Breast FeedingNCT06286176
Breastfeeding Promotion in Lebanon Through a Salutogenic Intervention
A study testing Videos with breastfeeding education material and encouraging messages and Whatsapp group in people with Breast Feeding and Exclusive Breastfeeding, run by Nabiha Ramadan at 1 site in Lebanon.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Exclusive Breastfeeding, Salutogenesis
- What is being tested?
- Videos with breastfeeding education material and encouraging messages and Whatsapp group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteLebanon
- Study dates
- 17 Nov 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women
- Singleton
- Healthy
- New born not admitted to Neonatal Intensive Care Unit
- Residing in Lebanon
Who cannot join
- Pregnant with more than 1 fetus
- Mothers with a health condition contraindicating breastfeeding
- Newborn admitted to NICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Feeding, Exclusive Breastfeeding, Salutogenesis
- Being tested
- Videos with breastfeeding education material and encouraging messages, Whatsapp group
- Keywords
- Breastfeeding, Salutogenesis, Sense of coherence
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videos with breastfeeding education material and encouraging messagesBehavioural
Distributed videos aim to increase breastfeeding related knowledge and to receive support
Whatsapp groupBehavioural
The Whatsapp group is used in the intervention as a platform for interpersonal exchange of information and experience, in addition to peer support.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Whatsapp group |
What is being measured
The primary outcome is the main question the study is designed to answer.
breastfeeding initiation
Number of women who breastfed their infants within 1 hour after birth
Measured: 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.
Measured: at 6 months postpartum
Secondary outcomes (2)
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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start17 Nov 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nabiha Ramadan
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat de Girona
- Responsible party
- Sponsor-investigator, Nabiha Ramadan, Lebanese International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286176
- Sponsor's protocol ID
- LIUIRB-200311-NR1
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Informed consent form, scores of self esteem and scores of sense of coherence
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Breastfeeding Promotion in Lebanon Through a Salutogenic Intervention: A Clinical Trial
- ClinicalTrials.gov ID
- NCT06286176
- Acronym / sponsor ID
- LIUIRB-200311-NR1
- Conditions
- Breast Feeding, Exclusive Breastfeeding, Salutogenesis
- Keywords
- Breastfeeding, Salutogenesis, Sense of coherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Nabiha RamadanUniversity, hospital or other
- Collaborators
- Universitat de Girona
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral: videos | Experimental | Behavioral: Videos with breastfeeding education material and encouraging messages4 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: Whatsapp group | Experimental | Behavioral: Whatsapp group4 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women
- Singleton
- Healthy
- New born not admitted to Neonatal Intensive Care Unit
- Residing in Lebanon
Key exclusion criteria (3 listed)
- Pregnant with more than 1 fetus
- Mothers with a health condition contraindicating breastfeeding
- Newborn admitted to NICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Videos with breastfeeding education material and encouraging messagesDistributed videos aim to increase breastfeeding related knowledge and to receive support | Behavioural | Behavioral: videos |
| Whatsapp groupThe Whatsapp group is used in the intervention as a platform for interpersonal exchange of information and experience, in addition to peer support. | Behavioural | Behavioral: Whatsapp group |
Primary outcome
breastfeeding initiation
Time frame: 1 hour after birth
Number of women who breastfed their infants within 1 hour after birth
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.
2 secondary outcomes
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: Yes. Informed consent form, scores of self esteem and scores of sense of coherence
Related trials for Breast Feeding
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Recruiting
Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors
Breast Cancer
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videos with breastfeeding education material and encouraging messages and Whatsapp group in people with Breast Feeding and Exclusive Breastfeeding, run by Nabiha Ramadan at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
breastfeeding initiation (time frame: 1 hour after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.