Clinical trial NCT06521151: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Deficiency
Keywords: Birth weight,
Lead sponsor: Hawassa University
Sponsor class: OTHER
Collaborators: name: Ethiopian Public Health Institute
name: Addis Ababa University
name: Jima university
First posted: 2024-07-25
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: PREVENTION

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 criteria: Inclusion Criteria:- .Pregnant women less and equal 12 weeks of pregnancy.

.Exclusion Criteria: Pregnant women who had been diagnosed with:-

* Confirmed hypertension
* Diabetes mellitus

Primary outcomes:
measure: Dietary Intake Practice
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: Gestational weight gain
timeFrame: through study completion, an average of 1 month,
measure: Adequacy of serum folate and iron
timeFrame: through study completion, an average of 1 week,
Other outcomes:
measure: birth weight of new borne babies
timeFrame: through study completion, an average of 1 month,
Locations:
city: Hawassa
country: Ethiopia
facility: Hawassa University
state: Sidama
Study officials:
References: