Clinical trial NCT05781100: Investigating Baby Behavior and Family Technology Use Study
Official title: Maternal Technology Use During Feeding and Infant Self-Regulation and Growth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mobile Phone Use
Mother-Infant Interaction
Infant Development
Self-Regulation, Emotion
Self-Regulation
Lead sponsor: California Polytechnic State University-San Luis Obispo
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Parkview Health
First posted: 2023-03-23
Enrollment: 345
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: To assess effects of maternal technology use on infant feeding interactions at 2wk and 4mo, mother-infant dyads will be observed during 3 different feeding conditions counterbalanced across 3 days:

TV Use condition: Mothers will be asked to watch a 22-minute long TV show on a large tablet while they feed their infants. Mothers will choose from four preselected episodes of popular sitcoms. The show will be stopped when the mother indicates she is done feeding her infant.

Mobile Device Use condition: Mothers will be asked to use their mobile device in a way they find relaxing and pleasurable during the feeding interaction.

Control condition: Mothers will be asked to feed their infant in a room free of all potential technological distractions.
Primary purpose: BASIC_SCIENCE

Brief summary: Maternal sensitivity and contingent responsiveness to infant behavioral cues is an important contributor to infants' developing capacities to self-regulate. During early infancy, feeding interactions comprise a significant portion of mother-infant dyadic interactions and high-quality feeding interactions provide both nutritive and socioemotional benefits; recent data suggest that, for many dyads, mothers' sensitive responsiveness during feeding interactions is routinely impacted by the omnipresence of portable technology. The objective of the proposed research is to better understand the development and possible impacts of maternal technology use on infant feeding interactions, emotion and intake regulation, and sociobehavioral and growth outcomes.

Detailed description: The development of effective self-regulation is one of the most important achievements of early childhood and is associated with better stress reactivity, lower risk for internalizing and externalizing problems, and lower risk for obesity. During infancy, key interconnected domains of self-regulation include emotion (i.e., distress regulation) and feeding (i.e., caloric intake regulation). An important contributor to regulation across these domains is synchrony in caregiver-infant interactions, of which a critical component is caregiver sensitive responsiveness to infant cues. Feeding interactions comprise a majority of early interactions and high quality, synchronous feeding interactions provide the infant with both nutritive and socioemotional benefits.

Given recent increases in portable technology use over the past decade, as well as further increases due to social distancing in response to the COVID-19 pandemic, there is growing concern that the omnipresence of technology impacts the nature and quality of family interactions. The PI's previous research illustrates 92% of mothers reported engaging with technological distractors (e.g., watching TV, using mobile devices) during infant feeding and distracted mothers exhibited lower sensitivity than mothers who were not distracted. Short-term experimental studies illustrate maternal technology use reduces the quality of dyadic interaction by decreasing maternal engagement, reducing maternal responsiveness to infants' attention bids, and evoking undesirable infant responses, including increased negative affect and poorer focus. These findings are concerning, but the field is critically limited by a lack of longitudinal data to inform whether these short-term impacts are indicative of long-term detriments to infant development.

The present study is a novel longitudinal study featuring within-subject experimental manipulations and intensive assessments to better understand how maternal technology use impacts infant socioemotional, feeding, and growth outcomes. 345 women will be recruited during the 3rd trimester of pregnancy, then will be assessed 1, 4, 6, 9, and 12 months postpartum.

The following aims will be addressed:

Aim 1: Examine impacts of maternal technology use on early feeding interactions and change in these impacts across early infancy. At 1 month and 4 months, dyadic interactions will be observed during 3 counterbalanced within-subject experimental feeding conditions: 1) Control: mothers will not engage with TV or mobile devices; 2) TV Use: mothers will watch a TV show; 3) Mobile Device Use: mothers will use a mobile device. Videos of these interactions will be coded to obtain a comprehensive understanding of whether and how maternal technology use influences dyadic interactions, as well as potential bidirectional associations between maternal and infant behavioral responses. Experimental data will be combined with longitudinal data on habitual maternal technology use (see Aim 3) to understand: a) effects of experimentally-manipulated technology use on maternal attention, sensitivity to infant cues, and engagement of the infant, and on infant clarity of cues, attentional responsiveness to the mother, and intake; b) stability vs. change in these effects between 1mo and 4mo; c) moderating effects of habitual maternal technology use (assessed via passive sensing at 1mo and 4mo) on stability vs. change in behavioral responses to experimentally manipulated technology use.

