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.: PACTR202111813445259 Date of Approval: 02/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Improving adolescent girls consumption of pulses by nutrition education
Official scientific title Evaluation of the effectiveness of pulses-based Nutrition Education in Improving the Dietary Practices of Adolescent Girls in Northwest Ethiopia
Brief summary describing the background and objectives of the trial Background: Adolescent girls’ under-nutrition is a serious public health problem in Ethiopia, mainly due to lack of adequate protein in food table. Animal source protein foods are not affordable for the majority of Ethiopian population. There is an established recommendation that pulses food should be used as the substitute of animal origin proteins in such situations. However, studies show that its consumption is very far from the recommended quantity and quality to be benefited from its value. So, this study is designed to improve the consumption of pulses-food through model-based nutrition education in adolescent school girls in Northwest Ethiopia. Methods: A cluster randomized controlled trial will be used. The study will be conducted from Oct, 2021 to Mar, 2022. A Two groups of schools, each having two schools, will be formed and randomly assigned to intervention and control groups. Adolescent girls from the intervention school and control school will be recruited by systematic random sampling. The intervention is a nutrition education, focusing on pulses food. The education will be delivered over one month on a single 45-60 minutes session per week basis. A total of 424 participants will be recruited. Pulses consumption is the outcome variable, and will be measured by interview. 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 controlled trial; Adolescent girls; Nutrition education; Pulses food;
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 01/10/2021
Actual trial start date
Anticipated date of last follow up 01/03/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 424
Actual target sample size (number of participants)
Recruitment status Not yet 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 Nutrition education For 4 weeks with a single 45-60min session per week. One month The intervention is a pulses-based nutrition education of adolescent girls in an intervention schools or arm. The intervention school girls will receive weekly lessons for about a month after collecting base line information from both intervention and control adolescent girls. A total of four sessions, each session lasting for about 45-60 minutes will be conducted. The first session will focus on definition of under nutrition, short term and long term consequence of adolescent girls under nutrition, benefits of eating balanced diet and keeping proper dietary pattern. The second session will be about the food groups that constitute a balanced diet, which include their benefits and sources. The third session will be about introducing the common pulses, explaining the benefits of using pulses for improving nutritional status, the advantage of relaying on pulses as source of protein as substitute of meat and egg. This session will also focus on different steps of pulses food preparation: production, storage and processing; soaking, germination and boiling; pulses incorporated food preparation techniques and consumption; and proper food handling. The steps will be explained about each pulse common in the study area. All the above three sessions will be theoretical sessions, the teaching methods of which will be lectures, and group discussion aided by posters. The last session will be demonstration of what is detailed in the third session. The nutrition education will be delivered based on Pender’s Health Promotion Model (HPM) constructs/concepts. 212
Control Group Usual practice or no intervention Not applicable Simply followed for one month with out intervention Usual practice or no intervention will be delivered. 212 Uncontrolled
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 - pulses production states will be included. Participants (adolescent girls): - All adolescent girls in the selected schools Clusters (schools): - whose principal is unwilling for including the school in the study, - schools which has been or is in a nutrition program Participants (adolescent girls): who are; - Not willing to participate - Likely to leave the study area before the study completed, - Unable to communicate, - On dieting or diet restriction due to medical advice - Missing even a single session of the trainings Adolescent: 13 Year-18 Year,Adult: 19 Year-44 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 27/10/2021 Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
University of Gondar Gondar 196 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pulses consumption Pre-post measurement.
Secondary Outcome Dietary diversity score, Change in Health Promotion Model constructs, Weight change Pre-post measurement
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Schools in Northwest Ethiopia University of Gondar Gondar 196 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Gondar Maraki Gondar 196 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Gondar Main campus, University of Gondar Gondar 196 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Prof. Gashaw Andargie Main campus, University of Gondar Gondar 196 Ethiopia
Dr. Telake Azale CMHS, University of Gondar Gondar 196 Ethiopia
Dr. Netsanet Worku CMHS Gondar 196 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fantahun Ayenew Mekonnen fantahunaye@gmail.com +251929347130 Azezo
City Postal code Country Position/Affiliation
Gondar Ethiopia PhD fellow at the University of Gondar
Role Name Email Phone Street address
Public Enquiries Netsanet Work Mengistu netsanet32000@yahoo.com +251966351966 BIliko
City Postal code Country Position/Affiliation
Gondar Ethiopia Instructor at the University of Gondar
Role Name Email Phone Street address
Scientific Enquiries Telake Azale Bisetegn atelake07@gmail.com +251918771951 Chechela
City Postal code Country Position/Affiliation
Gondar Ethiopia Instructor at the University of Gondar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Sharing of the summary results will be thought. Statistical Analysis Plan,Study Protocol June, 2021 Key findings will 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