Nutritional DeficiencyNCT06521151
The Effect of Audio Based Nutrition Education on Dietary Intake Practice, and Egg-based Diet Intervention on Nutrient Adequacy, and Gestational Weight Gain Among Pregnant Women and Newborn's Birth Weights in the North Sidama Zone, Ethiopia.
A study testing egg based diet in people with Nutritional Deficiency, run by Hawassa University at 1 site in Ethiopia.
Trial summary
Background: Inadequate intake and utilization of nutrients during pregnancy is associated with inadequate nutrient adequacy and it has central implications on subsequent suboptimal weight gain and has an increased risk on low birth weight. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nutritional Deficiency
- What is being tested?
- egg based diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEthiopia
- Study dates
- 31 May 2024to 10 Oct 2024
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Inclusion Criteria:- .Pregnant women less and equal 12 weeks of pregnancy.
.Exclusion Criteria: Pregnant women who had been diagnosed with:-
- Confirmed hypertension
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Audio Based Nutrition Education on Dietary Intake Practice, and Egg-based Diet Intervention on Nutrient Adequacy and Gestational Weight Gain Among Pregnant Women and Newborn's Birth Weights in the North Sidama Zone, Ethiopia.
Background: Inadequate intake and utilization of nutrients during pregnancy is associated with inadequate nutrient adequacy and it has central implications on subsequent suboptimal weight gain and has an increased risk on low birth weight. Likewise, majority of Ethiopian pregnant women have inadequate nutrient intakes. These may be due to their poor dietary habits. Nutrition education is well-established intervention to enhance optimal dietary practices and is crucial to design appropriate diet interventions like multiple micronutrient and protein-energy supplements to optimize pregnancy outcomes.
However, in this country, integration of nutrition education with intervention of essential nutrients during pregnancy is not well studied. Therefore, this study is designed to measure the effect of nutrition education and egg-based diet interventions on dietary intake practice, nutrient adequacy, and gestational weight gain among pregnant women, and newborn's birth weight in North Sidama Zone.
Read more
Materials and methods: These studies will employee mixed study designs sequentially to address each specific objective. Baseline survey: A mixed method comprising community-based cross-sectional quantitative study complemented with a descriptive qualitative study that will be conducted in three woredas of North Sidama Zone in February 2024 to assess barriers and facilitators on the intake of adequate nutrients among pregnant women.
Following the baseline survey, four-arm cluster- randomized controlled trial (cRCT) will be conducted to evaluate the effectiveness of nutrition education and egg-based diet interventions on dietary intake practice, nutrient adequacy, and gestational weight gain among pregnant women and birth weight from March to August 2024. A total of 300 pregnant women will be selected randomly from participants of the baseline survey, and enrolled in four arms in a 1:1:1:1 allocation ratios: A multi-level mixed-effect logistic regression model will be used for quantitative data analysis, and a paired and independent t-test will be employed to measure the mean change in dietary intake practice, gestational weight gain and nutrient density between intervention and control groups. The qualitative data will be analyzed using Atlas-Ti software according to the inductive thematic content analysis approach.
Budget and work plan: For this study 1,102,200 ETB will be required. The study will be funded by Norad Project, Hawassa University, Sidama Regional Government and other possible grants in future. The study period will be March to August 2024.
- Conditions
- Nutritional Deficiency
- Being tested
- egg based diet
- Keywords
- Birth weight,
- Medical subject headings
- Malnutrition, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
egg based dietDietary supplement
Also called Audio based nutrition education
egg based diet and audio based nutrition education group (arm-1), egg based diet alone group (arm-2), and audio based nutrition education alone group (arm- 3).
