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

Abstract

BackgroundBecause 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.Methods/Design316 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.DiscussionWith 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.Trial registrationNCT01167270. Registered 21 July 2010.

INSIGHT Responsive Parenting Intervention and Infant Sleep

“…The study design and inclusion/exclusion criteria have been published previously. 30 Major eligibility criteria included term singletons weighing ≥2500 g delivered to English-speaking, primiparous mothers ≥20 years old. Using a computer-generated algorithm, 291 dyads were randomized 2 weeks after delivery to the RP or control groups, stratified on birth weight for gestational age (<50th percentile or ≥50th percentile) and intended feeding mode (breastfeeding or formula).…”

“…As described previously, research nurses were trained in administering both the RP and control interventions 30 at home visits conducted at infant age 3–4, 16, 28, and 40 weeks, and a research center visit occurred at age 1 year. This study was approved by the Penn State College of Medicine’s Human Subjects Protection Office and registered at http://www.clinicaltrials.gov without sleep noted as an a priori outcome.…”

“…30 Lessons include instructing parents to (1) recognize infant hunger and satiety cues; (2) use alternatives to feeding to soothe a fussy, but nonhungry, infant; (3) provide appropriate portions of healthy foods and allow children to determine the amount consumed; (4) improve acceptance of developmentally appropriate foods such as vegetables through repeated exposure and positive role modeling, while discouraging controlling feeding practices; and (5) actively engage infants in playtime to reduce sedentary behaviors.…”

“…On the basis of previous research, 26–28 the sleep components focused on consolidating sleep and extending night sleep duration by providing guidance on sleep-related parenting behaviors, particularly establishing consistent bedtime routines, encouraging self-soothing and early bedtimes, and strategies to address night waking. 30 In this ongoing randomized, controlled trial, the RP intervention is compared with a home safety control intervention that includes a safe sleep component. We assessed intervention effects on infant sleep in the first year with the hypothesis that sleep duration would be longer and positive sleep-related behaviors would be more prevalent compared with controls.…”

Mother-Infant Room-Sharing and Sleep Outcomes in the INSIGHT Study

“…The study design and inclusion and exclusion criteria have been previously published. 26 Major eligibility criteria specified that the subjects be term singletons weighing ≥2500 g delivered to English-speaking, primiparous mothers ≥20 years old. Dyads were randomly assigned 2 weeks after delivery to a responsive parenting (RP) intervention or a safety control group.…”