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.: PACTR202311633215529 Date of Approval: 09/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of nutrition education on knowledge, attitude, practice and nutritional status of school adolescent girls in rural areas of Dale district, Sidama Region, Ethiopia
Official scientific title Effect of school-based Nutrition Education in improving Nutrition knowledge, attitude, dietary practice and Nutrional status of school adolescent girls in rural area of Dalle District, sidama region, Ethiopia.
Brief summary describing the background and objectives of the trial As defined by World Health Organization (WHO) adolescent is period of life from 10 to 19 years of age (WHO, 2017). There are 1.8 billion adolescents worldwide, or about 20% of the world's population, between the ages of 10 and 19 years. 90% of them reside in low- and middle-income (LMICs) countries. Poor nutrition among adolescent girls poses critical health risk on future pregnancy and birth outcomes especially in developing countries. During adolescence nutritional care is key because there is increased physical growth, brain development, their eating patterns and lifestyles, their risk-taking behaviors, and their susceptibility to environmental influences, hormonal change and increased nutrients requirement for growth and development. General objectives To evaluate the effect of nutrition education on nutrition knowledge, attitude, practice and nutritional status among adolescent girls in rural areas of Dale district, Sidama Region, Ethiopia. Specific objectives The specific objectives of the study were to:- • Evaluate the effect of nutrition education intervention on nutritional knowledge of adolescent girl in study area. • Evaluate the effect of nutrition education on nutritional attitude among adolescent girl in study area. • Measure the effect of nutrition education intervention on dietary practice among adolescent girls in study area. • Assess the effect of nutrition education on nutritional status among adolescent girls in study area.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) KAP
Disease(s) or condition(s) being studied Malnutrition ,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/07/2023
Actual trial start date 10/07/2023
Anticipated date of last follow up 31/10/2023
Actual Last follow-up date 10/11/2023
Anticipated target sample size (number of participants) 136
Actual target sample size (number of participants) 136
Recruitment status Closed to recruitment,follow-up continuing
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group education intervention school Four months nutrition education sessions for 4 months , three times per month was provided for participants (adolescent girls) in selected Keble’s School (intervention group). For intervention group, education intervention was given based on Health Belief Model theory. The value of educational programs depends on their effectiveness, which depends mainly on the correct use of theories and models in health education . The NE school implemented a nutrition education program that includes performing in-class nutrition education (lecture), organizing peer support activities, group discussion and disseminating nutrition information brochures. 68
Control Group Control school intervention Four months For the control group, nutrition education was given by health extension workers jointly with principal investigator based on the general usual nutrition education which is currently provided by Health extension workers. 68 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Elementary school adolescent girl students (grade 7th and 8th) from selected government school aged 10 to 19 years who willingly agreed to be part in the study were included. -And those who did not intend to transfer schools during the intervention period were included. -Those adolescent girls with obvious physical deformities for anthropometric measurements . - Absences in the pre-test, post-test and drop out during intervention time. -And also who are pregnant and lactating adolescent girl (if exists) were excluded. -Any adolescents who attended less than 25% of the nutrition education session. Adolescent: 13 Year-18 Year 13 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 11/07/2023 Hawassa University college of Medicine and Health science Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Hawassa- Ethiopia Hawassa 05 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - Nutrition knowledge, nutrition attitude, dietary practice June 4/2023
Secondary Outcome nutritional status Oct 25/2023
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dale Yirgalem, kebele 02 Yirgalem Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Salary Hawassa, sidama Hawassa Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Abraham welisa Hawassa,Sidama Hawassa Ethiopia Individual
COLLABORATORS
Name Street address City Postal code Country
Zelalem Tafese Hawassa,Sidama,Ethiopia Hawassa Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abraham Welisa abrahamwelisa@gmail.com +251922124350 Hawassa, SidamaEthiopia
City Postal code Country Position/Affiliation
Hawassa Ethiopia Civil servant
Role Name Email Phone Street address
Scientific Enquiries Zelalem Tafese wudasiez@gmail.com +251911479506 Hawassa,Sidama
City Postal code Country Position/Affiliation
Hawassa Ethiopia Lecturer
Role Name Email Phone Street address
Scientific Enquiries Alemneh Kabeta alemneh33@gmail.com +251910101982 Hawassa,Sidama
City Postal code Country Position/Affiliation
Hawassa Ethiopia Lecturer
Role Name Email Phone Street address
Scientific Enquiries Dereje Getahun derew36@gmail.com +215916158809 Hawassa
City Postal code Country Position/Affiliation
Hawassa Ethiopia Lecture
Role Name Email Phone Street address
Public Enquiries Desalegn Gaga desalegngaga2013@gmail.com +251916137533 Hawassa
City Postal code Country Position/Affiliation
Hawassa Ethiopia civil servant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in sickle cell anemia. Data or samples shared will be coded and on approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party/individual. Clinical Study Report,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Anyone who wishes to access the data and those requested by qualified researchers engaging in independent scientific research, and will be provided following review and and execution of a Data Sharing Agreement (DSA).
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