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Completed

NCT Number: NCT06286176

Breastfeeding Promotion in Lebanon Through a Salutogenic Intervention

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.

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Key information

Conditions

Breast Feeding Behavior Exclusive Breastfeeding Feeding Behavior Salutogenesis

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lebanese International University

Beirut, 146404, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Videos with breastfeeding education material and encouraging messages

Behavioral

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

Whatsapp group

Behavioral

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

Primary outcomes

  1. breastfeeding initiation

    Time frame: 1 hour after birth

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

  2. Duration of Exclusive breastfeeding

    Time frame: at 6 months postpartum

    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.

Secondary outcomes

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

    Time frame: The first measurement was taken 10 days before delivery and the second measurement was taken at 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

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

    Time frame: 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.

    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

Sponsors and collaborators

Lead sponsor

Nabiha Ramadan

Other

Collaborators

  • Universitat de Girona

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 29, 2024
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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