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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Lilach Graff Nomkin, PhD student
  • Phone Number: : +972545445013
  • Email: lgnomkin@gmail.com

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Recruiting
        • Gonda Brain Center, Bar-Ilan University
        • Contact:
          • Ilanit Gordon, Prof.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Participants will be instructed not to use the smartphone during breastfeeding for a week
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.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bar-Ilan University, Israel

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings