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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202406699274475 Date of Registration: 07/06/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluating a co-designed Adolescent Nutrition Fluency Intervention: a randomized trial in seven African countries
Official scientific title Reducing Nutrition-related Noncommunicable Diseases in Adolescence and Youth: Interventions and Policies to Boost Nutrition Fluency and Diet Quality in Africa (ARISE-NUTRINT)
Brief summary describing the background and objectives of the trial Adolescents and young adults have been neglected in surveillance efforts and health policies until recently, resulting in a lack of information on risk factors and fewer health gains in this age group than in others. As the first step towards advancing the global health agenda within this critical age group, it is necessary to fill the knowledge gap around adolescent and youth health by conducting evidence-based interventions. Specifically for Nutrition, providing context-specific information on healthy nutrition behaviors in childhood may help to prevent malnutrition and chronic, long-term health issues such as obesity, cardiovascular disease, type 2 diabetes, and stroke In response to this critical need, we will aim to gain an understanding of local nutrition and diet-related intervention needs, and will then co-design and paper prototype a context-appropriate Adolescent Nutrition Fluency Intervention (ANFI) in Burkina Faso, and subsequently adapt the ANFI to Ethiopia, Tanzania and Uganda (ANFI co-design).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ARISENUTRINT
Disease(s) or condition(s) being studied Nutrition literacy and fluency, Physical Activity ,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/05/2025
Actual trial start date
Anticipated date of last follow up 30/07/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 4800
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Adolescent Nutrition Fluency Intervention Once for pamphlets distribution and mass-media campaign Monthly for 10 months for IFA supplementation and mobile phone messaging Approximately 10 months Other than the regular health and nutrition services available in the community, the intervention group will receive a mixture of one-off interventions such as distribution of information material through pamphlets and mass-media campaign, and recurring interventions such as IFA supplementation and mobile phone messaging on related nutrition information. The specific interventions will be finalized in the formative phase of the study through the prototyping exercises and will be collaboratively designed with end-users and implementers. 2400
Control Group Adolescent Nutrition Fluency Intervention control group Regular dosage of health and nutrition services available in the community Approximately 10 months The control group will receive the regular health and nutrition services available in the community. 2400 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Participant is between the ages of 10-24 years. • Minors (i.e. less than 18 years of age): the parents or guardians provide written informed consent. • Minors: the minor participant provides informed assent. • Adults (i.e. 18 years of age and above) provides written informed consent. • Adolescents and young adults meeting one of the following criteria will be excluded from the study. • Does not meet the above-listed inclusion criteria. • Too ill to be interviewed. • With impaired cognitive capacity that may interfere in making meaningful decisions. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Child: 6 Year-12 Year 10 Year(s) 24 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 11/08/2023 Heidelberg University Faculty of Medicine Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Alte Glockengiesserei 11 Heidelberg 69115 Germany
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 25/04/2024 National Institute for MedicalResearch National HealthResearch Ethics Committee
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es Salaam 9653 United Republic of Tanzania
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 10/11/2023 Addis Continental Institute ofPublic Health InstitutionalResearch Ethics ReviewCommittee
Ethics Committee Address
Street address City Postal code Country
Ayat Homes Zone 8 Road 8 Addis Ababa 26751 Ethiopia
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 01/12/2023 Uganda National Council for Sciene and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road Ntinda Kampala 6884 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Nutrition literacy At baseline and 12-months after baseline
Secondary Outcome Dietary diversity, BMI-for-age z-score‘ and ‚hemoglobin concentration‘ At baseline and 12-months after baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Africa Academy for Public Health AAPH 6 Msonge Street, Mikocheni Dar es salaam 32273 United Republic of Tanzania
Nouna Health Research Centre CRSN Rue Namory Keita Nouna Burkina Faso
Addis Continental Institute of Public Health Ayat Zone 8 Addis Ababa Ethiopia
Makerere University School of Public Health New Mulago Hill Road, Mulago Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
European Commission Rue de la Loi 175 Brussels 1040 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor European Commission Rue de la Loi 175 Brussels 1040 Belgium Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Africa Academy for Publich Health 6 Msonge Street, Mikocheni Dar es Salaam 32273 Tanzania
Addis Continental Institute of Public Health Ayat Zone 8 Addis Ababa Ethiopia
Makerere University School of Public Health New Mulago Hill Road, Mulago Kampala Uganda
Nouna Health Research Center Rue Namory Keita Nouna Burkina Faso
Heidelberg Institute of Global Health Im Neuenheimer Feld 130/3 Heidelberg 69210 Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Till Baernighausen till.baernighausen@uni-heidelberg.de 00496221565637 Im Neuenheimer Feld130.3
City Postal code Country Position/Affiliation
Heidelberg 69210 Germany Head of Institute
Role Name Email Phone Street address
Public Enquiries Joy Mauti Akpan joy.mauti@uni-heidelberg.de 004915901816364 Im Neuenheimer Feld130.3
City Postal code Country Position/Affiliation
Heidelberg 69210 Germany Project Coordinator
Role Name Email Phone Street address
Scientific Enquiries Joy Mauti joy.mauti@uni-heidelberg.de 004915901816364 Im Neuenheimer Feld130.3
City Postal code Country Position/Affiliation
Heidelberg 69210 Germany Project Coordinator
Role Name Email Phone Street address
Principal Investigator Mary MwanyikaSando msando@aaph.or.tz 00255735166105 6 Msonge Street,Mikocheni
City Postal code Country Position/Affiliation
Dar es salaam 32273 United Republic of Tanzania Director of the Insitute
Role Name Email Phone Street address
Principal Investigator David Guwatudde dguwatudde@musph.ac.ug 00256414543872 New Mulago Hill Road, Mulago
City Postal code Country Position/Affiliation
Kampala Uganda Head of Department
Role Name Email Phone Street address
Principal Investigator Ali Sie sieali@crsn-nouna.bf 0022620537043 Rue Namory Keita
City Postal code Country Position/Affiliation
Nouna Burkina Faso Head of Institute
Role Name Email Phone Street address
Principal Investigator Yemane Berhane yemaneberhane@gmail.com 00251116390038 Ayat Zone 8
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Head of Insititute
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data from the NUTRINT intervention study without any information that could be used to identify a particular individual, will be made available upon reasonable request. Informed Consent Form,Study Protocol After completion of the intervention from 1 August 2026 to 30 July 2028 Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review by the steering committee and approval of a research proposal and Statistical Analysis Plan (SAP) as well as execution of a Data Sharing Agreement (DSA). Access to the trial will be granted after the closure of the trial.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.arise-nutrint.eu 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