Pregnancy Nutritional DiseaseNCT04415450
Effect of Nutrition Education on Knowledge and Healthy Dietary Practice Among Pregnant Women
A study testing Nutrition Education counseling in people with Pregnancy Nutritional Disease, run by Orotta College of Medicine and Health Sciences at 1 site in Eritrea.
Trial summary
Healthy pregnancy and birth outcomes is greatly influenced by the intake of adequate and balanced nutrition. Pregnant women's nutritional knowledge and practice have been identified as an important prerequisites for their proper nutritional intake. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Nutritional Disease
- What is being tested?
- Nutrition Education counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteEritrea
- Study dates
- 31 Aug 2018to 24 Sep 2018
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women who were on their first and second trimester of pregnancy and willing to participate in the study were included
Who cannot join
- Pregnant women who were sick at the time of the study and those who cannot communicate verbally.
Trial locations and contacts
1 site in 1 country.
Eritrea1 site
OCMHS
Asmara, Maekel Region, 10549
About this study
Official title: Effect of Nutrition Education by Health Professionals on Pregnancy Specific Nutrition Knowledge and Healthy Dietary Practice Among Pregnant Women in Asmara, Eritrea
Healthy pregnancy and birth outcomes is greatly influenced by the intake of adequate and balanced nutrition. Pregnant women's nutritional knowledge and practice have been identified as an important prerequisites for their proper nutritional intake. The antenatal period with the opportunities for regular contact with health professionals appears to be the ideal time and setting to institute the intervention which could maximize pregnant women's outcome and that of their baby by motivating them to make nutritional changes. The overall objective of the research was to assess the effect of nutrition education on the appropriate nutritional knowledge and practice of pregnant women.
Read the detailed description
Adequate and balanced nutrition during gestation has been recognized as a prerequisite for a healthy pregnancy and birth outcomes and this is significantly determined by their nutritional knowledge and practice. This facility based single group pre-post quasi experimental study design was conducted with the objective of assessing the effect of nutrition education on the appropriate nutritional knowledge and practice of pregnant women. The study was conducted in five health facilities providing ANC (Antenatal Care) service in Asmara on 226 pregnant women. A predesigned and pretested questionnaire was used to collect data regarding nutritional knowledge via interview by trained data collectors during the pretest, immediate posttest and six weeks later. This study showed that the current intervention generally was effective in accomplishing improved knowledge and practice level of pregnant women. The simple nutrition education messages given to pregnant women using holistic approach of targeting all the major determinants in a sustained manner played a huge role in increasing their knowledge regarding nutrition during pregnancy. Knowledge regarding duration of iron supplementation was very low in this study. At the same time minor knowledge gap was seen in the sources of main food groups among pregnant women. The provided nutrition education also helped the pregnant women to improve dietary intake during pregnancy, although their adherence to iron supplements was decreased. Skipping meals and avoiding certain food items was also evident in this study. A reassuring concept is that food taboos and cultural factors were never the reasons that prevented women from consuming the food items. The educational intervention has shown more positive impact on increasing the scores regarding knowledge of appropriate nutrition during pregnancy for primigravida mothers than for multigravida mothers while the improvement in the dietary practice had no interaction with their socio-demographic characteristics. To sum up, attenuation of maternal and infant malnutrition may not be remote if pregnant women are well educated and counseled about nutrition during pregnancy. The study was conducted under limitations of not being able to control the possible effect of other sources like Television, books, magazines and radio broadcasting on the change in the knowledge and practice of pregnant women towards nutrition could not be controlled. Face to face interview may lead to social desirability bias which may in turn bring higher proportion of correct practice among pregnant women on the follow-up questioning (as the practice is self-reported).
