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.: PACTR202407500217236 Date of Approval: 15/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Improving Dietary and Health Data for Decision-Making in Agriculture and Nutrition Actions in Africa
Official scientific title Improving Dietary and Health Data for Decision-Making in Agriculture and Nutrition Actions in Africa
Brief summary describing the background and objectives of the trial Malnutrition is one of the most used indicators for tracking progress towards attainment of Sustainable Development Goal 2 (SDG2) and the impacts of development interventions. Unfortunately, the current methods for collecting nutritional indicators require considerable training, are slow and are expensive to collect data accurately. In this project, we developed and tested a mobile smartphone-based platform called Mbiotisho which means our health in Samburu, one of the local languages in Kenya), by which households can easily collect, submit and access information on their and their children’s nutritional status in near-real time and at extremely low cost. The objective of this study is to test if respondents change feeding and consumption behavior in response to tracking and tailored advice generated by comparing self-reported measurements with guidelines.
Type of trial Observational
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 Physical activity and nutrition
Anticipated trial start date 01/10/2019
Actual trial start date 15/10/2019
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 31/12/2020
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 198
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
Single Group Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pretreatment child treatment caregiver treatment Six weeks before the first information intervention was launched. Child feedback: After the first six weeks, then the child feedback and tracking feature was launched. This continued until the end of the project (10 months) Caregiver feedback: The second intervention was launched in June of 2020 and was available through the end of the program, December 31, 2020. We developed a smartphone application that caregivers used to record and submit information on their health and nutrition and the same for their children. For the first six weeks of the project, the application was only used to record and submit data. The child feedback and tracking feature provided the caregiver with feedback on the reported child consumption. The caregiver feedback provided the caregiver with feedback on her consumption. 198
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Caregivers from Samburu East subcounty in Kenya between the age of 18 and 55 years old that were the primary caregiver for a child age 4-58 months at the time of registration and were already working with their local community health volunteer. Participants needed to attend the orientation meeting and training period and needed to consent to the project to be included. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 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 04/06/2019 International Livestock Research Institute Institutional Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P.O. Box 30709 00100 Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Child: A binary variable that is equal to one if the child met the Minimum Dietary Diversity threshold for children ages 6-23 months, calculated according to WHO 2008. in every submission, which could be as much as daily.
Primary Outcome Adult: Consumption of animal source foods, dark green leafy vegetables, orange fleshed fruits and vegetables in the last 24 hours. These outcomes were selected for their importance for women of reproductive age (WHO 2016). In every submission, as much as daily
Secondary Outcome None None
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lolkuniyiani Community Health Unit East Samburu Sub-county Samburu County Kenya
Lodungokwe Community Health Unit East Samburu Sub-county Samburu County Kenya
Lorubae Community Health Unit East Samburu Sub-county Samburu County Kenya
Sordo Namnyak Community Health Unit East Samburu Sub-county Samburu County Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
IDRC 150 Kent Street Ottawa K1G3H9 Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor FANRPAN 141 Cresswell Road Pretoria 0184 South Africa FANRPAN is an all-inclusive multi-stakeholder pan-African network that provides independent evidence to inform and influence policy processes at national and regional levels.
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Nathaniel Jensen njensen@ed.ac.uk 447592936985 Easter Bush Campus
City Postal code Country Position/Affiliation
Edinburgh EH259RG United Kingdom Senior research fellow
Role Name Email Phone Street address
Public Enquiries Nathaniel Jensen njensen@ed.ac.uk 447592936985 Easter Bush Campus
City Postal code Country Position/Affiliation
Edinburgh EH259RG United Kingdom Senior Research Fellow
Role Name Email Phone Street address
Principal Investigator Simbarashe Sibanda ssibanda@fanrpan.org 27128042966 141 Cresswell Road
City Postal code Country Position/Affiliation
Pretoris 0127 South Africa Nutrition Sensitive Agriculture Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The following was the data management plan approved by our ethics committee at ILRI and by the The data will be collected using a smartphone application, which will then sync to a Firebase Google Server. Those data will be accessible only by the PI. The PI will download the data and anonymize it before our ILRI research team (Oscar Naibei and Vincent Alulu) or the FANRPAN team will have access to it. We note that the data was not made public because the location and date stamps on the data combined with the child age and respondent age are a main value of the data. If we were to scrub the data of these identifying data, they are just a bunch of random food security measurements. Researchers can gain access to the data by requesting access from the PI and then signing a non-disclosure agreement with either ILRI or FANRPAN. Study Protocol Researchers can gain access to the data by requesting access from the PI and then signing a non-disclosure agreement with either ILRI or FANRPAN. The data will be shared with researchers that complete a non-disclosure agreement with either ILRI or FANRPAN.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 25/06/2024 01/06/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 25/06/2024 Result - 25/06/2024 Result - 25/06/2024 Result - 25/06/2024 Result - 25/06/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information