SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers

Breastfeeding Clinical Trial

— SMaRT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06030830
• Other study ID #: IG30623
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2023
• Est. completion date: October 2025

Study information

• Verified date: September 2023
• Source: Bar-Ilan University, Israel
• Contact: Ilanit Gordon, Prof.
• Phone: +972 - 3-5317520
• Email: ilanit.gordon[@]biu.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• SMaRT 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.

Locations

Country	Name	City	State
Israel	Gonda Brain Center, Bar-Ilan University	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Bar-Ilan University, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant temperament	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	Pre (day 1) and post (day 8) lab visit (before and after intervention/control week)
Primary	Maternal self-efficacy	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	Pre (day 1) and post (day 8) lab visit (before and after intervention/control week)
Secondary	Breastfeeding as a rewarding experience	The 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?")	Pre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control week
Secondary	Self-reported maternal attention towards infant	Maternal 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?")	Pre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control week
Secondary	Video recorded maternal attention towards infant	Maternal attention towards the infant will be video recorded during both laboratory sessions	day 1 and day 8 during lab visits
Secondary	Changes in breastfeeding mothers' neural activity - Frontal asymmetry	Frontal 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.	day 1 and day 8 during lab visits
Secondary	Changes in breastfeeding mothers' neural activity - ERP	Event 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	day 1 and day 8 during lab visits
Secondary	Changes in breastfeeding mothers' physiological responses - HRV	Heart 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).	day 1 and day 8 during lab visits
Secondary	Changes in breastfeeding mothers' physiological responses - Electrodermal activity	Skin 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).	day 1 and day 8 during lab visits
Secondary	Changes in breastfeeding mothers' physiological responses - Cardiograph Impedance	Cardiograph 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).	day 1 and day 8 during lab visits