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.: PACTR202105806562705 Date of Approval: 12/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title IMPACT OF NUTRITION EDUCATION AND COUNSELLING ON NUTRITIONAL STATUS AND ANAEMIA AMONG EARLY ADOLESCENTS IN GHANA.
Official scientific title Nutrition education and counselling to improve dietary iron intake and iron status of early adolescents in Ghana
Brief summary describing the background and objectives of the trial The United Nations Population Division (2015) statistics revealed that a quarter of the world’s population is adolescents and about 90% live in developing countries (Sawyer et al., 2012). The report estimates that 19% of the population in Africa are adolescents and is expected to rise to 42% by 2030. According to Ghana Statistic Service (2018) about 38.8% of the total population in Ghana are adolescents. This shows that majority of the population is at the preceding period to adulthood. Adolescents undergo rapid physiological and physical changes that require adequate intake of micronutrients particularly iron. Iron is a critical component in cognitive performance, menarche, immunity and lean body mass formation (Pasricha et al., 2014). Ghana demographic and health survey report (2014) showed iron deficiency anaemia prevalence rate of about 48% in adolescence (15-19year). Iron deficiency is the leading cause of more than half of anemia, and increases morbidity, mortality, low birth weight and reduce work performance (W.H.O., 2016; Joshi1 & Gumashta, 2013). World Health Organization (2015) prioritized adolescent nutrition as a means to curtail or reduce critical micronutrient deficiency manifestations in poverty perpetuation, irreversible health challenges, poor pregnancy outcome and rise in mortality and morbidity in adolescents, however, most studies are skewed towards the middle and late adolescence. This study aims to: analyze the iron status such as haemoglobin, ferritin, and C-reactive protein of the early adolescent; assess their usual or actual food intake and iron status, and determine the effectiveness of iron-rich food sources on iron status.
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 02/03/2020
Actual trial start date 02/11/2020
Anticipated date of last follow up 29/09/2021
Actual Last follow-up date 15/09/2021
Anticipated target sample size (number of participants) 82
Actual target sample size (number of participants) 123
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nutrition education Nutrition education and counselling: Participants and guardians in the intervention group are met every 2 (phone conversation) to 3 (face-to-face interactions) weeks Six months Nutrition education and counselling will be given to guardians and adolescents. The counselling session is to last approxitemaly 30 minutes. Nutrition education focussed on the importance of iron, anaemia (causes, prevention and management), types of food sources of iron, sources iron-rich foods, iron-enhancing and iron-inhibiting. Nutrition charts on iron are shown to participants and guardians in the processing of counselling. Participants are also to be educated on the proper way of combining foods to ensure maximum absorption of iron in the food. Nutrition education materials are to be given to participants after the counselling. 62
Control Group No treatment N.A. Six months No intervention will be given for this group 62 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy Adolescents (early adolescents) aged 10-14 years. Adolescents living with sickle cell disease, pregnant, on any medication and severely anaemic or malnourished prior to the intervention phase Adolescent: 13 Year-18 Year,Child: 6 Year-12 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 20/01/2020 Committee on Human Research Publication and Ethics
Ethics Committee Address
Street address City Postal code Country
Kumasi Kumasi PMB Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Haemoglobin level twice: pre-and post-intervention
Secondary Outcome dietary intake, knowledge level and nutritional status-underweight Twice - pre and post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Community center Oborgu Juaso Ghana
Community center Banka Juaso Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Michael Wiafe Kumasi Kumasi Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Michael Wiafe Kumasi Kumasi Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Michael Wiafe mwiafeakenten@yahoo.ca +233200905456 Kumasi
City Postal code Country Position/Affiliation
Kumasi Ghana Kwame Nkrumah University of Science and Technology
Role Name Email Phone Street address
Public Enquiries Divine Elicophie deli-cophie@uhas.edu.gh +233243387461 Ho
City Postal code Country Position/Affiliation
Ho Ghana University of Health and Allied Sciences
Role Name Email Phone Street address
Scientific Enquiries Mary Adjepong madjepong2020@gmail.com +23366187195 Kumasi
City Postal code Country Position/Affiliation
Kumasi Ghana Kwame Nkrumah University of Science and Technology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will be password protected. Data can be accessed by the principal investigated and committee on human research publication and ethics. Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months Data for this project can be accessed by officially writing to: The Chairman Committee on Human Research, Publications and Ethics Kwame Nkrumah University of Science and Technology, School of Medical Sciences and Komfo Anokye Teaching Hospital Kumasi, Ghana. or email: chrpe@knust.edu.gh
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://doi.org/10.1177/02601060221074433 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