- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06030830
SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers (SMaRT)
September 2, 2023 updated by: Prof. Ilanit gordon, Bar-Ilan University, Israel
SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers - An Intervention Study
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ilanit Gordon, Prof.
- Phone Number: +972 - 3-5317520
- Email: ilanit.gordon@biu.ac.il
Study Contact Backup
- Name: Lilach Graff Nomkin, PhD student
- Phone Number: : +972545445013
- Email: lgnomkin@gmail.com
Study Locations
-
-
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Ramat Gan, Israel
- Recruiting
- Gonda Brain Center, Bar-Ilan University
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Contact:
- Ilanit Gordon, Prof.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Participants will be instructed not to use the smartphone during breastfeeding for a week
|
"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.
|
No Intervention: Control
Participants will not be instructed not to use the smartphone during breastfeeding for a week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant temperament
Time Frame: Pre (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
|
Pre (day 1) and post (day 8) lab visit (before and after intervention/control week)
|
Maternal self-efficacy
Time Frame: Pre (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 |
Pre (day 1) and post (day 8) lab visit (before and after intervention/control week)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breastfeeding as a rewarding experience
Time Frame: Pre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control week
|
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
|
Self-reported maternal attention towards infant
Time Frame: Pre (day 1) and post (day 8, day 14, day 30) lab visit after intervention/control week
|
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
|
Video recorded maternal attention towards infant
Time Frame: day 1 and day 8 during lab visits
|
Maternal attention towards the infant will be video recorded during both laboratory sessions
|
day 1 and day 8 during lab visits
|
Changes in breastfeeding mothers' neural activity - Frontal asymmetry
Time Frame: day 1 and day 8 during lab visits
|
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
|
Changes in breastfeeding mothers' neural activity - ERP
Time Frame: day 1 and day 8 during lab visits
|
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
|
Changes in breastfeeding mothers' physiological responses - HRV
Time Frame: day 1 and day 8 during lab visits
|
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
|
Changes in breastfeeding mothers' physiological responses - Electrodermal activity
Time Frame: day 1 and day 8 during lab visits
|
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
|
Changes in breastfeeding mothers' physiological responses - Cardiograph Impedance
Time Frame: day 1 and day 8 during lab visits
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ilanit Gordon, Prof., Department of Psychology, Gonda Brain Research Center Bar-Ilan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2023
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
October 1, 2025
Study Registration Dates
First Submitted
August 27, 2023
First Submitted That Met QC Criteria
September 2, 2023
First Posted (Actual)
September 11, 2023
Study Record Updates
Last Update Posted (Actual)
September 11, 2023
Last Update Submitted That Met QC Criteria
September 2, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IG30623
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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