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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

345

participants targeted

Target at P75+ for not_applicable

Timeline

14mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.5 years study duration

Study Progress74%

Jan 2023Jun 2027

Study Start

First participant enrolled

January 16, 2023

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed

23 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

4 years

First QC Date

February 28, 2023

Last Update Submit

February 21, 2025

Conditions

Mobile Phone Use Mother-Infant Interaction Infant Development Self-Regulation, Emotion Self-Regulation

Outcome Measures

Primary Outcomes (13)

Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Maternal Sensitivity to Infant Cues during Feeding
When infants are 1 month and 4 months of age, mother-infant dyads will be observed during 3 within-subject experimental feeding conditions: TV Use, Mobile Device Use, or Control. Videos of feeding interactions will be later coded using the Nursing Child Assessment Parent-Child Interaction Feeding Scale (NCAFS). Possible score range for the Maternal Sensitivity to Infant Cues subscale is 0-16 with higher scores representing greater maternal sensitivity to infant cues.
Infant ages 1 month and 4 months
Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Maternal Socioemotional Growth Fostering during Feeding
When infants are 1 month and 4 months of age, mother-infant dyads will be observed during 3 within-subject experimental feeding conditions: TV Use, Mobile Device Use, or Control. Videos of feeding interactions will be later coded using the Nursing Child Assessment Parent-Child Interaction Feeding Scale (NCAFS). Possible score range for the Maternal Socioemotional Growth Fostering subscale is 0-14 with higher scores representing greater maternal socioemotional growth fostering.
Infant ages 1 month and 4 months
Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Maternal Cognitive Growth Fostering during Feeding
When infants are 1 month and 4 months of age, mother-infant dyads will be observed during 3 within-subject experimental feeding conditions: TV Use, Mobile Device Use, or Control. Videos of feeding interactions will be later coded using the Nursing Child Assessment Parent-Child Interaction Feeding Scale (NCAFS). Possible score range for the Maternal Cognitive Growth Fostering subscale is 0-9 with higher scores representing greater maternal cognitive growth fostering.
Infant ages 1 month and 4 months
Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Maternal Attentiveness to the Infant during Feeding
When infants are 1 month and 4 months of age, mother-infant dyads will be observed during 3 within-subject experimental feeding conditions: TV Use, Mobile Device Use, or Control. Videos of feeding interactions will be later coded to determine the percentage of time the mother spent looking at the device versus her infant, with greater percent time spent looking at the infant representing greater maternal attentiveness to the infant.
Infant ages 1 month and 4 months
Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Infant Clarity of Cues during Feeding
When infants are 1 month and 4 months of age, mother-infant dyads will be observed during 3 within-subject experimental feeding conditions: TV Use, Mobile Device Use, or Control. Videos of feeding interactions will be later coded using the Nursing Child Assessment Parent-Child Interaction Feeding Scale (NCAFS). Possible score range for the Infant Clarity of Cues subscale is 0-15 with higher scores representing greater infant clarity of cues.
Infant ages 1 month and 4 months
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
When infants are 1 month and 4 months of age, mother-infant dyads will be observed during 3 within-subject experimental feeding conditions: TV Use, Mobile Device Use, or Control. Videos of feeding interactions will be later coded to determine the percentage of time the infant spent looking at the mother, with greater percent time spent looking at the mother representing greater infant attentiveness to the mother.
Infant ages 1 month and 4 months
Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Infant Intake Feeding
When infants are 1 month and 4 months of age, mother-infant dyads will be observed during 3 within-subject experimental feeding conditions: TV Use, Mobile Device Use, or Control. The infant will be weighed before and after feeding to determine amount consumed during the feeding.
Infant ages 1 month and 4 months
Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Meal Duration
When infants are 1 month and 4 months of age, mother-infant dyads will be observed during 3 within-subject experimental feeding conditions: TV Use, Mobile Device Use, or Control. Videos of feeding interactions will be later coded to determine the duration of the meal.
Infant ages 1 month and 4 months
Change between infant age 1 month and 4 months for effects of TV and Mobile Devices on Rate of Feeding
When infants are 1 month and 4 months of age, mother-infant dyads will be observed during 3 within-subject experimental feeding conditions: TV Use, Mobile Device Use, or Control. Infant intake (mL) will be divided by meal duration (min) to determine rate of feeding (mL/min).
Infant ages 1 month and 4 months
Change Infant Emotion Regulation between infant ages 4 months, 6 months, and 12 months
Infant emotion regulation capacity will be assessed via both observational and maternal-reported measures. Observational measures will come from infant behavior during the Still Face Paradigm described in the intervention section; videos of infant behavior during this paradigm will be coded using the infant-caregiver engagement phases (ICEP). Maternal-reported emotion regulation will come from the Infant Behavior Questionnaire-Revised Very Short Form. These observational and maternal-reported measures will be combined into a composite score representing infant emotion regulation capacity. Greater scores will represent greater emotion regulation capacity.
Infant ages 4 months, 6 months, and 12 months
Change in Infant Intake Regulation between infant ages 4 months, 6 months, and 12 months
Infant intake regulation capacity will be assessed via both observational and maternal-reported measures. Infant intake regulation will be assessed via percent difference scores gleaned from the Caloric Compensation and COMPX protocols described in the intervention section. Maternal reported infant self-regulation of intake (satiety responsiveness) will also be assessing using the Baby Eating Behavior Questionnaire (BEBQ) at and the Child Eating Behavior Questionnaire for Toddlers (CEBQ-T). These observational and maternal-reported measures will be combined into a composite score representing infant intake regulation capacity. Greater scores will represent greater intake regulation capacity.
Infant ages 4 months, 6 months, and 12 months
Infant Socioemotional and Behavioral Problems
Mothers will complete the Brief Infant-Toddler Social Emotional Assessment (BITSEA), a 42-item questionnaire that indexes the presence of social-emotional and behavioral problems and competencies that has been extensively validated for use with children from 12-36 months of age. Broad domains assessed include Internalizing (depression/withdrawal, general anxiety, inhibition to novelty, separation distress subscales), Externalizing (activity/impulsivity, aggression/defiance, peer aggression subscales), Dysregulation (negative emotionality, sleep, eating, sensory sensitivity subscales), and Competence (compliance, attention, mastery motivation, imitation/play, empathy, prosocial peer relations subscales). A mean score will be calculated with higher scores indicating poorer socioemotional and behavioral adjustment.
Infant age 12 months
Change in infant weight between birth and 12 months of age
A trained research assistant will collect infant weight and length measurements in triplicate using an infant scale/infantometer (models 374 and 233; Seca, Hamburg, Germany). Infant anthropometric data will be normalized to z-scores using the World Health Organization (WHO) Anthro software (http://www.who.int/childgrowth/en/) to calculate age- and sex-specific z-scores based on the WHO growth standards.
Birth to 12 months

Secondary Outcomes (1)

Maternal habitual technology use
Prenatal to 12 months postpartum

Study Arms (6)

Order of Technology Use during Feeding Conditions: TV Use, Mobile Device Use, Control

EXPERIMENTAL

This arm will be exposed to the feeding conditions in the following order: TV Use, Mobile Device Use, Control