Aim 2: Test the hypothesis that greater habitual maternal technology use predicts poorer infant emotion and intake regulation when infants are 6 and 12 months, and greater weight gain from birth-12 months. Infant emotion and intake regulation, and related socioemotional and behavioral problems, will be assessed through established behavioral protocols and maternal report via validated questionnaires. Longitudinal associations between habitual maternal technology use and infant outcomes will be examined, as well as potential mediating or moderating effects of maternal sensitive responsiveness (objectively assessed via naturalistic feeding and play observations) or feeding mode (breast- vs. bottle-feeding), respectively.

Aim 3: Describe levels of and changes in habitual maternal technology use between the prenatal and postpartum periods and examine predictors of habitual technology use patterns. Passive sensing (via an app) of maternal technology use will be integrated with time diaries to describe total daily technology use and use during infant feeding interactions at each assessment. Hypothesized predictors of habitual technology use include maternal depressive symptoms, stress, emotion regulation, feeding styles, and reflective functioning. The investigators will also examine whether habitual maternal technology use is predicted by infant characteristics, including infant behavioral responses to experimentally manipulated technology use, sex as a biological variable, eating behaviors, and temperament.

The proposed research will employ innovative approaches to answer questions relevant to today's technology-focused society. Findings will provide a foundation for the development of targeted interventions that strengthen mothers' abilities: 1) to be sensitive and attentive to their children in the presence of distracting technology and 2) effectively integrate technology use into family contexts in ways that preserve benefits and minimize risks.

Eligibility criteria: Eligibility Criteria

At the time of recruitment, eligibility criteria for participants will include:

* 18 years of age or older
* In 3rd trimester of singleton pregnancy
* History of healthy, low-risk pregnancy
* Lives within 50 miles of the Cal Poly campus
* Owns a mobile device

After the child is born, eligibility criteria for participants will remain in the study will include:

* Infant was born term (gestational age ≥37 weeks) Exclusion criteria include
* Mother has an untreated medical or psychiatric condition (e.g. bipolar disorder) that could impede study participation or affect mother-infant interaction
* Mother is participating in another interventional study that influences parenting, mother-infant interactions, feeding practices, or technology use
* The mother is unwilling or unable to commit to longitudinal follow-ups of herself or her child
* Infant was born preterm (gestational age \<37 weeks)
* Infant diagnosed with fetal abnormality or medical condition that interferes with oral feeding (e.g., feeding disorder, milk protein allergy) or development
* Infant diagnosed with developmental delay (e.g., Down's syndrome)

Primary outcomes:
measure: Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Maternal Sensitivity to Infant Cues during Feeding
timeFrame: Infant ages 1 month and 4 months
measure: Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Maternal Socioemotional Growth Fostering during Feeding
timeFrame: Infant ages 1 month and 4 months
measure: Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Maternal Cognitive Growth Fostering during Feeding
timeFrame: Infant ages 1 month and 4 months
measure: Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Maternal Attentiveness to the Infant during Feeding
timeFrame: Infant ages 1 month and 4 months
measure: Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Infant Clarity of Cues during Feeding
timeFrame: Infant ages 1 month and 4 months
measure: Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Infant Attentional Responsiveness to the Mother during Feeding
timeFrame: Infant ages 1 month and 4 months
measure: Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Infant Intake Feeding
timeFrame: Infant ages 1 month and 4 months
measure: Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Meal Duration
timeFrame: Infant ages 1 month and 4 months
measure: Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Rate of Feeding
timeFrame: Infant ages 1 month and 4 months
measure: Change Infant Emotion Regulation between infant ages 4 months, 6 months, and 12 months
timeFrame: Infant ages 4 months, 6 months, and 12 months
measure: Change in Infant Intake Regulation between infant ages 4 months, 6 months, and 12 months
timeFrame: Infant ages 4 months, 6 months, and 12 months
measure: Infant Socioemotional and Behavioral Problems
timeFrame: Infant age 12 months
measure: Change in infant weight between birth and 12 months of age
timeFrame: Birth to 12 months
Secondary outcomes:
measure: Maternal habitual technology use
timeFrame: Prenatal to 12 months postpartum
Other outcomes:
Locations:
city: San Luis Obispo
country: United States
facility: California Polytechnic State University
state: California
Study officials:
References: