings.ObjectiveThe goals of this analysis were to examine birth-order differences in dietary intake between firstborn (FB) and secondborn (SB) siblings, and to determine whether a responsive parenting (RP) intervention modified birth-order effects on diet.MethodsThe Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study randomly assigned first-time mothers to an RP intervention, which included guidance on feeding, sleep, soothing, and interactive play, or control. INSIGHT mothers who delivered a second child enrolled in an observation-only study of their SB infant (SIBSIGHT). Mothers completed FFQs for both children at ages 6 (n = 97 sibling pairs) and 12 (n = 100) mo. FB compared with SB intake of food groups of interest were compared, and the moderating effect of the RP intervention on birth-order differences was tested using generalized linear mixed models.ResultsThough FBs and SBs had similar diets, more FBs than SBs consumed 100% fruit juice at both 6 (13.8 compared with 3.2%, P = 0.006) and 12 mo (46.0 compared with 32.0%, P = 0.01). SBs consumed fruit more frequently (FB 2.8 compared with SB 3.2 times/d, P = 0.01), and were more likely to consume fried potatoes (FB 38.4 compared with SB 57.6%, P = 0.0009) and processed meats (FB 43.0 compared with SB 58.0%, P = 0.02) than FBs at 12 mo. There were no differences by birth order in intake of sweets, snacks, or sugar-sweetened beverages at 12 mo. At 12 mo, RP-group SBs ate vegetables more times per day (3.2) than control SBs (2.2, P = 0.01). RP-SBs also consumed a greater variety of vegetables (10.2) than control-SBs (7.9, P = 0.01).ConclusionsBirth order is not consistently associated with healthy or unhealthy infant dietary intake. However, an RP intervention delivered to first-time mothers may benefit subsequent infants' vegetable intake. This trial was registered at clinicaltrials.gov as NCT01167270.

Project description:Nearly one in five 4-year-old children in the United States are obese, with low-income children almost twice as likely to be obese as their middle/upper-income peers. Few obesity prevention programs for low-income preschoolers and their parents have been rigorously tested, and effects are modest. We are testing a novel obesity prevention program for low-income preschoolers built on the premise that children who are better able to self-regulate in the face of psychosocial stressors may be less likely to eat impulsively in response to stress. Enhancing behavioral self-regulation skills in low-income children may be a unique and important intervention approach to prevent childhood obesity.The Growing Healthy study is a randomized controlled trial evaluating two obesity prevention interventions in 600 low-income preschoolers attending Head Start, a federally-funded preschool program for low-income children. Interventions are delivered by community-based, nutrition-education staff partnering with Head Start. The first intervention (n?=?200), Preschool Obesity Prevention Series (POPS), addresses evidence-based obesity prevention behaviors for preschool-aged children and their parents. The second intervention (n?=?200) comprises POPS in combination with the Incredible Years Series (IYS), an evidence-based approach to improving self-regulation among preschool-aged children. The comparison condition (n?=?200) is Usual Head Start Exposure. We hypothesize that POPS will yield positive effects compared to Usual Head Start, and that the combined intervention (POPS?+?IYS) addressing behaviors well-known to be associated with obesity risk, as well as self-regulatory capacity, will be most effective in preventing excessive increases in child adiposity indices (body mass index, skinfold thickness). We will evaluate additional child outcomes using parent and teacher reports and direct assessments of food-related self-regulation. We will also gather process data on intervention implementation, including fidelity, attendance, engagement, and satisfaction.The Growing Healthy study will shed light on associations between self-regulation skills and obesity risk in low-income preschoolers. If the project is effective in preventing obesity, results can also provide critical insights into how best to deliver obesity prevention programming to parents and children in a community-based setting like Head Start in order to promote better health among at-risk children.Clinicaltrials.gov Identifier: NCT01398358.

Project description:IntroductionThe Healthy Life Trajectories Initiative is an international consortium comprising four harmonised but independently powered trials to evaluate whether an integrated intervention starting preconceptionally will reduce non-communicable disease risk in their children. This paper describes the protocol of the India study.Methods and analysisThe study set in rural Mysore will recruit ~6000 married women over the age of 18 years. The village-based cluster randomised design has three arms (preconception, pregnancy and control; 35 villages per arm). The longitudinal multifaceted intervention package will be delivered by community health workers and comprise: (1) measures to optimise nutrition; (2) a group parenting programme integrated with cognitive-behavioral therapy; (3) a lifestyle behaviour change intervention to support women to achieve a diverse diet, exclusive breast feeding for the first 6 months, timely introduction of diverse and nutritious infant weaning foods, and adopt appropriate hygiene measures; and (4) the reduction of environmental pollution focusing on indoor air pollution and toxin avoidance.The primary outcome is adiposity in children at age 5 years, measured by fat mass index. We will report on a host of intermediate and process outcomes. We will collect a range of biospecimens including blood, urine, stool and saliva from the mothers, as well as umbilical cord blood, placenta and specimens from the offspring.An intention-to-treat analysis will be adopted to assess the effect of interventions on outcomes. We will also undertake process and economic evaluations to determine scalability and public health translation.Ethics and disseminationThe study has been approved by the institutional ethics committee of the lead institute. Findings will be published in peer-reviewed journals. We will interact with policy makers at local, national and international agencies to enable translation. We will also share the findings with the participants and local community through community meetings, newsletters and local radio.Trial registration numberISRCTN20161479, CTRI/2020/12/030134; Pre-results.

Project description:BackgroundPrevention of childhood obesity is a key approach to the primary prevention of noncommunicable diseases. Several models, based on the population health approach and aligned with ecological models, are used to design childhood obesity prevention programs around the world.ObjectiveThis study aims to introduce the design and evaluation plan of "Iran Healthy Start (IHS)/Aghazi Salem, Koodake Irani"-the customized Iranian version of Canadian Healthy Start/Départ Santé health promotion program-which is now being developed in Mashhad University of Medical Sciences (Mashhad, Iran) and focuses on improving physical activity and healthy eating among preschool children.MethodsWe will evaluate the intervention using a pilot randomized controlled design. The components of intervention include customized Decoda Web-based resources for children, an implementation guide for educators and managers, training and monitoring, communication and knowledge exchange, building partnership, and parent engagement. Outcomes include changes in anthropometry, physical activity level, nutritional risk status and dietary intake, and quality of life.ResultsThe project is funded by Mashhad University of Medical Sciences. The intervention was completed by the end of March 2018, and the analysis is currently under way. The first results of the IHS intervention program are expected to be submitted for publication in December 2018.ConclusionsThe double burden of malnutrition in early years children is a major health concern in developing countries. This justifies the need for health promotion programs that are specifically designed to target both overnutrition and undernutrition prevention. If the efficacy approved, the IHS could potentially be a comprehensive health promotion program for young children whose lifestyle behaviors can be improved toward a healthy future life in a nutrition transition setting.Trial registrationInternational Clinical Trials Registry Platform IRCT2016041927475N1; https://en.irct.ir/trial/22497.International registered report identifier (irrid)RR1-10.2196/11329.

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The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study.

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