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.

NCT ID: NCT06521151

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2024-10-10

Brief 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. 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.

Conditions

Nutritional Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

egg based diet and Audio based nutrition education - group (arm-1)

76 pregnant women will be recruited to receive both egg based diet and audio based nutrition education

Group Type: EXPERIMENTAL

egg based diet

Intervention Type: DIETARY_SUPPLEMENT

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).

egg based diet alone- group (arm-2),

76 pregnant women will be recruited to receive egg based diet alone

Group Type: EXPERIMENTAL

egg based diet

Intervention Type: DIETARY_SUPPLEMENT

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).

Audio based nutrition education alone -group (arm- 3).

76 pregnant women will be recruited to receive audio based nutrition education alone

Group Type: EXPERIMENTAL

egg based diet

Intervention Type: DIETARY_SUPPLEMENT

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).

control arm (Arm-4)

72 pregnant women will be employed in the control group to receive routine health education

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

egg based diet

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).

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Audio based nutrition education

Eligibility Criteria

Exclusion Criteria

• Confirmed hypertension
• Diabetes mellitus

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ethiopian Public Health Institute

OTHER_GOV

Sponsor Role: collaborator

Addis Ababa University

OTHER

Sponsor Role: collaborator

Jima university

UNKNOWN

Sponsor Role: collaborator

Hawassa University

OTHER

Sponsor Role: lead

Responsible Party

Kaleb Mayisso Rodamo

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hawassa University

Awasa, Sidama Region, Ethiopia

Countries

Ethiopia

References

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.

Reference Type: DERIVED

PMID: 40611339 (View on PubMed)

Related Links

http://amanuelyoseph45@gmail.com

my closest colligue

Other Identifiers

IRB/098/16

Identifier Type: -

Identifier Source: org_study_id