| Study group | Role | What they receive |
|---|---|---|
| egg based diet and Audio based nutrition education - group (arm-1) | Experimental | 76 pregnant women will be recruited to receive both egg based diet and audio based nutrition education Receives: Dietary Supplement: egg based diet |
| egg based diet alone- group (arm-2), | Experimental | 76 pregnant women will be recruited to receive egg based diet alone Receives: Dietary Supplement: egg based diet |
| Audio based nutrition education alone -group (arm- 3). | Experimental | 76 pregnant women will be recruited to receive audio based nutrition education alone Receives: Dietary Supplement: egg based diet |
| control arm (Arm-4) | No intervention | 72 pregnant women will be employed in the control group to receive routine health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary Intake Practice
Dietary intake practice of pregnant women will be measured through assessing traditional and cultural beliefs (dietary intake habits, rituals, beliefs, values), pregnant woman's lifestyle (physical activity (type/frequency), alcohol intake and smoking practice, frequency of dining out, previous diet education, interest in dietary change, medicine use, usual and current appetite, weight history and meal pattern will be measured after delivery of audio based and banner prepared nutrition messages two times a month starting from second until the end of third trimester of pregnancy amongst pregnant women using standardized questionnaires•
Measured: through study completion, an average of 1 month
Secondary outcomes (2)
Gestational weight gain
Gestational weight will be assessed through measuring the weight of the women using platform beam balance scale with movable weights or on a high-quality electronic scale. The scale should be graduated to the nearest 100 g (0.25 lb) and calibrated periodically against a known weight or series of weights approximating the range of weights encountered in clinic patients. The fewer clothes the better, as long as the weight of the clothing can be kept relatively constant for all women and all seasons of the year. This requires weighing women without purses, shoes, boots, coats, jackets, or any accompanying young children. All personnel responsible for taking weights and other measurements will be trained in the standard procedures. Optimal weight gain will be classified as: Normal weight women gain 17-25 kg at term, overweight women should gain 14-23 kg at term and obese women should gain 11-19 kg at term.
Measured: through study completion, an average of 1 month,
Adequacy of serum folate and iron
serum level of folate and iron will be measured after dietary intervention of egg based diet during second and third trimesters of the pregnancy
Measured: through study completion, an average of 1 week,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start31 May 2024
- Primary completion10 Sep 2024
- Study completion10 Oct 2024
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 Nutritional DeficiencyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following the baseline survey, four-arm cluster- randomized controlled trial (cRCT) will be conducted to evaluate the effectiveness of nutrition education and egg-based diet interventions on dietary intake practice, nutrient adequacy, and gestational weight gain among pregnant women and birth weight
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawassa University
- Sponsor type
- University, hospital or other
- Collaborators
- Ethiopian Public Health Institute, Addis Ababa University, Jima university
- Responsible party
- Principal investigator, Kaleb Mayisso Rodamo, Hawassa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521151
- Sponsor's protocol ID
- IRB/098/16
- Status last verified
- Apr 2025
- First submitted
- 2 Jun 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all will be available up on resealable requested
Publications
Mayisso K, Bosha T, Tamiru D. Effect of nutrition intervention coupled with healthy dietary advice on the nutritional status of pregnant women in the northern zone of the Sidama region, Ethiopia: a multilevel, cluster randomized controlled trial. J Health Popul Nutr. 2025 Jul 3;44(1):230. doi: 10.1186/s41043-025-00968-2.
PubMed 40611339
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Audio Based Nutrition Education on Dietary Intake Practice, and Egg-based Diet Intervention on Nutrient Adequacy and Gestational Weight Gain Among Pregnant Women and Newborn's Birth Weights in the North Sidama Zone, Ethiopia.
- ClinicalTrials.gov ID
- NCT06521151
- Acronym / sponsor ID
- IRB/098/16
- Conditions
- Nutritional Deficiency
- Keywords
- Birth weight,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hawassa UniversityUniversity, hospital or other
- Collaborators
- Ethiopian Public Health Institute, Addis Ababa University, Jima university
- Study start
- 31 May 2024 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 25 Jul 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.
Background: Inadequate intake and utilization of nutrients during pregnancy is associated with inadequate nutrient adequacy and it has central implications on subsequent suboptimal weight gain and has an increased risk on low birth weight. Likewise, majority of Ethiopian pregnant women have inadequate nutrient intakes. These may be due to their poor dietary habits. Nutrition education is well-established intervention to enhance optimal dietary practices and is crucial to design appropriate diet interventions like multiple micronutrient and protein-energy supplements to optimize pregnancy outcomes.
However, in this country, integration of nutrition education with intervention of essential nutrients during pregnancy is not well studied. Therefore, this study is designed to measure the effect of nutrition education and egg-based diet interventions on dietary intake practice, nutrient adequacy, and gestational weight gain among pregnant women, and newborn's birth weight in North Sidama Zone.
