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.: PACTR202209659332435 Date of Approval: 27/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title NUTRITION EDUCATION IMPROVES KNOWLEDGE ON IRON AND FOOD INTAKE PRACTICES AMONG YOUNG ADOLESCENTS: A NON-RANDOMIZED CONTROLLED TRIAL
Official scientific title Nutrition education and counselling to improve dietary iron intake and iron status of young adolescents in Ghana.
Brief summary describing the background and objectives of the trial Adolescence is the transition from childhood to adulthood. World Health Organization (W.H.O., 2011) defines adolescence as the period between the ages of 10 and 19 years. Thus, adolescence has been categorised into early (10-14 years old), middle (15-17 years old) and late (18-21 years old). There is a rapid physical and physiological change during adolescence. The psychosocial and biological developments in the phases of adolescence have effect on life-course (W.H.O., 2015). Iron is a critical component in cognitive performance, menarche, immunity and lean body mass formation (Pasricha et al., 2014). Adolescents with poor nutritional status show nutrition deficit knowledge that influence their food choices and intake. The exercise of unacceptable social behaviours by most adolescents to gain approval from their peers has the tendency to encourage meal skipping, reduction of food intake and the absorption of some critical nutrients. The habit of skipping meals in adolescence encourages the relish of the influx of junk foods to the neglect of local nutritious foods. These adolescents with uninformed food intake or poor dietary behaviour are likely to be victims of critical micronutrient of public health concern. Iron deficiency gives indication of other micronutrients deficiencies such as vitamin C, riboflavin, vitamin B12, folate and vitamin B6. Low iron result in poor appetite and pregnancy outcomes, fatigue, dizziness and low cognitive performance. Also, micronutrients malnutrition cost the world annually about twenty-five billion dollars. The study aims assess the knowledge level of iron and food intake practice among young adolescents in Ghana.
Type of trial CCT
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 04/01/2021
Actual trial start date 01/02/2021
Anticipated date of last follow up 30/08/2021
Actual Last follow-up date 30/07/2021
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 137
Recruitment status Completed
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 Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intervention group Received nutrition education every three weeks for six months six months Nutrition education: management, prevention and consequences of anaemia, importance of iron, food sources of iron, iron-rich foods, iron-enhancing foods and iron-inhibiting foods 68
Control Group No nutrition education follow-up monthly six months Received no intervention 69 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Early adolescents (10-14years) who were healthy 2. Those who show mild and moderate iron deficiency were involved in the intervention phase. Adolescents within the age category who were: 1. Living with sickle cell 2. Pregnant 3. On any special medication 4. Severely anaemic or malnourished prior to the intervention phase* will be exempted from the study. Adolescent: 13 Year-18 Year 10 Year(s) 14 Year(s) Both
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 13/09/2022 Committee on Human Research Publication and Ethics
Ethics Committee Address
Street address City Postal code Country
KNUST Kumasi KNUST Ghana
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 20/01/2020 Committee on Human Research Publication and Ethics
Ethics Committee Address
Street address City Postal code Country
KNUST Kumasi KNUST Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome iron-rich food, iron-enhancing foods, awareness of anaemia, management, prevention and consequences of anaemia Two
Secondary Outcome Food intake practices Two
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Asante Akim South Municipality Asante Akim Juaso Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Michael Wiafe Akenteng KNUST Kumasi Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Michael Wiafe Akenteng KNUST Kumasi Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Charles Apprey appreycharles@gmail.com +233501571836 KNUST
City Postal code Country Position/Affiliation
Kumasi Ghana Lecturer Kwame Nkrumah University of Science and Technology
Role Name Email Phone Street address
Scientific Enquiries Reginald Annan reggie@imtf.org +2332011237169 KNUST
City Postal code Country Position/Affiliation
Kumasi Ghana Lecturer Kwame Nkrumah University of Science and Technology
Role Name Email Phone Street address
Public Enquiries Michael Wiafe mwiafeakenten@yahoo.ca +233200905456 KNUST
City Postal code Country Position/Affiliation
Kumasi Ghana Junior Researcher Kwame Nkrumah University of Science and Technology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data can be accessed upon reasonable request by writing to the ethics review board of KNUST, Kumasi-Ghana Study Protocol Two years Data can be accessed by the ethics review board, principal investigator and supervisors
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