- Conditions
- Pregnancy Nutritional Disease
- Being tested
- Nutrition Education counseling
- Keywords
- Nutrition education, Knowledge, Practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Education counselingBehavioural
In the context of health education program, an educational intervention was developed by the research team based on a training module. The nutrition education contained introductory messages and focused on meanings of healthy diet, eating a variety of food, eating well with the locally available food, hazards of maternal malnutrition, important supplements to be taken during pregnancy, harmful substances to be avoided, and measures of alleviating common discomforts associated with nutrition during pregnancy. The training program was carried out in the form of counseling using printed materials and flip charts for pictorial representation. Self-reading of leaflets containing the core messages for every topic prepared in the native language of the participants was also employed as the women in the study had one each.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Education Group | Experimental | The experimental group is the group who received the intervention which is the nutrition education and counseling. Phase I of the data collection from the experimental group which is the pregnant women (baseline assessment) using a questionnaire immediately before receiving nutrition counseling from their ANC providers first took place. Health professionals then started providing nutrition education to pregnant women preselected and assessed before the intervention. Immediate post education evaluation of the pregnant women was done by the same questionnaire used to assess in the pretest. Phase II or post intervention data collection of pregnant women was done after the client was appointed for 6 weeks after the counseling session. Receives: Behavioral: Nutrition Education counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
knowledge level of pregnant women on nutrition and their appropriate nutrition-related practice after intervention
The two outcome variables in this study were the knowledge level of pregnant women and their appropriate nutrition-related practice after intervention. At the Data set of pregnant women the categorical data from the knowledge part of the data collection was recorded to dichotomous data of 1 and 0, where 1 is having the correct answer and 0 is for incorrectly answering. Practice components of the questionnaire of pregnant women were dichotomized to 1 and 0 as well, where 1 is having good practice and 0 is having no practice. Composite scores of knowledge and practice of each pregnant woman was computed. Mean scores of the knowledge (at pre, immediate post and 6 weeks later) and practice (at pre and 6 weeks later) of pregnant women were then calculated. The pregnancy specific NEC was the independent variable in this study. Co-variables on ANC clients were the demographics characteristics addition to source of information and frequency of ANC visits.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start31 Aug 2018
- Primary completion22 Sep 2018
- Study completion24 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy Nutritional DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pregnant women who were on their first and second trimester of pregnancy
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orotta College of Medicine and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lidia Ghirmai, Orotta College of Medicine and Health Sciences
- Investigators
- Lidia G Teweldemedhin, MSc, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415450
- Sponsor's protocol ID
- OCMHS
- Status last verified
- Jun 2020
- First submitted
- 23 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not have plans to share my IPD
Publications
Daba G, Beyene F, Fekadu H, Garoma W: Assessment of knowledge of pregnant mothers on maternal nutrition and associated factors in Guto Gida Woreda, East Wollega Zone, Ethiopia. Journal of Nutrition & Food Sciences 2013, 3(6):1.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutrition Education by Health Professionals on Pregnancy Specific Nutrition Knowledge and Healthy Dietary Practice Among Pregnant Women in Asmara, Eritrea
- ClinicalTrials.gov ID
- NCT04415450
- Acronym / sponsor ID
- OCMHS
- Conditions
- Pregnancy Nutritional Disease
- Keywords
- Nutrition education, Knowledge, Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Orotta College of Medicine and Health SciencesUniversity, hospital or other
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 22 Sep 2018 (actual)
- Study completion
- 24 Sep 2018 (actual)
- First posted
- 4 Jun 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.
Healthy pregnancy and birth outcomes is greatly influenced by the intake of adequate and balanced nutrition. Pregnant women's nutritional knowledge and practice have been identified as an important prerequisites for their proper nutritional intake. The antenatal period with the opportunities for regular contact with health professionals appears to be the ideal time and setting to institute the intervention which could maximize pregnant women's outcome and that of their baby by motivating them to make nutritional changes. The overall objective of the research was to assess the effect of nutrition education on the appropriate nutritional knowledge and practice of pregnant women.
