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SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers

SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers - An Intervention Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06030830
Acronym
SMaRT
Enrollment
100
Registered
2023-09-11
Start date
2023-06-06
Completion date
2025-10-31
Last updated
2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, Infant Behavior, Mother-Infant Interaction, Smartphone Addiction

Keywords

Smartphone addiction, Problematic smartphone use, Breastfeeding, Infant temperament, Mother-infant interaction

Brief summary

In the last decade, infants are born into a social environment in which the smartphone has become an essential part of our lives. Smartphone use draws the mother's attention during mother-infant interactions and thus may affect the infant development as well as maternal self-efficacy. However, the effects of smartphone use reduction among breastfeeding mothers during their interactions with their infants have not been studied yet. In the present study, we propose to evaluate a SMaRT Mom intervention that we have developed, to manage and reduce smartphone use during breastfeeding. The purpose of the study is to evaluate the effects of the SMaRT Mom intervention on breastfeeding mothers' biobehavioral mechanisms, self-efficacy and the socioemotional characteristics of their infants. This will extend our knowledge of the peculiarities of early mother-infant interactions in the digital era, when smartphones play a critical role.

Interventions

BEHAVIORALSMaRT Mom

SMaRT Mom intervention that we have developed is based on several approaches to digital addiction detection, prevention, and intervention aimed to help breastfeeding mothers to manage and reduce smartphone use during breastfeeding. The SMaRT Mom intervention results will be measured in changes in two main outcomes: 1) reduced maternal reports of their infants' negative emotionality, and 2) increased maternal self-efficacy as distal outcomes as well as two proximal outcomes: 1) breastfeeding as a rewarding experience, and 2) maternal attention towards their infant during breastfeeding. We will then assess changes in breastfeeding mothers' neural activity, physiology and behavior before and after the implementation of the SMaRT Mom intervention, as potential mechanisms underlying changes in the main outcomes of the intervention.

Sponsors

Bar-Ilan University, Israel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

The intervention given to the intervention group will be hidden from participants in the control group, and they will not be asked to refrain from using their smartphones for a week. Participants in the control group will be given information about the intervention week after the second lab visit and allowed to undergo the same intervention the following week.

Intervention model description

The SMaRT Mom intervention plan will be administered for one week during which mothers will be instructed not using their smartphone while breastfeeding. Before and after the intervention week, two lab sessions will be take place in which mothers in both intervention and control groups will be asked to take a screen shot of their smart digital use of the past week, and will be connected to the electrophysiological monitoring systems to assess their biobehavioral responses during: baseline, the smartphone cue-reactivity task, breastfeeding and face-to-face interaction while using or not using the smartphone. Following the first lab visit, mothers will be instructed to follow the intervention program. The participants will be asked to complete three daily reports of any distractions while breastfeeding. During the intervention week, two remote sessions (20 minutes each) will be performed by a research assistance to support the implementation of the intervention plan.

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 3-6 months old infant * Smartphone Addiction Scale' cut-off (31 and above)

Exclusion criteria

* No neurological disorders * No heart disease * No anxiety and depression * No use of psychiatric drugs

Design outcomes

Primary

MeasureTime frameDescription
Infant temperamentPre (day 1) and post (day 8) lab visit (before and after intervention/control week)Infants' temperament will be reported by breastfeeding mothers before and after the intervention week using the Infant Behavior Questionnaire - Revised - Very Short Form (IBQ-rvsf). Scale scores represent the mean score of all scale items applicable to the child, as judged by the caregiver. 1. Sum all numerical item responses for a given scale. Note that: a) If caregiver omitted an item, that item receives no numerical score; b) If caregiver checked the does not apply response option for an item, that item receives no numerical score; 2. Divide the total by the number of items receiving a numerical response. Not including items marked does not apply (N/A) or items receiving no response in determining the number of items. The surgency, negative affect and effortful control subscales' items will be averaged
Maternal self-efficacyPre (day 1) and post (day 8) lab visit (before and after intervention/control week)Maternal self-efficacy questionnaire (MSQ) will be self-reported by breastfeeding mothers before and after the intervention week. The scale applies a special method to measure maternal self-efficacy and mostly focuses on a mother's infant care responsibilities. The scale consists of 10 items.Higher score indicates higher maternal self-efficacy

