Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202111605102515 Date of Approval: 12/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Improving under-nutrition through pulses-based nutrition education
Official scientific title Dietary practice and nutritional status and the respective of pulses-based nutrition education among adolescent girls in Northwest Ethiopia.
Brief summary describing the background and objectives of the trial Background: Adolescent girls’ under-nutrition is associated with significant morbidity and, mortality, further perpetuating cycle of malnutrition in generations. In Ethiopia, adolescent girls’ problem of under-nutrition has already been recognized to be an important public health problem. However, evidence related to efficient alternative solutions to support government efforts is limited in the country. There are plenty of evidences that a nutrition education based on population’s context is an efficient intervention to improving adolescent girls’ nutrition. Objective: To evaluate the effectiveness of pulses-based nutrition education in improving the nutritional status of adolescent girls’ in Northwest Ethiopia Methods: A three arm cluster randomized controlled trial will be employed. The study will be conducted among adolescent girls in Northwest Ethiopia from Nov 2021 to April, 2022. Clusters will be first stratified into urban and rural and then assigned into intervention and control groups. Adolescent girls from the respective schools will be recruited by systematic random sampling until the required sample size is attained. A total of 639 participants based on a one two one ratio basis will be recruited. The intervention is a nutrition education, focusing on pulses food. The education will be delivered over 4-6 weeks on a single 45-60 minutes session per week basis. Reduction in underweight is the outcome variable, and will be measured by anthropometric measurements. The study will have pre-and-post measurements. Multilevel logistic regression model will be employed. Relative risks with the respective confidence intervals and p-values will be calculated. A variable having a p-value < 0.05 will be considered statistically significant. Keywords: Cluster randomized trial; Adolescent girls; Nutrition education; Pulses food; Underweight.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 20/11/2021
Actual trial start date
Anticipated date of last follow up 20/04/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 639
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pulses based nutrition education One 45-60 minutes education session per week 6weeks Pulses based nutrition education-comprehensive nutrition education followed by pulses food focused nutrition education (pulses food nutrient content, importance, advantage in growth and development and preparation) 213
Control Group Usual dietary practice No intervention No intervention Control groups will not receive an intervention. They will continue with their usual dietary practice throughout the study. 213 Dose Comparison
Control Group General Nutrition education One 45-60 minute session 4weeks General nutrition education focusing on food groups, recommended meal adequacy, frequency and and pattern, and balanced diet and their advantage. 213 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Clusters (schools) - Schools located in districts with comparable food security, and pulses production states will be included. Participants: All adolescent girls in the selected schools Clusters: whose principal is unwilling for including the school in the study, schools which has been or is in a nutrition program will be excluded. Participants: Adolescent girls who are willing to participate, and likely to leave the study area before the study completed, unable to communicate, on dieting or diet restriction due to medical advice will be excluded, missing even a single session of the trainings. Adolescent: 13 Year-18 Year 15 Year(s) 19 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/06/2020 Institutional Ethical Review Board of University of Gondar
Ethics Committee Address
Street address City Postal code Country
University of Gondar, 196 Gondar 196 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Underweight pre-post measurement
Secondary Outcome • Pulses consumption • Pender’s model constructs • Dietary diversity score • Stunting Pre-post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Schools Central Gondar Gondar 196 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Gondar University of Gondar, 196 Gondar 196 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Univeristy of Gondar University of Gondar Gondar 196 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Prof. Gashaw Andargie University of Gondar Gondar 196 Ethiopia
Dr. Telake Azale University of Gondar Gondar 196 Ethiopia
Dr Netsanet Worku University of Gondar Gondar 196 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fantahun Ayenew Mekonnen fantahunaye@gmail.com +251929347130 University of Gondar
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia University of Gondar
Role Name Email Phone Street address
Public Enquiries Gashaw Andargie Bikes gashawab@gmail.com +251911385423 University of Gondar
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia University of Gondar
Role Name Email Phone Street address
Scientific Enquiries Netsanet Worku Alemayehu netsanet32000@yahoo.com +251911941866 University of Gondar
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia University of Gondar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results will be shared Informed Consent Form,Statistical Analysis Plan,Study Protocol April 2022 Personnel identify variables will not be shared
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information