Effect of Intensive Nutrition Education and Counselling Package on Nutritional Status of Pregnant Women Attending Antenatal Care Clinic. A Clustered Randomized Controlled Trial.
To assess the effect of intensive nutrition education and counseling package on nutritional status during pregnancy
Design
Clustered randomized control trial will be used and the study will be carried out in East Shoa Zone, Ethiopia. A total of 150 pregnant women will be assigned to each arm. It is a multi-center study conducted in six health centers.
Settings and conduct
The study will be conducted in East Shewa Zone in Oromia regional state, Central Ethiopia. The study will take place in 6 health centers of East Shoa Zone, central Ethiopia. The study participants and the outcome assessors will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria - All pregnant women attending antenatal care clinic at the selected health centers
Exclusion criteria - Pregnant women who have preexisting medical illnesses.
Intervention groups
The intervention given for the intervention group is Intensive Nutrition Education and Counseling Package (INECP) which has 4 components that aimed at improving the nutritional status of pregnant mothers attending antenatal care service at intervention arm health facilities.
Main outcome variables
Nutritional status and hemoglobin level of pregnant women.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220508054783N1
Registration date:2022-05-29, 1401/03/08
Registration timing:retrospective
Last update:2022-05-29, 1401/03/08
Update count:0
Registration date
2022-05-29, 1401/03/08
Registrant information
Name
Ermias Wakwoya
Name of organization / entity
Jimma University
Country
Ethiopia
Phone
+251 91 207 0148
Email address
ermi3577@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-20, 1401/02/30
Expected recruitment end date
2022-05-27, 1401/03/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Intensive Nutrition Education and Counselling Package on Nutritional Status of Pregnant Women Attending Antenatal Care Clinic. A Clustered Randomized Controlled Trial.
Public title
Effect of Intensive Nutrition Counselling on Nutritional Status of Pregnant Women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women attending antenatal care clinic in selected health institutions in East Shoa zone, Central Ethiopia.
Exclusion criteria:
Pregnant women who had known medical illnesses
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board, Institute of Health, Jimma University
Street address
Institute of Health, Jimma University, Jimma
City
Jimma
Postal code
378, Jimma Universit
Approval date
2021-07-24, 1400/05/02
Ethics committee reference number
212021
Health conditions studied
1
Description of health condition studied
Not applicable
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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)
Secondary outcomes
1
Description
Hemoglobin level
Timepoint
12 weeks after intervention
Method of measurement
Heamocue machine
Intervention groups
1
Description
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.
Category
Prevention
2
Description
Control group: The control group will continue to receive the usual care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fentale Health center
Full name of responsible person
Temam Haji Bedaso
Street address
Fentale Health center
City
Mata Hara
Postal code
04, Meta Hara, Ethio
Phone
+251 91 077 0811
Email
matiblessed@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jimma University
Full name of responsible person
Melese Niguse
Street address
Jimma University
City
Jimma
Postal code
378, Jimma Universit
Phone
+251 91 710 5735
Email
meleseniguse@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jimma University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Jimma University
Full name of responsible person
Ermias Bekele Wakwoya
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Institute of Health, Jimma University, Jimma
City
Jimma
Province
Oromia
Postal code
378, Jimma Universit
Phone
+251 91 307 0421
Email
ermi3577@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jimma University
Full name of responsible person
Ermias Bekele Wakwoya
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Institute of Health, Jimma University, Jimma
City
Jimma
Province
Oromia
Postal code
378, Jimma Universit
Phone
+251 91 307 0421
Email
ermi3577@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Jimma University
Full name of responsible person
Ermias Bekele Wakwoya
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Institute of Health, Jimma University, Jimma
City
Jimma
Province
Oromia
Postal code
378, Jimma Universit
Phone
+251 91 307 0421
Email
ermi3577@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Nutritional status of pregnant women
When the data will become available and for how long
January 2024
To whom data/document is available
will be shared for people working in academic institutions
Under which criteria data/document could be used
The data could be used for academicians, researchers and policy makers
From where data/document is obtainable
Data can be obtained from Mr. Ermias Bekele Wakwoya, email: ermi3577@gmail.com
What processes are involved for a request to access data/document