,
Lyaatu, Isaac
Mosha, Dominic
Sando, Mary Mwanyika
Jeong, Joshua
Yousafzai, Aisha
PrayGod, George
Evarist, Roman
Galvin, Lauren
Kieffer, Mary Pat
Kumalija, Elfrida
Simpson, Jennifer
Ambikapathi, Ramya
Boncyk, Morgan
Matangi, Evidence
Gunaratna, Nilupa S. http://orcid.org/0000-0003-2504-4694
Funding for this research was provided by:
1000 Days
Risk Pool Fund
Conrad N. Hilton Foundation
Eleanor Crook Foundation
Article History
Received: 22 December 2020
Accepted: 12 December 2022
First Online: 14 March 2024
Declarations
:
: Ethical approvals for this study were obtained from the Institutional Review Boards (IRBs) of the Tanzania National Institute of Medical Research (ref no. NIMR/HQ/R.8a/Vol.IX/2852, approved 20 August 2018), Harvard T.H. Chan School of Public Health (ref no. IRB18-1020, approved 27 Sept 2018), and PCI (ref no. 31, approved 18 Oct 2018). The Purdue University IRB ceded review to the Harvard T.H. Chan School of Public Health IRB. Any protocol modifications will first be approved by all participating IRBs, and updates will be made to the trial registry as appropriate. Given the nature of these community-based interventions, a data safety monitoring board was not deemed required. Severe adverse events (specifically, death of a participating child, mother, or father) are reported to all participating IRBs. Any ancillary studies will first be approved by all participating IRBs and include additional informed consent provisions as needed. Trial results will be disseminated via publication in peer-reviewed scientific journals with adherence to authorship guidelines from the International Committee of Medical Journal Editors. Results will also be disseminated through scientific conferences and stakeholder meetings as opportunities allow.Informed consent will be requested of all participants in the outcome and process evaluations. Primary caregivers will be asked to provide consent on behalf of themselves and their children. Informed written consent will be obtained after screening procedures, either via signature or a thumbprint in the presence of a witness for those who cannot sign. Participation in this study is completely voluntary for caregivers in the intervention and control groups. If caregivers are enrolled but choose to withdraw from the study at any time, they can do so without consequences. Confidentiality and respect for participants’ privacy including those who withdraw will be maintained. Only IRB-approved study investigators will have access to the data. Referrals will be administered to participants if they met any of the following conditions: (1) the child has mid-upper arm circumference (MUAC) below 11.5 cm; (2) the child has bilateral pitting edema; (3) the woman has body mass index below 16 kg/m<sup>2</sup>; (4) the woman has MUAC below 18.5 cm; (5) the man has body mass index below 16 kg/m<sup>2</sup>; (6) the man has MUAC below 18.5 cm; and (7) the woman reports intimate partner violence.
: Not applicable.
: The authors declare that they have no competing interests.