NCT06286176

Brief Summary

The study is a randomized control trial to assess the effect of a salutogenic intervention on breastfeeding initiation and duration of exclusive breastfeeding in Lebanon. In this Salutogenic intervention, infant feeding helpers will provide subjects of the intervention group breastfeeding related information , and will support these subjects by counseling and guiding them to find general resistance resources. This aims to increase sense of coherence and its parameters: comprehensibility, manageability and meaningfulness, which are the base of salutogenesis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

February 16, 2024

Last Update Submit

February 28, 2024

Conditions

Breast FeedingExclusive BreastfeedingSalutogenesis

Keywords

BreastfeedingSalutogenesisSense of coherence

Outcome Measures

Primary Outcomes (2)

  • breastfeeding initiation

    Number of women who breastfed their infants within 1 hour after birth

    1 hour after birth

  • Duration of Exclusive breastfeeding

    number of women who are exclusively breastfeeding at 6 months postpartum. Exclusive breastfeeding indicates feeding infants only breastmilk without any other complementary food nor beverage.

    at 6 months postpartum

Secondary Outcomes (2)

  • Mean change in Self- esteem in participants from baseline to 6 months postpartum

    The first measurement was taken 10 days before delivery and the second measurement was taken at 6 months postpartum

  • The Change in Sense of Coherence (SOC) scores from baseline to 6 months postpartum

    1st measurement: 10 days before delivery. 2nd measurement: 6 months postpartum. Score measurements were taken twice per subject for comparison at the end of the intervention.

Study Arms (2)

Behavioral: videos

EXPERIMENTAL

4 videos are created and distributed to subjects in the intervention group. Video 1: 10 days before delivery Video 2: the day of the delivery Video 3: 1 week postpartum Video 4: 1 month postpartum Videos content: encouraging message, information related to breastfeeding management This is arm in applied in all subjects on the intervention group

Behavioral: Videos with breastfeeding education material and encouraging messages

Behavioral: Whatsapp group

EXPERIMENTAL

4 Whatsapp groups were created. Each Whatsapp group was moderated by 1 infant feeding helper. Each whatsapp group consisted of 10-15 subjects. Mothers asked breastfeeding related questions to infant feeding helpers and also exchange experience with the other mothers on the group. This is arm in applied in all subjects on the intervention group. Mothers of the intervention group joined their corresponding whatsapp group 10 days before expected delivery date and the duration of the intervention involving the whatsapp group was until 6 months postpartum.

Behavioral: Whatsapp group

Interventions

Videos with breastfeeding education material and encouraging messagesBEHAVIORAL

Distributed videos aim to increase breastfeeding related knowledge and to receive support

Behavioral: videos
Whatsapp groupBEHAVIORAL

The Whatsapp group is used in the intervention as a platform for interpersonal exchange of information and experience, in addition to peer support.

Behavioral: Whatsapp group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women and breastfeeding mothers
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women
  • Singleton
  • Healthy
  • New born not admitted to Neonatal Intensive Care Unit
  • Residing in Lebanon

You may not qualify if:

  • Pregnant with more than 1 fetus
  • Mothers with a health condition contraindicating breastfeeding
  • Newborn admitted to NICU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lebanese International University

Beirut, 146404, Lebanon

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.Sc, Lecturer in Nutrition and Dietetics

Study Record Dates

First Submitted

February 16, 2024

First Posted

February 29, 2024

Study Start

November 17, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

Informed consent form, scores of self esteem and scores of sense of coherence

Shared Documents
SAP, ICF, CSR

Locations

LE(1)