Effect of Health Information Package Program on Knowledge and Compliance Among Pregnant Women With Anemia

Effect of Health Information Package Program (HIP Program) on Knowledge, Compliance , and Hemoglobin Level Among Saudi Pregnant Women With Anemia: A Randomized Controlled Trial

Problem description: low compliance with iron supplementation of Saudi pregnant women with anemia is a serious public health concern. The objectives of the study are to determine the effectiveness of the Health Information Package Program (HIP program) in Saudi anemic pregnant women on their compliance with iron supplementation, and level of hemoglobin. Methodology: Randomized Controlled Trial will be conducted on 196 Saudi anemic pregnant women attending the Maternity and Children Hospital in Saudi Arabia their gestational age between 14 and less than 20 weeks. All participants will receive iron supplementation and they will learn how to take tablets. They will randomly assign to two intervention and control groups (98 each) using a computer-generated table of random numbers.

The intervention group will receive a PowerPoint presentation of the Health Information Package Program (HIP program) that will be introduced by the principal investigator, combined with PowerPoint slides to educate women about anemia in pregnancy and send it to them via Whatsapp application while the control group will receive usual care. The participants will be informed about the nature and aim of the study with assuring confidentiality and anonymity. Expected outcome: Health Information Package Program (HIP program) will be effective in terms of increasing women's knowledge regarding anemia during pregnancy, increase compliance with iron supplementation, and hemoglobin level.

Study Overview

• Status: Completed
• Conditions: Anemia; Pregnant Women; Knowledge
• Intervention / Treatment: Other: Health Information Package Program (HIP program )

Detailed Description

The present study aims to assess the efficacy of the Health information package program (HIP program) on compliance with iron supplementation pills, and the level of hemoglobin among Saudi pregnant women with anemia.

The study will be conducted in antenatal outpatient clinics at primary health care centers.

Data Collection tools

I- Demographic and health-related information included data related to women's age, marriage age, level of education, gestational age, parity, body mass index, inter-pregnancy interval, history of excessive or abnormal bleeding during menstruation, and level of hemoglobin.

II- compliance with iron supplementation included questions related to the extent of compliance with iron supplementation among anemic pregnant women and the reason for compliance or non-compliance.

III- The food selection ability checklist contained food items that are rich and poor sources of iron, vitamin C, and protein.

IV- Structured Knowledge Interview Schedule (SKIS): This tool was developed to assess women information before and after the intervention, it contained questions regarding the concept of pregnancy, anemia in pregnancy, causes of iron deficiency anemia, signs and symptoms, the effect of anemia on pregnancy, prevention, and management of iron deficiency anemia. Each correct answer is assigned one point. The maximum number of total possible points was 86.

Random assignment will use to classify the participants equally (98 women each) either in the intervention or control groups using a computer-generated table of random numbers.

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jouf
    • Jouf- Saudi Arabia, Jouf, Saudi Arabia, 3677
      • Primary Health Care centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

inclusion criteria

1. Aged between 18-45 years
2. Hemoglobin level less than11 gm/dl and hematocrit less than 30%
3. 14-20 pregnancy weeks
4. Singleton fetus
5. Have a smartphone with internet access (What's App) application
6. Able to read and write
7. Willing to give written informed consent to participate in the study.

Exclusion criteria:

1. Cannot read and write,
2. Have thalassemia or sickle cell anemia.
3. Have a high-risk pregnancy.
4. Had a history of psychiatric illness.
5. Have already started iron supplementation for more than one week.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; Routine care only They will receive routine antenatal care that included iron supplementation with follow up of hemoglobin level	Other: Health Information Package Program (HIP program ); Fifteen minutes PowerPoint presentation will be introduced to women to increase women's educational experience and raise their level of engagement and commitment. The principal investigator will narrate the video record with PowerPoint slides and it was recorded as a video and will include information regarding the introduction to pregnancy, causes and predisposing factors of iron deficiency anemia during pregnancy, signs and symptoms, prevention, management of iron deficiency anemia during pregnancy that includes iron therapy, iron supplementation, dietary management. Content validity for the information in the video will be done by sending it to three experts in maternity nursing. Iron supplementation will be given to all participants who will start by sixteen weeks of pregnancy and they will receive information regarding the proper usage of iron supplements.
Experimental: Intervention group; They will receive the Heath Information Package Program (HIP program)	Other: Health Information Package Program (HIP program ); Fifteen minutes PowerPoint presentation will be introduced to women to increase women's educational experience and raise their level of engagement and commitment. The principal investigator will narrate the video record with PowerPoint slides and it was recorded as a video and will include information regarding the introduction to pregnancy, causes and predisposing factors of iron deficiency anemia during pregnancy, signs and symptoms, prevention, management of iron deficiency anemia during pregnancy that includes iron therapy, iron supplementation, dietary management. Content validity for the information in the video will be done by sending it to three experts in maternity nursing. Iron supplementation will be given to all participants who will start by sixteen weeks of pregnancy and they will receive information regarding the proper usage of iron supplements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemoglobin	> 11 gm/ dl	after three months ( 90 days ± 7 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
knowledge	The overall number of knowledge related questions is 86 High knowledge: 57-71 Moderate knowledge: 36- 56 tablets Low knowledge: <36 tablets	after three months ( 90 days ± 7 days) - study period
compliance with iron supplementation	The overall number of iron tablets that should have been taken during the three month study period will be 90 High compliance: 68-90 tablets Moderate compliance: 45- 67 tablets Low compliance: <45 tablets	after three months ( 90 days ± 7 days)

Collaborators and Investigators

• Sponsor: Jouf University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: November 28, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: anemia; pregnant women; Health Information Package
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: DSR2020-04-3655

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No personal identification data will be collected, so the researchers assure participants' anonymity.; The researchers will collect only the data required to this study.; Demographic data of participants will be coded to maintain confidentiality.; All submitted data are saved and handled electronically by the researchers only through password-protected files.

Drug and device information, study documents

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