NCT04209569: ONCE

One Nutrition in Complex Environments (ONCE)

Completed NA Last updated 31 January 2024

What this trial tests

NA trial testing Nutrition Impact and Positive Practice Circle (NIPP) in Nutrition Poor in 1,834 participants. Completed in 30 December 2022.

Timeline

17 January 2020

Primary endpoint
30 December 2022

30 December 2022

Quick facts

Lead sponsor	Tufts University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,834
Start date	17 January 2020
Primary completion	30 December 2022
Estimated completion	30 December 2022
Sites	1 location across Uganda

Drugs / interventions tested

• Nutrition Impact and Positive Practice Circle (NIPP)

Conditions studied

• Nutrition Poor — all drugs for Nutrition Poor →
• Aflatoxins Toxicity — all drugs for Aflatoxins Toxicity →
• Water-Related Diseases — all drugs for Water-Related Diseases →

Sponsor

Tufts University

Who can join

Eligibility, any sex, with Nutrition Poor or Aflatoxins Toxicity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study asks the research question "Does enabling families (particularly mothers and other caregivers) to 'assess and act' on drivers of malnutrition through a targeted SBC+ package succeed in a sustained reduction of risk factors thereby improving child health and nutrition?" This study aims to implement and measure the effects of a multi-level multi-sectoral behavior change information intervention in Agago District of Northern Uganda and determine potential for scale up in a complex environment.

The study design is a three-arm cluster randomized controlled superiority design (cRCT) with a 1:1:1 allocation ratio. The study arms will be: Group 1: NIPP arm; Group 2: NIPP+ arm; and Group 3: Non-intervention control arm. A barrier analysis will be conducted to ensure appropriate targeting and contextualization of the NIPP and NIPP+ approaches prior to implementation. Each intervention arm will receive a 12-week intervention (NIPP or NIPP+) with active monitoring and longitudinal follow ups post intervention at 2, 6, and 12-months post-intervention. The total sample size for the Barrier Analysis will be a maximum of 450 caregivers; for the main intervention, 900 households (300/arm) will be purposely sampled from the randomly selected communities. Respondents for the qualitative portion will be purposely selected.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Impact and Sustainability of Multisector Interventions to Improve Water Quality and Food Safety in Complex Environments: A Cluster-Randomized Controlled Trial in Northern Uganda.
   Moore IG, Ren Y, Griswold S, Van Sant C, et al · · 2025 · PMID 40774242 · DOI 10.4269/ajtmh.24-0825
2. The One Nutrition in Complex Environments (ONCE) study protocol: a cluster-randomized multi-level multi-sectoral intervention to improve nutrition in Uganda.
   Griswold SP, Marshak A, Fitzpatrick M, Lantagne D, et al · · 2022 · PMID 35365180 · DOI 10.1186/s13063-022-06170-7