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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.

Not Applicable
Completed
Conditions
Nutritional Deficiency
Interventions
Dietary Supplement: egg based diet
Registration Number
NCT06521151
Lead Sponsor
Hawassa University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
76
Inclusion Criteria
  • .Pregnant women less and equal 12 weeks of pregnancy.

.

Exclusion Criteria

Pregnant women who had been diagnosed with:-

  • Confirmed hypertension
  • Diabetes mellitus

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
egg based diet alone- group (arm-2),egg based diet76 pregnant women will be recruited to receive egg based diet alone
egg based diet and Audio based nutrition education - group (arm-1)egg based diet76 pregnant women will be recruited to receive both egg based diet and audio based nutrition education
Audio based nutrition education alone -group (arm- 3).egg based diet76 pregnant women will be recruited to receive audio based nutrition education alone
Primary Outcome Measures
NameTimeMethod
Dietary Intake Practicethrough 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 Outcome Measures
NameTimeMethod
Adequacy of serum folate and ironthrough study completion, an average of 1 week,

serum level of folate and iron will be measured after dietary intervention of egg based diet during second and third trimesters of the pregnancy

Gestational weight gainthrough study completion, an average of 1 month,

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.

Trial Locations

Locations (1)

Hawassa University

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Hawassa, Sidama, Ethiopia

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