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.

NCT06521151 | Completed DMC

• 1 other identifier: IRB/098/16
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Keywords

Birth weight,

Outcome Measures

Primary Outcomes (1)

• 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•

  through study completion, an average of 1 month

Secondary Outcomes (2)

• Gestational weight gain

  through study completion, an average of 1 month,

• Adequacy of serum folate and iron

  through study completion, an average of 1 week,

Other Outcomes (1)

• birth weight of new borne babies

  through study completion, an average of 1 month,

Study Arms (4)

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

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

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

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

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).

Also known as: Audio based nutrition education

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)

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Confirmed hypertension
• Diabetes mellitus

Sponsors & Collaborators

• Hawassa University: lead
• Ethiopian Public Health Institute: collaborator
• Addis Ababa University: collaborator
• Jima university: collaborator

Study Sites (1)

Hawassa University

Awasa, Sidama Region, 105, Ethiopia

Location

Related Publications (1)

• 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.

  PMID: 40611339 DERIVED

Related Links

• my closest colligue

MeSH Terms

Conditions

Malnutrition; Birth Weight

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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:
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: July 25, 2024
• Study Start: May 31, 2024
• Primary Completion: September 10, 2024
• Study Completion: October 10, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: September /2025

Locations

ET (1)