Teaching Healthy Responsive Parenting During Infancy to Promote Vital Growth and dEvelopment (THRIVE) Study
Condition: Parenting; Feeding Behavior; Sleep; Parent-Child Relations
Study type: Interventional

Summary: 
      Background. Unprecedented rates of overweight and obesity are seen in childhood1 with
      evidence suggesting that infancy may be a critical period for the development of this high
      weight trajectory. This has led to a call for proposals for "understanding factors in infancy
      and early childhood (birth to 24 months) that influence obesity development (PA-18-032)."
      Objectives. The current study seeks to recruit a sample of mother-infant dyads to pilot a
      responsive parenting focused obesity prevention program delivered by behavior and development
      specialists in pediatric primary care. Methods. Approximately 80 mother-infant dyads will be
      recruited in pediatric primary care at their newborn visit and randomly assigned to one of
      two groups: a) Healthy Growth (new intervention) or b) Healthy Steps (as usual). We will
      obtain assessments of growth, feeding, and sleep throughout the study period for infants
      across five clinic visits and at-home measure completion. Research clinic visits will take
      place at their regularly scheduled well-child check visits at ages 1, 2, 4, and 6 mos and
      in-home measures will be completed monthly. The intervention program is hypothesized to show
      efficacy in both breast and formula fed infants as measured by the primary (i.e., BMI
      percentile and BMI z-score) and secondary outcomes (e.g., awareness of infant cues, use of
      alternative soothing strategies, when it is not time for a feeding).
    

Detailed description: 
      PURPOSE OF STUDY AND OBJECTIVES

      This study seeks to pilot deliver an early obesity prevention program in pediatric primary
      care that has been previously found efficacious when delivered via home visits. Modeled after
      the principles of the INSIGHT study, (cite) it uses a responsive parenting framework and
      provides developmentally tailored feeding, sleeping, and soothing guidance to parents of
      infants. Given its efficacy when delivered during home visits, study investigators aim to
      examine whether it can be adapted and delivered as part of the prevention work in integrated
      behavioral health (IBH) primary care practices. Currently, the integrated behavioral health
      model for prevention work follows the Healthy Steps program. Study investigators aim to
      compare these two prevention programs to examine if Teaching Healthy Responsive Parenting in
      Infancy to promote Vital growth and dEvelopment (THRIVE) improves outcomes (i.e., rapid
      weight gain, soothing, feeding, and sleep) above and beyond seeing a psychologist in a less
      focused way (Healthy Steps). The intervention will be delivered to 40 families by
      postdoctoral psychology fellows integrated in a pediatric primary care setting at each infant
      well-child check (WCC) visit during the first 6 months of life (e.g., 1, 2, 4, 6 mos), while
      another 40 families will receive care as usual (Healthy Steps) at each WCC during the first 6
      months and constitute our control group. The THRIVE program aims to prevent rapid weight gain
      in infancy, as well as establish healthy eating, sleeping, and self-regulation habits early
      on in life, by teaching parents responsive parenting principles. More specific portions of
      the intervention will instruct parents a) to recognize infant hunger and satiety cues and use
      feeding more selectively in response to hunger only, b) to recognize other reasons for crying
      or fussy behavior and use alternative soothing strategies when these other reasons apply, c)
      how to lay the foundation for healthy infant sleep and respond to nighttime awakenings to
      promote self-soothing, and d) how to introduce complimentary foods at 6 mos, provide repeated
      exposure to a variety of healthy foods using positive role modeling, and allow infants to
      determine the amount consumed. In the current study, study investigators have proposed the
      following aims and hypotheses:

      Primary Aims. To develop and pilot an obesity prevention program to be delivered in pediatric
      primary care at each infant well-child check (WCC) throughout the first 6 months (e.g., 1, 2,
      4, 6 mos) and continue to follow families for assessment throughout the first year of life
      (e.g., follow-up at 9 mos). To evaluate the efficacy/magnitude of effect, feasibility, and
      acceptability of an individually-tailored, responsive parenting prevention intervention on
      parent's ability to 1) use alternative strategies to soothe their infant (besides feeding)
      and to 2) increase their responsive parenting skills, such as attunement, awareness of infant
      cues (hunger, satiety, sleepy, other fussiness), and responsive feeding from those in the
      control condition (Healthy Steps).

      Primary Aim 1. To evaluate the feasibility of recruitment and retention of mother-infant
      dyads in primary care and refine assessment procedures to inform the design of an anticipated
      K23 application.

      H1: The intervention format will demonstrate feasibility and acceptability via intervention
      session attendance and parent report.

      Primary Aim 2. To examine if parents' strategies to soothe, feed, and put to sleep their
      infants differ between those in the intervention arm (THRIVE) compared to the control group
      (Healthy Steps).

      H2a: Parents in the THRIVE group will demonstrate less frequent use of food to soothe infants
      and a greater use of a variety of other alternative soothing strategies when infant is not
      hungry.

      H2b: Parents in the THRIVE group will report greater attunement, awareness of infant hunger
      and satiety cues, and responsive feeding.

      Exploratory Aim. To examine weight trajectories of infants and estimate effect sizes to
      detect the relationship between sleep and feeding patterns. Infant anthropometrics will be
      assessed at ages 1, 2, 4, 6, and 9 mos with growth metrics derived based on US population
      references.3 H3: Infants in the THRIVE intervention will experience less rapid weight gain
      compared to infants in the control condition from birth - 9 months.
    

Intervention name(s): THRIVE intervention; Active Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Parents learn responsive parenting skills, such as a) recognizing infant hunger and satiety cues and using feeding more selectively in response to hunger only, b) recognizing other reasons for crying or fussy behavior and using alternative soothing strategies when these other reasons apply, c) learning to lay the foundation for healthy infant sleep and respond to nighttime awakenings to promote self-soothing, and d) learning to introduce complimentary foods at 6 months, provide repeated exposure to a variety of healthy foods using positive role modeling, and allow infants to determine the amount consumed.; Parents learn about development, safety, and positive parenting without a specific emphasis on feeding, sleep, and soothing.
Other intervention name(s): responsive parenting; Care as Usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention