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Waterborne Diseases clinical trials

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NCT ID: NCT04209569 Completed - Nutrition Poor Clinical Trials

One Nutrition in Complex Environments (ONCE)

ONCE
Start date: January 17, 2020
Phase: N/A
Study type: Interventional

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.