Breastfeeding Promotion in Lebanon Through a Salutogenic Intervention

Enhancing Breastfeeding Promotion in Lebanon Through a Salutogenic Intervention: A Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Breast Feeding; Exclusive Breastfeeding; Salutogenesis
• Intervention / Treatment: Behavioral: Videos with breastfeeding education material and encouraging messages; Behavioral: Whatsapp group

Detailed Description

Pregnant women were recruited in their 3rd trimester of pregnancy and were randomly assigned to either an intervention or control group.

Both groups received standard breastfeeding education at the maternity ward. Additionally, the intervention is based on informative and supportive videos and a whatsapp group for interpersonal support. Videos and whatsapp groups were created and moderated by Infant Feeding Helpers. These are women from the same socio-economical background as the subjects, and have previous history of breastfeeding a minimum of 6 months exclusive breastfeeding.

The aim of the intervention was to increase initiation and duration of breastfeeding by increasing comprehensibility, manageability and meaningfulness of the breastfeeding period and therefore by enhancing their sense of coherence.

Chi-squared tests were used for descriptive statistics, Wilcoxon test was used for pre- post results of SOC and (SE) within each group. The change in pre-post SOC, SOC parameters and SE scores between control and intervention groups was analyzed with Quade non parametric.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 146404
    • Lebanese International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral: videos; 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; Distributed videos aim to increase breastfeeding related knowledge and to receive support
Experimental: Behavioral: Whatsapp group; 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; The Whatsapp group is used in the intervention as a platform for interpersonal exchange of information and experience, in addition to peer support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in Self- esteem in participants from baseline to 6 months postpartum	Measuring the scores of the Rosenberg Self Esteem Scale- 10 items. Scores are from 0 to 30. Higher scores indicate higher self esteem	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	The score of the "Sense of Coherence- 13 items" questionnaire. The minimum score is 13, and the maximum score is 91. Higher score indicates higher sense of coherence	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.

Collaborators and Investigators

• Sponsor: Nabiha Ramadan
• Collaborators: Universitat de Girona

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Breastfeeding; Sense of coherence; Salutogenesis
• Other Study ID Numbers: LIUIRB-200311-NR1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Informed consent form, scores of self esteem and scores of sense of coherence
• IPD Sharing Supporting Information Type: SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No