SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers

NCT ID: NCT06030830

Last Updated: 2023-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-06

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Smartphone Addiction Breastfeeding Infant Behavior Mother-Infant Interaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Intervention

Participants will be instructed not to use the smartphone during breastfeeding for a week

Group Type EXPERIMENTAL

SMaRT Mom

Intervention Type BEHAVIORAL

"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.

Control

Participants will not be instructed not to use the smartphone during breastfeeding for a week

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bar-Ilan University, Israel

OTHER

Sponsor Role lead

Responsible Party

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Prof. Ilanit gordon

prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ilanit Gordon, Prof.

Role: STUDY_CHAIR

Department of Psychology, Gonda Brain Research Center Bar-Ilan University

Locations

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Gonda Brain Center, Bar-Ilan University

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ilanit Gordon, Prof.

Role: CONTACT

+972 - 3-5317520

Lilach Graff Nomkin, PhD student

Role: CONTACT

: +972545445013

Facility Contacts

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Ilanit Gordon, Prof.

Role: primary

Other Identifiers

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IG30623

Identifier Type: -

Identifier Source: org_study_id

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