Secondary

MeasureTime frameDescription
Video recorded maternal attention towards infantday 1 and day 8 during lab visitsMaternal attention towards the infant will be video recorded during both laboratory sessions
Changes in breastfeeding mothers' neural activity - Frontal asymmetryday 1 and day 8 during lab visitsFrontal asymmetry during maternal baseline, breastfeeding and mother-infant face-to-face interaction EEG data will be acquired from breastfeeding mothers' heads using Enobio8 device with eight electrodes from the frontal, and central-parietal areas - Fp1, Fp2, F3, F4, F7, F8, P3 and P4 and voltage fluctuations in the alpha frequency band will be measured between pairs of electrodes that will be produced by the excitation of neuronal synapses.
Changes in breastfeeding mothers' neural activity - ERPday 1 and day 8 during lab visitsEvent related response during the smartphone cue-reactivity task, attentional bias is indicated by an enhancement in the late positive potential (LPP), which is strongly evoked by emotionally salient stimuli. The LPP is maximum over central-parietal regions occurring between 300 and 700 ms following an emotional stimulus
Breastfeeding as a rewarding experiencePre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control weekThe rewarding experience of breastfeeding will be self-reported by mothers before and after the intervention week (How rewarding is the experience of breastfeeding for you?)
Changes in breastfeeding mothers' physiological responses - Electrodermal activityday 1 and day 8 during lab visitsSkin Conductance Level (SCL) will be measured via The MindWare Mobile Recorder (MindWare Technologies, Inc., Gahanna, OH), a well-validated and specialized hardware and software system that is aimed at monitoring autonomic balance, cardiac performance, respiratory measurements and activity. Participants are each will be fitted with a MindWare Mobile device and specialized electrodes to measure the electrocardiogram (allows to derive HRV), Z0, dz/dt (allows to assess respiration and cardiology impedance) and SCL (allows to derive electrodermal activity from the skin) (for similar method see Nomkin & Gordon, 2021).
Changes in breastfeeding mothers' physiological responses - Cardiograph Impedanceday 1 and day 8 during lab visitsCardiograph Impedance will be measured via The MindWare Mobile Recorder (MindWare Technologies, Inc., Gahanna, OH), a well-validated and specialized hardware and software system that is aimed at monitoring autonomic balance, cardiac performance, respiratory measurements and activity. Participants are each will be fitted with a MindWare Mobile device and specialized electrodes to measure the electrocardiogram (allows to derive HRV), Z0, dz/dt (allows to assess respiration and cardiology impedance) and SCL (allows to derive electrodermal activity from the skin) (for similar method see Nomkin & Gordon, 2021).
Changes in breastfeeding mothers' physiological responses - HRVday 1 and day 8 during lab visitsHeart Rate Variability (HRV) will be measured via The MindWare Mobile Recorder (MindWare Technologies, Inc., Gahanna, OH), a well-validated and specialized hardware and software system that is aimed at monitoring autonomic balance, cardiac performance, respiratory measurements and activity. Participants are each will be fitted with a MindWare Mobile device and specialized electrodes to measure the electrocardiogram (allows to derive HRV), Z0, dz/dt (allows to assess respiration and cardiology impedance) and SCL (allows to derive electrodermal activity from the skin) (for similar method see Nomkin & Gordon, 2021).
Self-reported maternal attention towards infantPre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control weekMaternal attention towards the infant will be self-reported by mothers before and after the intervention week (How attentive do you feel towards your infant during breastfeeding?)

Countries

Israel

Contacts

Primary ContactIlanit Gordon, Prof.
ilanit.gordon@biu.ac.il+972 - 3-5317520
Backup ContactLilach Graff Nomkin, PhD student
lgnomkin@gmail.com: +972545445013

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026