Odukoya, Oluwakemi Ololade
Manortey, Steve
Takemoto, Michelle
Alder, Steve
Okuyemi, Kolawole S.
Funding for this research was provided by:
Fogarty International Center (K43TW010704.)
Article History
Received: 9 January 2019
Accepted: 13 April 2020
First Online: 7 May 2020
Ethics approval and consent to participate
: Ethical approval has been obtained from the Health Research and Ethics Committee of the College of Medicine, University of Lagos (CMUL/HREC/05/18/347). Only individuals who have voluntarily provided written informed will be enrolled in the study. To ensure the safety of participants and the validity and integrity of the data, a data and safety monitoring board (DSMB) will be established and meet approximately every 6 months. The DSMB will include senior investigators with expertise in research methods, statistical analysis, community health, physical activity, and nutrition. Adverse events, though unlikely, could occur if participants do not adhere to our intervention instructions for example, if a participant trips or falls while attempting to be physically active or if a participant consumes unwholesome fruits or vegetables resulting in gastroenteritis or other gastric symptoms. The study ethical protocol makes provision for the possibility of this occurrence by ensuring that participants are adequately informed and educated to prevent possible adverse events. Participants will also be advised on the appropriate actions to take should they occur. These events, should they occur, will be reported to the Health Research and Ethics Committee of the College of Medicine, University of Lagos and their recommendations will be taken.
: Not applicable
: The authors declare that they have no competing interests.