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Open Access 01-12-2022 | Nutrition | Study protocol

The One Nutrition in Complex Environments (ONCE) study protocol: a cluster-randomized multi-level multi-sectoral intervention to improve nutrition in Uganda

Authors: Stacy P. Griswold, Anastasia Marshak, Merry Fitzpatrick, Daniele Lantagne, Kate Shoenmakers, Marlene Hebie, Anne Radday, Hugo De Groote, Saurabh Mehta, Greg Gottlieb, Patrick Webb, Shibani Ghosh

Published in: Trials | Issue 1/2022

Abstract

Objective

To implement and measure the effects of a multi-level multi-sectoral social behavior change (SBC) intervention in Agago District of Northern Uganda and to determine the potential for scale-up.

Intervention

Compare the Nutrition Impact and Positive Practice (NIPP) approach to a NIPP+ approach. The NIPP approach involves nutrition education and SBC, whereas the NIPP+ adds agricultural inputs, training, and tools to support improved farm and water quality practices. The intervention effect will be measured through lower levels of aflatoxin in grain, lower water contamination, and improved knowledge on nutrition and health.

Design

This is a three-arm cluster-randomized controlled superiority trial (cRCT). The study arms include the following: group 1: NIPP; group 2: NIPP+, and group 3: control. Groups 1 and 2 will receive a 12-week intervention (NIPP or NIPP+) with active monitoring and longitudinal follow-up at 2, 6, and 12 months post-intervention. Additionally, an in-depth process and performance evaluation of each intervention arm will be undertaken using quantitative and qualitative methods. A total of 60 clusters from 5 subcounties of the Agago district will be randomly selected, and 15 households per cluster will be recruited using specific inclusion/exclusion criteria for a total of 900 households (300/arm). Respondents for the qualitative portion will be purposely selected.

Analysis

We will collect data from all participants at 3 time points: baseline, endline, and 12 months post-intervention. The analysis will utilize intent-to-treat (ITT) using the initial randomization of the treatment arms to determine the overall impact of having the NIPP vs. NIPP+ vs. control. Mixed effects models will be used to determine the role of time-variant and invariant individual household, and community characteristics, as well as measures of exposure and integration on key outcome indicators. A difference-in-difference analysis (baseline/endline, baseline/12 months post-intervention, endline/12 months post-intervention) will also be used to triangulate findings.

Trial registration

NCT04209569. One Nutrition in Complex Environments (ONCE) Registered 24 December 2019

Available only for authorised users

While it is possible that the male and female circles may not overlap, the intervention endeavors to identify and recruit households that are assigned to the circles. There are likely to be single-headed households which will be included and will need to be considered within the context of the study implementation.

Most inputs are available at low cost and can be sourced in Uganda. We will provide some subsidies but the aim is to get all households to consider these innovations as worthy investments. For example, the hygrometer costs $0.90 per unit and can be used for many years as long as the household/farmer understands the importance and how to use the meter.

Hygrometers are battery operated and we have been able to purchase them for about $0.90 per unit through an online reseller. The device is reusable and can detect moisture levels in maize within 15 min and allows farmers and traders to determine whether or not maize is dry enough to be safely stored for later human consumption

USAID WASH Plus defines small doable actions as small or baby steps to get closer to the ideal or desired WASH behavior.

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Title: The One Nutrition in Complex Environments (ONCE) study protocol: a cluster-randomized multi-level multi-sectoral intervention to improve nutrition in Uganda
Authors: Stacy P. Griswold
Anastasia Marshak
Merry Fitzpatrick
Daniele Lantagne
Kate Shoenmakers
Marlene Hebie
Anne Radday
Hugo De Groote
Saurabh Mehta
Greg Gottlieb
Patrick Webb
Shibani Ghosh
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Nutrition
Climate Change
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06170-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

The One Nutrition in Complex Environments (ONCE) study protocol: a cluster-randomized multi-level multi-sectoral intervention to improve nutrition in Uganda

Abstract

Objective

Intervention

Design

Analysis

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Objective

Intervention

Design

Analysis

Trial registration

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