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.: PACTR201905528313816 Date of Approval: 16/05/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title malnutrition among adolescents
Official scientific title effect of health education intervention on knowledge, attitude and practice of adolescent girls towards malnutrition in Maiduguri Metropolitan Council, Borno state Nigeria
Brief summary describing the background and objectives of the trial Background of the study Adolescents are young individuals that are between the ages of 10 and 19 years’ old that can be affected by malnutrition which is insufficiency, excess, or inequality in individual energy intake or nutrients. Inadequate food consumption is the greatest cause of malnutrition, the burden is increasingly becoming difficult to ignore most especially in the case of adolescent girls in underdeveloped and developing countries, this is relevant to maternal nutrition, child survival, chronic diseases, unhealthy development, affecting individual and community’s economic productivity (Black et al., 2013; WHO, 2018b). Malnutrition has become a huge global burden, its prevalence differs between nation and also within regions of the same country. In the advanced countries, overnutrition (overweight and obesity) is the major concern while undernutrition has become a major burden to the underdeveloped and developing countries(Aa & Ahmed, 2014). The adolescent stage is one of the challenging periods in life as it is the era of speedy growth and maturation from the phase of childhood to adulthood, they gain about 15 to 20% of their height, and 25 to 50% of their weight between the ages of 10 to 19 years old. Adolescent girls do not gain weight during pregnancy and lactation but rather lose weight leading to stunting, underweight and anemia, to meet their growth and development requirements there is a need to improve their knowledge, attitude, and practice on nutritional intake and healthy lifestyle through multi-sectoral health education intervention (Aa & Ahmed, 2014; Fatemeh Mokhtari, Ashraf Kazemi, 2016). objectives of the study Phase I: To determine the knowledge, attitude, and practice of adolescent girls towards malnutrition in Maiduguri Metropolitan Council (MMC). Phase II: To develop, implement and evaluate the health education intervention module in improving knowledge, attitude and practice of adolescent girls towards malnutrition
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 Prevention
Anticipated trial start date 02/05/2019
Actual trial start date
Anticipated date of last follow up 02/10/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 422
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Triple benefit Six (6) session, bi-weekly for 3 months 3 months the health education intervention will cover the following topics: Basic facts about malnutrition (definition, forms, causes, sign, and consequences of malnutrition) Basic information about food groups (macro and micronutrient), definition, classification, food source, healthy local snacks food groups by the Food and Agricultural Organisation of the united nations, dietary diversity and healthy eating habit (skipping meals and snacking) Information on water, sanitation, and hygiene (WASH) (source of water, water storage, treatment of water, hand washing, toilet hygiene, and environmental hygiene, and the F-table 212
Control Group Malaria health education intervention Once in a mont 3 months Malaria intervention was given the control group 212 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Must be a full secondary school with junior secondary school 1 (JSS) to senior secondary 3 (SS). ii. Must be either a mixed school or girl’s schools only iii. Must be a government school iv. Must be within Maiduguri Metropolitan Council (MMC) vi. Adolescent girls between the ages of 10 and 19 years old vii. Adolescent girls who can read and write i. Private schools ii. Primary schools iii. Schools mixed with married women iv Girls that are sick Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 10 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
No 07/05/2019 ministry of health education
Ethics Committee Address
Street address City Postal code Country
Borno State Government Ministry of Education, Musa Usman Secretariat, P.M.B 1046. Maiduguri Maiduguri 600215 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome knowledge, attitude, and practice. baseline, at 3 months immediately after intervention, at 3 months after intervention total of 6 months
Secondary Outcome Hygiene and food security baseline, 3 months immediately after intervention and 3 months after intervention, total of 6 months.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
JEMDOVE F-8, Kashim Shettima plaza, opposite university of Maiduguri senate building, Bama road Maiduguri Maiduguri Borno state 600230 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ruth Charles Shapu E-56 Federal Lowcost Baga road Maiduguri, Borno State Maiduguri 600282 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ruth Charles Shapu E-56 Federal Low Cost, Ibrahim Taiwo Estate, Baga Road Maiduguri, Borno State Maiduguri 600125 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof. Suriani Ismail Faculty of medicine and health sciences, university putra malaysia selangor 43400 Malaysia
Dr Norliza Ahmad Faculty of medicine and health sciences, university putra malaysia selangor 43400 Malaysia
Dr Lim Poh ying Faculty of Medicine and Health Sciences, University Putra Malaysia Selangor 43400 Malaysia
Prof Ibrahim Abubakar Njodi University of Maiduguri, Bama road Maiduguri, Borno state Maiduguri 600233 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ruth Charles Shapu ruthyshapu52@gmail.com +2348062928582 Department of public health, Faculty of medicine and health sciences, university putra malaysia, 43400, serdang
City Postal code Country Position/Affiliation
Selangor 43400 Malaysia PhD. student
Role Name Email Phone Street address
Scientific Enquiries Suriani Ismail si_suriani@upm.edu.my +60192249828 Department of Public Health Faculty of Medicine and Health Science, university putra malaysia, 43400
City Postal code Country Position/Affiliation
selangor 43400 Malaysia main supervisor
Role Name Email Phone Street address
Scientific Enquiries Lim Poying pohying_my@upm.edu.my +60125888713 Department of Public Health Faculty of Medicine and Health Science, university putra malaysia
City Postal code Country Position/Affiliation
selangor 43400 Malaysia co supervisor
Role Name Email Phone Street address
Scientific Enquiries Norliza Ahmad lizaahmad@upm.edu.my +60192710577 Department of Public Health Faculty of Medicine and Health Science, university putra malaysia
City Postal code Country Position/Affiliation
selangor 43400 Malaysia co supervisor
Role Name Email Phone Street address
Public Enquiries Ibrahim Abubakar Njodi ibrahimnjodi@gmail.com +2348023835177 Department of public health education, University of Maiduguri, Borno state
City Postal code Country Position/Affiliation
Maiduguri 600125 Nigeria co supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1. sociodemographic 13 questions 2. knowledge 28 questions 3. Attitude 17 questions 4. practice consisting of 3 sections. section 1: meal frequency, section2: frequency of food consumption using the food group 23 questions and section c: 24 hours dietary recall 5. food security 9 questions 6. Hygiene 5 question 7. information motivation behavioral skill construct 16 questions Informed Consent Form 12 months after study completion Prof suriani Ismail si_suriani@upm.edu.my
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