Detailed description
Adequate and balanced nutrition during gestation has been recognized as a prerequisite for a healthy pregnancy and birth outcomes and this is significantly determined by their nutritional knowledge and practice. This facility based single group pre-post quasi experimental study design was conducted with the objective of assessing the effect of nutrition education on the appropriate nutritional knowledge and practice of pregnant women. The study was conducted in five health facilities providing ANC (Antenatal Care) service in Asmara on 226 pregnant women. A predesigned and pretested questionnaire was used to collect data regarding nutritional knowledge via interview by trained data collectors during the pretest, immediate posttest and six weeks later. This study showed that the current intervention generally was effective in accomplishing improved knowledge and practice level of pregnant women. The simple nutrition education messages given to pregnant women using holistic approach of targeting all the major determinants in a sustained manner played a huge role in increasing their knowledge regarding nutrition during pregnancy. Knowledge regarding duration of iron supplementation was very low in this study. At the same time minor knowledge gap was seen in the sources of main food groups among pregnant women. The provided nutrition education also helped the pregnant women to improve dietary intake during pregnancy, although their adherence to iron supplements was decreased. Skipping meals and avoiding certain food items was also evident in this study. A reassuring concept is that food taboos and cultural factors were never the reasons that prevented women from consuming the food items. The educational intervention has shown more positive impact on increasing the scores regarding knowledge of appropriate nutrition during pregnancy for primigravida mothers than for multigravida mothers while the improvement in the dietary practice had no interaction with their socio-demographic characteristics. To sum up, attenuation of maternal and infant malnutrition may not be remote if pregnant women are well educated and counseled about nutrition during pregnancy. The study was conducted under limitations of not being able to control the possible effect of other sources like Television, books, magazines and radio broadcasting on the change in the knowledge and practice of pregnant women towards nutrition could not be controlled. Face to face interview may lead to social desirability bias which may in turn bring higher proportion of correct practice among pregnant women on the follow-up questioning (as the practice is self-reported).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pregnant women who were on their first and second trimester of pregnancy
| Arm | Type | Receives |
|---|---|---|
| Nutrition Education Group | Experimental | Behavioral: Nutrition Education counselingThe experimental group is the group who received the intervention which is the nutrition education and counseling. Phase I of the data collection from the experimental group which is the pregnant women (baseline assessment) using a questionnaire immediately before receiving nutrition counseling from their ANC providers first took place. Health professionals then started providing nutrition education to pregnant women preselected and assessed before the intervention. Immediate post education evaluation of the pregnant women was done by the same questionnaire used to assess in the pretest. Phase II or post intervention data collection of pregnant women was done after the client was appointed for 6 weeks after the counseling session. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pregnant women who were on their first and second trimester of pregnancy and willing to participate in the study were included
Key exclusion criteria (1 listed)
- Pregnant women who were sick at the time of the study and those who cannot communicate verbally.
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 |
|---|---|---|
| Nutrition Education counselingIn the context of health education program, an educational intervention was developed by the research team based on a training module. The nutrition education contained introductory messages and focused on meanings of healthy diet, eating a variety of food, eating well with the locally available food, hazards of maternal malnutrition, important supplements to be taken during pregnancy, harmful substances to be avoided, and measures of alleviating common discomforts associated with nutrition during pregnancy. The training program was carried out in the form of counseling using printed materials and flip charts for pictorial representation. Self-reading of leaflets containing the core messages for every topic prepared in the native language of the participants was also employed as the women in the study had one each. | Behavioural | Nutrition Education Group |
Primary outcome
knowledge level of pregnant women on nutrition and their appropriate nutrition-related practice after intervention
Time frame: 6 weeks
The two outcome variables in this study were the knowledge level of pregnant women and their appropriate nutrition-related practice after intervention. At the Data set of pregnant women the categorical data from the knowledge part of the data collection was recorded to dichotomous data of 1 and 0, where 1 is having the correct answer and 0 is for incorrectly answering. Practice components of the questionnaire of pregnant women were dichotomized to 1 and 0 as well, where 1 is having good practice and 0 is having no practice. Composite scores of knowledge and practice of each pregnant woman was computed. Mean scores of the knowledge (at pre, immediate post and 6 weeks later) and practice (at pre and 6 weeks later) of pregnant women were then calculated. The pregnancy specific NEC was the independent variable in this study. Co-variables on ANC clients were the demographics characteristics addition to source of information and frequency of ANC visits.
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 Jun 2020.
- BackgroundDaba G, Beyene F, Fekadu H, Garoma W: Assessment of knowledge of pregnant mothers on maternal nutrition and associated factors in Guto Gida Woreda, East Wollega Zone, Ethiopia. Journal of Nutrition & Food Sciences 2013, 3(6):1.
- Individual participant dataSharing planned: No. I do not have plans to share my IPD
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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.
Lidia G Teweldemedhin, MSc principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Education counseling in people with Pregnancy Nutritional Disease, run by Orotta College of Medicine and Health Sciences at 1 site in Eritrea.
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 1 inclusion and 1 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 Jun 2020. 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 Eritrea. 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?
knowledge level of pregnant women on nutrition and their appropriate nutrition-related practice after intervention (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04415450, which also lists 1 linked publication.
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 Jun 2020.