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临床试验/NCT06521151
NCT06521151已完成不适用

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.

Hawassa University2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2024年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
2
主要终点
Dietary Intake Practice

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

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:

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • .Pregnant women less and equal 12 weeks of pregnancy.

排除标准

  • Pregnant women who had been diagnosed with:-
  • Confirmed hypertension
  • Diabetes mellitus

结局指标

主要结局

Dietary Intake Practice

时间窗: 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•

次要结局

  • Adequacy of serum folate and iron(through study completion, an average of 1 week,)
  • Gestational weight gain(through study completion, an average of 1 month,)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kaleb Mayisso Rodamo

Assistant professor

Hawassa University

研究点 (2)

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