Materials and methods: These studies will employee mixed study designs sequentially to address each specific objective. Baseline survey: A mixed method comprising community-based cross-sectional quantitative study complemented with a descriptive qualitative study that will be conducted in three woredas of North Sidama Zone in February 2024 to assess barriers and facilitators on the intake of adequate nutrients among pregnant women.
Following the baseline survey, four-arm cluster- randomized controlled trial (cRCT) will be conducted to evaluate the effectiveness of nutrition education and egg-based diet interventions on dietary intake practice, nutrient adequacy, and gestational weight gain among pregnant women and birth weight from March to August 2024. A total of 300 pregnant women will be selected randomly from participants of the baseline survey, and enrolled in four arms in a 1:1:1:1 allocation ratios: A multi-level mixed-effect logistic regression model will be used for quantitative data analysis, and a paired and independent t-test will be employed to measure the mean change in dietary intake practice, gestational weight gain and nutrient density between intervention and control groups. The qualitative data will be analyzed using Atlas-Ti software according to the inductive thematic content analysis approach.
Budget and work plan: For this study 1,102,200 ETB will be required. The study will be funded by Norad Project, Hawassa University, Sidama Regional Government and other possible grants in future. The study period will be March to August 2024.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Following the baseline survey, four-arm cluster- randomized controlled trial (cRCT) will be conducted to evaluate the effectiveness of nutrition education and egg-based diet interventions on dietary intake practice, nutrient adequacy, and gestational weight gain among pregnant women and birth weight
| Arm | Type | Receives |
|---|---|---|
| egg based diet and Audio based nutrition education - group (arm-1) | Experimental | Dietary Supplement: egg based diet76 pregnant women will be recruited to receive both egg based diet and audio based nutrition education |
| egg based diet alone- group (arm-2), | Experimental | Dietary Supplement: egg based diet76 pregnant women will be recruited to receive egg based diet alone |
| Audio based nutrition education alone -group (arm- 3). | Experimental | Dietary Supplement: egg based diet76 pregnant women will be recruited to receive audio based nutrition education alone |
| control arm (Arm-4) | No intervention | –72 pregnant women will be employed in the control group to receive routine health education |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| egg based dietAlso: Audio based nutrition educationegg based diet and audio based nutrition education group (arm-1), egg based diet alone group (arm-2), and audio based nutrition education alone group (arm- 3). | Dietary supplement | Audio based nutrition education alone -group (arm- 3)., egg based diet alone- group (arm-2),, egg based diet and Audio based nutrition education - group (arm-1) |
Primary outcome
Dietary Intake Practice
Time frame: through study completion, an average of 1 month
Dietary intake practice of pregnant women will be measured through assessing traditional and cultural beliefs (dietary intake habits, rituals, beliefs, values), pregnant woman's lifestyle (physical activity (type/frequency), alcohol intake and smoking practice, frequency of dining out, previous diet education, interest in dietary change, medicine use, usual and current appetite, weight history and meal pattern will be measured after delivery of audio based and banner prepared nutrition messages two times a month starting from second until the end of third trimester of pregnancy amongst pregnant women using standardized questionnaires•
2 secondary outcomes
Gestational weight gain
Time frame: through study completion, an average of 1 month,
Adequacy of serum folate and iron
Time frame: through study completion, an average of 1 week,
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 30 Apr 2025.
- Derived from this study: PubMed 40611339Mayisso K, Bosha T, Tamiru D. Effect of nutrition intervention coupled with healthy dietary advice on the nutritional status of pregnant women in the northern zone of the Sidama region, Ethiopia: a multilevel, cluster randomized controlled trial. J Health Popul Nutr. 2025 Jul 3;44(1):230. doi: 10.1186/s41043-025-00968-2.
- my closest colligueLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all will be available up on resealable requested
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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 egg based diet in people with Nutritional Deficiency, run by Hawassa University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 30 Apr 2025. 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 Ethiopia. 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?
Dietary Intake Practice (time frame: through study completion, an average of 1 month). 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 NCT06521151, 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 30 Apr 2025.