NCT04209569

One Nutrition in Complex Environments (ONCE)

One Nutrition in Complex Environments (ONCE), a Cluster-randomized Trial of Nutrition Education and Access to Simple Supportive Technologies in Improving Agricultural Practices and Water Quality Management

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,834 (actual)
• Sponsor: Tufts University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Objective: 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. Intervention: Through a collaboration between Tufts University, GOAL International, CIMMYT, and Cornell University, GOAL will implement Nutrition Impact and Positive Practice (NIPP) circles as the standard SBC intervention against which the hypotheses will be tested. GOAL will also implement a NIPP+ approach which will integrate additional interventions for water, sanitation, and hygiene (WASH), and use of improved agriculture inputs. These interventions will be measured by outcome indicators measuring aflatoxin exposure, water contamination, and knowledge transferred to action. Design: 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. Analysis: This longitudinal study will collect data from all participants at 3 time points: baseline, endline, and sustainability (12-months post-intervention). The analysis will utilize Intent-to-Treat (ITT) approach using the initial randomization of the treatment arms. Using ITT will allow us to determine the overall impact of having the NIPP vs. NIPP+ vs. control, thus better mimicking real world program implementation and impact. Mixed effects models will be used to determine the role of time-variant and invariant individual (by gender) household, and community characteristics, as well as measures of exposure and integration on key outcome indicators. A difference-in-difference analysis (baseline/endline, baseline/sustainability, endline/sustainability) will also be used to triangulate findings. Sub-study: a subset of reproductive age women will be purposively selected for enrollment into a validation sub-study that will examine the level of aflatoxin (AFB1-lysine concentration) exposure measured in venous blood compared to capillary blood compared to the innovative SAFE-phone method. This will serve as a validation and calibration sub-study to gauge the accuracy of the SAFE-Phone method compared to venous reference.

Conditions

• Nutrition Poor
• Aflatoxins Toxicity
• Water-Related Diseases

Interventions

Type	Name	Description
BEHAVIORAL	Nutrition Impact and Positive Practice Circle (NIPP)	GOAL's NIPP approach is a gendered, grass-roots SBC approach, tackling a package of underlying behavioral determinants of malnutrition, irrespective of the particular manifestation. The approach is multi-sectoral in nature. It also has a strong monitoring, evaluation and adaptive learning component by design. The intervention approach (based on GOAL's NIPP approach) involves the creation of community, male and female circles in each community with messaging and activities targeted towards the three groups in varying intensities. While the male and female circles meet 2-3 times per week for a maximum period of 12 weeks while the community circles will meet for approximately three hours at any one time over a period of 2-7 days. (See GOAL NIPP Implementation Guidelines)

Timeline

• Start date: 2020-01-17
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2019-12-24
• Last updated: 2024-01-31

Locations

1 site across 1 country: Uganda