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Article History

Received: 21 March 2023

Accepted: 12 June 2023

First Online: 5 July 2023

Declarations

:

: Ethics approval was obtained from the Ethics committees of the Tokyo Women’s Medical University of Japan and Nepal Health Research Council, Nepal (#944/2019P), Kathmandu University, Nepal, and Human Resource and Ethics Committee of Central Queensland University Australia (#CQU RSH/HE 0000022453). The intervention was registered in the Australia and New Zealand Clinical Trial Registry (ANZCTR) on 06 May 2021 (ACTRN12621000531819). Privacy and confidentially of the information gathered and disseminated throughout the intervention process (via face-to-face or mobile phone) will be strictly maintained. All the investigators will be trained on research ethics involving human participants. Participants verbal and written consent will be obtained from enumerators during the data collection process. The consent will be obtained from the participants medical records and the collection of blood samples to assess Glycated Haemoglobin (HbA1c) levels. The collected data will be stored in the secure database of Kathmandu University, Nepal, and Central Queensland University, Australia. Participants’ identified information will only be available to the project staff involved with the project implementation and management. However, the personal information will be taken off from the dataset once the deidentified personal id of each participant is generated. The principal investigators and higher degree by research (HDR) students enrolled in this project will have access to deidentified data set for necessary analyses. Furthermore, upon reasonable written request to the principal investigator/s of this study, the deidentified trial data may be available for researchers to conduct further analyses such as meta-analyses.

: Not applicable

: The authors declared that they have no competing interests.