Effect of a Responsive Parenting Educational Intervention on Childhood Weight Outcomes at 3 Years of Age: The INSIGHT Randomized Clinical Trial.

Importance: Rapid growth and elevated weight status in early childhood increase risk for later obesity, but interventions that improve growth trajectories are lacking. Objective: To examine effects of a responsive parenting intervention designed to promote developmentally appropriate, prompt, and contingent responses to a child's needs on weight outcomes at 3 years. Design, Setting, and Participants: A single-center randomized clinical trial comparing a responsive parenting intervention designed to prevent childhood obesity vs a home safety intervention (control) among 279 primiparous mother-child dyads (responsive parenting group, 140; control group, 139) who enrolled and completed the first home visit from January 2012 through March 2014 with follow-up to age 3 years (completed by April 2017). Interventions: Research nurses conducted 4 home visits during infancy and annual research center visits. The responsive parenting curriculum focused on feeding, sleep, interactive play, and emotion regulation. The control curriculum focused on safety. Main Outcomes and Measures: The primary outcome was body mass index (BMI) z score at 3 years (z score of 0 represents the population mean; 1 and -1 represent 1 SD above and below the mean, respectively). BMI percentile at 3 years was designated previously as the primary outcome. Secondary outcomes included the prevalence of overweight (BMI ≥85th percentile and <95th percentile) and obesity (BMI ≥95th percentile) at 3 years. Results: Among 291 mother-child dyads randomized, 279 received the first home visit and were included in the primary analysis. 232 mother-child dyads (83.2%) completed the 3-year trial. Mean age of the mothers was 28.7 years; 86% were white and 86% were privately insured. At age 3 years, children in the responsive parenting group had a lower mean BMI z score (-0.13 in the responsive parenting group vs 0.15 in the control group; absolute difference, -0.28 [95% CI, -0.53 to -0.01]; P = .04). Mean BMI percentiles did not differ significantly (47th in the responsive parenting group vs 54th in the control group; reduction in mean BMI percentiles of 6.9 percentile points [95% CI, -14.5 to 0.6]; P = .07). Of 116 children in the responsive parenting group, 13 (11.2%) were overweight vs 23 (19.8%) of 116 children in the control group (absolute difference, -8.6% [95% CI, -17.9% to 0.0%]; odds ratio [OR], 0.51 [95% CI, 0.25 to 1.06]; P = .07); 3 children (2.6%) in the responsive parenting group were obese vs 9 children (7.8%) in the control group (absolute difference, -5.2% [95% CI, -10.8% to 0.0%]; OR, 0.32 [95% CI, 0.08 to 1.20]; P = .09). Conclusions and Relevance: Among primiparous mother-child dyads, a responsive parenting intervention initiated in early infancy compared with a control intervention resulted in a modest reduction in BMI z scores at age 3 years, but no significant difference in BMI percentile. Further research is needed to determine the long-term effect of the intervention and assess its efficacy in other settings. Trial Registration: ClinicalTrials.gov Identifier: NCT01167270.

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

BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: NCT01167270. Registered 21 July 2010.

Advanced Health Information Technologies to Engage Parents, Clinicians, and Community Nutritionists in Coordinating Responsive Parenting Care: Descriptive Case Series of the Women, Infants, and Children Enhancements to Early Healthy Lifestyles for Baby (WEE Baby) Care Randomized Controlled Trial.

BACKGROUND: Socioeconomically disadvantaged newborns receive care from primary care providers (PCPs) and Women, Infants, and Children (WIC) nutritionists. However, care is not coordinated between these settings, which can result in conflicting messages. Stakeholders support an integrated approach that coordinates services between settings with care tailored to patient-centered needs. OBJECTIVE: This analysis describes the usability of advanced health information technologies aiming to engage parents in self-reporting parenting practices, integrate data into electronic health records to inform and facilitate documentation of provided responsive parenting (RP) care, and share data between settings to create opportunities to coordinate care between PCPs and WIC nutritionists. METHODS: Parents and newborns (dyads) who were eligible for WIC care and received pediatric care in a single health system were recruited and randomized to a RP intervention or control group. For the 6-month intervention, electronic systems were created to facilitate documentation, data sharing, and coordination of provided RP care. Prior to PCP visits, parents were prompted to respond to the Early Healthy Lifestyles (EHL) self-assessment tool to capture current RP practices. Responses were integrated into the electronic health record and shared with WIC. Documentation of RP care and an 80-character, free-text comment were shared between WIC and PCPs. A care coordination opportunity existed when the dyad attended a WIC visit and these data were available from the PCP, and vice versa. Care coordination was demonstrated when WIC or PCPs interacted with data and documented RP care provided at the visit. RESULTS: Dyads (N=131) attended 459 PCP (3.5, SD 1.0 per dyad) and 296 WIC (2.3, SD 1.0 per dyad) visits. Parents completed the EHL tool prior to 53.2% (244/459) of PCP visits (1.9, SD 1.2 per dyad), PCPs documented provided RP care at 35.3% (162/459) of visits, and data were shared with WIC following 100% (459/459) of PCP visits. A WIC visit followed a PCP visit 50.3% (231/459) of the time; thus, there were 1.8 (SD 0.8 per dyad) PCP to WIC care coordination opportunities. WIC coordinated care by documenting RP care at 66.7% (154/231) of opportunities (1.2, SD 0.9 per dyad). WIC visits were followed by a PCP visit 58.9% (116/197) of the time; thus, there were 0.9 (SD 0.8 per dyad) WIC to PCP care coordination opportunities. PCPs coordinated care by documenting RP care at 44.0% (51/116) of opportunities (0.4, SD 0.6 per dyad). CONCLUSIONS: Results support the usability of advanced health information technology strategies to collect patient-reported data and share these data between multiple providers. Although PCPs and WIC shared data, WIC nutritionists were more likely to use data and document RP care to coordinate care than PCPs. Variability in timing, sequence, and frequency of visits underscores the need for flexibility in pragmatic studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT03482908; https://clinicaltrials.gov/ct2/show/NCT03482908. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12887-018-1263-z.