## Protocol Section
### Identification Module
**NCT ID:** NCT06423534

**Brief Title:** Empowering New Mothers: Exploring the Effect of Breastfeeding Health Educational Program on Practices and Feeding Self-Efficacy of Primigravida in Saudi Arabia

**Official Title:** Empowering New Mothers: Exploring the Effect of Breastfeeding Health Educational Program on Practices and Feeding Self-Efficacy of Primigravida in Saudi Arabia

#### Organization Study ID Info
**ID:** H-2024-126
#### Organization
**Class:** OTHER
**Full Name:** Alexandria University
### Status Module
#### Completion Date
**Date:** 2024-08-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Alexandria University

#### Responsible Party

**Investigator Affiliation:** Alexandria University

**Investigator Full Name:** Mahmoud Khedr

**Investigator Title:** Lecturer

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Being pregnant causes a mother and her child to form a maternal tie, and the birth of the child fills the mother with an immense amount of love and happiness. Breastfeeding is how a mother and infant make their initial touch. Breastfeeding is a mother's priceless gift to her infant and nature's own method of nurturing a baby.

**Detailed Description:** This study will be done to evaluate the primigravida mother's breastfeeding's knowledge, attitude and corrective technique through the implementation of an educational program and to ascertain the efficacy of such a program.

### Conditions Module

**Conditions:**

- Primigravida Women

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 70

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Each primigravida in the study group during the last three trimesters will receive three sessions of knowledge, breast care, and breastfeeding technique after filling out a questionnaire (pretest). During 1 month from delivery, we will conduct a post-test with them (after 2 weeks and after 4 weeks) to explore the effect of breastfeeding health educational programs on practices and breastfeeding self-efficacy

**Intervention Names:**

- Behavioral: Breastfeeding Health Educational Program

**Label:** Study GROUP

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The control group was selected first and received a brochure leaflet delivered by the researcher. They didn't receive the health educational program

**Intervention Names:**

- Behavioral: Breastfeeding Health Educational Program

**Label:** Control group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control group

- Study GROUP

**Description:** Breastfeeding is a mother's priceless gift to her infant and nature's own method of nurturing a baby. Therefore, this study will be conducted to evaluate the primigravida mother's breastfeeding's knowledge, attitude and corrective technique through the implementation of an educational program and to ascertain the efficacy of such a program.

**Name:** Breastfeeding Health Educational Program

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** It was developed by Tella et al. (2016) and comprised 12 questions that were assessed in various areas under various breastfeeding techniques practice.

**Measure:** A preformatted structured questionnaire

**Time Frame:** 3 months

**Description:** It was adopted (Dennis, 2003) that assess maternal self-efficacy for breastfeeding throughout all stages of the study. The BSES-SF is a Likert scale with 14 items organized into two domains, namely: technical and intrapersonal thoughts.

**Measure:** Self-Efficacy Scale - Short-Form (BSES-SF)

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Primigravida mothers who regularly visit maternity hospitals at Hail and Bisha City.
* Primigravida mothers during last three trimester and 1 month after delivery
* No problems during pregnant and have a healthy baby
* Primigravida mothers who are not contraindicated to breastfeeding

Exclusion Criteria:

* Multigravida mothers and pregnant women during first and second trimester

**Maximum Age:** 45 Years

**Minimum Age:** 17 Years

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hail

**Contacts:**

***Contact 1:***

- **Email:** a.alabd@uoh.edu.sa

- **Name:** Asmaa Ali

- **Phone:** 543132470

- **Role:** CONTACT

**Country:** Saudi Arabia

**Facility:** Faculty of Nursing, Hail university

**Status:** RECRUITING

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
