--- 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." nct_id: NCT06521151 overall_status: COMPLETED phase: NA sponsor: Hawassa University study_type: INTERVENTIONAL primary_condition: Nutritional Deficiency countries: Ethiopia canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06521151.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06521151" ct_last_update_post_date: 2025-04-30 last_seen_at: "2026-05-12T06:24:04.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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. **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. **NCT ID:** [NCT06521151](https://clinicaltrials.gov/study/NCT06521151) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 76 - **Lead Sponsor:** Hawassa University - **Collaborators:** Ethiopian Public Health Institute, Addis Ababa University, Jima university - **Conditions:** Nutritional Deficiency - **Start Date:** 2024-05-31 - **Completion Date:** 2024-10-10 - **CT.gov Last Update:** 2025-04-30 ## 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. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 49 Years - **Sex:** FEMALE - **Healthy Volunteers:** Yes ``` Inclusion Criteria:- .Pregnant women less and equal 12 weeks of pregnancy. .Exclusion Criteria: Pregnant women who had been diagnosed with:- * Confirmed hypertension * Diabetes mellitus ``` ## Arms - **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 - **egg based diet alone- group (arm-2),** (EXPERIMENTAL) — 76 pregnant women will be recruited to receive egg based diet alone - **Audio based nutrition education alone -group (arm- 3).** (EXPERIMENTAL) — 76 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 ## Interventions - **egg based diet** (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). ## Primary Outcomes - **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• ## 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,)_ ## Locations (1) - Hawassa University, Awasa, Sidama Region, Ethiopia ## Recent Field Changes (last 30 days) - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.hawassa university|awasa|sidama region|ethiopia` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06521151.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06521151* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*