KnowledgeNCT04661865
Effect of Health Information Package Program on Knowledge and Compliance Among Pregnant Women With Anemia
A study testing Health Information Package Program (HIP program ) in people with Knowledge and Anemia, run by Jouf University at 1 site in Saudi Arabia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Knowledge, Anemia, Pregnant Women
- What is being tested?
- Health Information Package Program (HIP program )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2021to 31 May 2021
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18-45 years
- Hemoglobin level less than11 gm/dl and hematocrit less than 30%
- 14-20 pregnancy weeks
- Singleton fetus
- Have a smartphone with internet access (What's App) application
- Able to read and write
- Willing to give written informed consent to participate in the study.
Who cannot join
- Cannot read and write,
- Have thalassemia or sickle cell anemia.
- Have a high-risk pregnancy.
- Had a history of psychiatric illness.
- Have already started iron supplementation for more than one week.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Primary Health Care centers
Jouf- Saudi Arabia, Jouf, 3677
About this study
Official title: 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.
Read the 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.
- Conditions
- Knowledge, Anemia, Pregnant Women
- Being tested
- Health Information Package Program (HIP program )
- Keywords
- Health Information Package, anemia, pregnant women
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Information Package Program (HIP program )Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Routine care only They will receive routine antenatal care that included iron supplementation with follow up of hemoglobin level Receives: Other: Health Information Package Program (HIP program ) |
| Intervention group | Experimental | They will receive the Heath Information Package Program (HIP program) Receives: Other: Health Information Package Program (HIP program ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin
> 11 gm/ dl
Measured: after three months ( 90 days ± 7 days)
Secondary outcomes (2)
knowledge
The overall number of knowledge related questions is 86 High knowledge: 57-71 Moderate knowledge: 36- 56 tablets Low knowledge: <36 tablets
Measured: 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
Measured: after three months ( 90 days ± 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 Jan 2021
- Primary completion30 Apr 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KnowledgeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A: intervention group who will receive iron supplementation and Heath Information Package Program (HIP program) Group B: Control group: will receive iron supplementation and routine care
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jouf University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Elsharkawy, Jouf University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661865
- Sponsor's protocol ID
- DSR2020-04-3655
- Status last verified
- Jul 2021
- First submitted
- 28 Nov 2020
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 1. No personal identification data will be collected, so the researchers assure participants' anonymity. 2. The researchers will collect only the data required to this study. 3. Demographic data of participants will be coded to maintain confidentiality. 4. All submitted data are saved and handled electronically by the researchers only through password-protected files.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Health Information Package Program (HIP Program) on Knowledge, Compliance , and Hemoglobin Level Among Saudi Pregnant Women With Anemia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04661865
- Acronym / sponsor ID
- DSR2020-04-3655
- Conditions
- Knowledge, Anemia, Pregnant Women
- Keywords
- Health Information Package, anemia, pregnant women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Jouf UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 10 Dec 2020 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Group A: intervention group who will receive iron supplementation and Heath Information Package Program (HIP program) Group B: Control group: will receive iron supplementation and routine care
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Health Information Package Program (HIP program )Routine care only They will receive routine antenatal care that included iron supplementation with follow up of hemoglobin level |
| Intervention group | Experimental | Other: Health Information Package Program (HIP program )They will receive the Heath Information Package Program (HIP program) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged between 18-45 years
- Hemoglobin level less than11 gm/dl and hematocrit less than 30%
- 14-20 pregnancy weeks
- Singleton fetus
- Have a smartphone with internet access (What's App) application
Key exclusion criteria (5 listed)
- Cannot read and write,
- Have thalassemia or sickle cell anemia.
- Have a high-risk pregnancy.
- Had a history of psychiatric illness.
- Have already started iron supplementation for more than one week.
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 |
|---|---|---|
| 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. | Other | Control group, Intervention group |
Primary outcome
Haemoglobin
Time frame: after three months ( 90 days ± 7 days)
> 11 gm/ dl
2 secondary outcomes
knowledge
Time frame: after three months ( 90 days ± 7 days) - study period
compliance with iron supplementation
Time frame: after three months ( 90 days ± 7 days)
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 4 Aug 2021.
- Individual participant dataSharing planned: No. 1. No personal identification data will be collected, so the researchers assure participants' anonymity. 2. The researchers will collect only the data required to this study. 3. Demographic data of participants will be coded to maintain confidentiality. 4. All submitted data are saved and handled electronically by the researchers only through password-protected files.
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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 Health Information Package Program (HIP program ) in people with Knowledge and Anemia, run by Jouf University at 1 site in Saudi Arabia.
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 7 inclusion and 5 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 4 Aug 2021. 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 Saudi Arabia. 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?
Haemoglobin (time frame: after three months ( 90 days ± 7 days)). 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 4 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.