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IRCT20220508054783N1 IRCT 2022-05-29 Jimma University Effect of Intensive Nutrition Counselling on Nutritional Status of Pregnant Women Effect of Intensive Nutrition Education and Counselling Package on Nutritional Status of Pregnant Women Attending Antenatal Care Clinic. A Clustered Randomized Controlled Trial. 2022-05-20 anticipated 300 Complete https://irct.ir/trial/63448 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Randomization description: Unit of randomization will be health center. Health centers will be randomly allocated to intervention and control arms. From the total of 6 health centers, 3 are allocated to intervention groups and the rest 3 health centers are allocated to control groups. Randomization will be done after a public container ballot by a person who is not a member of this study. Cluster randomization will be used to prevent message contamination because women in the same cluster have a high probability of communicating and discussing the intervention messages. To avoid this, all eligible pregnant women in one cluster will be enrolled in the same arm (either in the intervention or control arms). Moreover, buffer zones (health center with non-adjacent catchment area) will be left between the intervention and control clusters to prevent information contamination, Blinding description: The health facilities will be invited to participate prior to randomization without disclosure of allocation status. Participants will not informed about allocation to intervention or control arm. Outcome assessors who have no information about the experiment will be deployed to measure the outcome of the intervention. N/A Not applicable. Intervention 1: The intervention group will receive the intensive nutrition education and counseling package (INECP). The intervention package contains intensive counselling by trained health care providers on promoting a healthy diet, adequate weight gain, consistent use of micro-nutrient supplements, counseling about healthy eating and deworming. Leaflets will be given and regular short message service will be sent to pregnant mothers on their mobile phones. Intervention 2: Control group: The control group will continue to receive the usual care. Yes - There is a plan to make this available What will be shared: Nutritional status of pregnant women When: January 2024 To whom: will be shared for people working in academic institutions Conditions: The data could be used for academicians, researchers and policy makers Where to obtain: Data can be obtained from Mr. Ermias Bekele Wakwoya, email: ermi3577@gmail.com How to obtain: Making request through email Comments:
public Ermias Bekele Wakwoya
Institute of Health, Jimma University, Jimma
Jimma Ethiopia 378, Jimma Universit +251 91 307 0421 ermi3577@gmail.com Jimma University scientific Ermias Bekele Wakwoya
Institute of Health, Jimma University, Jimma
Jimma Ethiopia 378, Jimma Universit +251 91 307 0421 ermi3577@gmail.com Jimma University Ethiopia Pregnant women attending antenatal care clinic in selected health institutions in East Shoa zone, Central Ethiopia. 18 years 45 years Female Pregnant women who had known medical illnesses Prevention N/A The intervention group will receive the intensive nutrition education and counseling package (INECP). The intervention package contains intensive counselling by trained health care providers on promoting a healthy diet, adequate weight gain, consistent use of micro-nutrient supplements, counseling about healthy eating and deworming. Leaflets will be given and regular short message service will be sent to pregnant mothers on their mobile phones. Control group: The control group will continue to receive the usual care. The primary outcome of the study is nutritional status of pregnant women. The nutritional status of the pregnant women will be assessed by using mid upper arm circumference measurement method. The measurement will be made before and after the intervention. Timepoint: 12 weeks after intervention. Method of measurement: The nutritional status of pregnant women will be measured by using Mid Upper Arm Circumference (MUAC). Hemoglobin level. Timepoint: 12 weeks after intervention. Method of measurement: Heamocue machine. Jimma University Approved 2021-07-24 Institutional Review Board, Institute of Health, Jimma University Institute of Health, Jimma University, Jimma Jimma Oromia Ethiopia