One Nutrition in Complex Environments (ONCE)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Nutrition Poor, Aflatoxins Toxicity, Water-Related Diseases

Intervention / Treatment
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* Behavioral: Nutrition Impact and Positive Practice Circle (NIPP)


Participation Criteria
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Eligibility Criteria
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The inclusion criteria: Female circle: Willingness to participate in the group staying in the area for 12 weeks. Have a child under the age of 2 (irrespective of status of malnutrition) Male circle inclusion Willingness to participate staying the area for 12 weeks Spouse, brothers and/or other influential male family members of the female caregiver enrolled in the female circle Community circle - No specific criteria other than being key community leaders Exclusion Criteria: Individuals in households without eligible children (i.e. without a child under age 2), or who will not be present in the selected communities during the intervention and data collection periods and/or who are not willing to participate through the entire 12-week cycle.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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. for the venous aflatoxin sub-study, 36 women will be purposively selected from the eligible communities.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NIPP<br>The NIPP group is a standard social behavior change (SBCC) intervention that tackles a set of underlying causes of malnutrition, with the potential to have both a curative and preventative impact on child malnutrition. The approach in this group/arm involves training and pragmatic behavior change education reinforced by practical activities over a 12-week period to both men and women in selected communities. It aims to utilize easy, viable and accessible solutions within the community that can be used to improve and protect household health and nutrition. The 12-week lesson plans for the circles are divided into 3 components, i) hands-on behavior change sessions that focus on the key pre-identified causes of malnutrition to improve awareness and practice ii) micro-gardening for improved household nutrition security and iii) participatory cooking demonstrations to stimulate improvements in nutritional status and care practices. | Behavioral: Nutrition Impact and Positive Practice Circle (NIPP)<br>* 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)<br>|
| Experimental: NIPP+<br>In addition to establishing the circles and implementing the three NIPP components also implemented in the NIPP arm, those randomized to the NIPP+ arm will be provided access to innovations to allow and encourage the households and communities to translate the knowledge into positive practices. The innovations and access to vendors who sell innovations will be made available during the training to the NIPP+ volunteers who will provide trainings and access to vendors during the circle meetings. Most of the additions will be made accessible at a subsidized/low cost. The NIPP+ officers from the program will support NIPP+ volunteers in collaboration with agricultural extension officers. | Behavioral: Nutrition Impact and Positive Practice Circle (NIPP)<br>* 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)<br>|
| No Intervention: Control<br>No Intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Aflatoxin Exposure in Maize | aflatoxin in parts per billion in a random sample of maize in a given household's maize supply | within 1-month of harvest immediately after the intervention and one year after the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in E. coli exposure in household and community water source | e. coli measured in colonies/100 ml | prior to the intervention, immediately after the intervention, and 1 year following the intervention | 
| Change in Dietary Diversity - mother and child | 24 hours recall applied to standard dietary diversity range | prior to the intervention, immediately after the intervention, and 1 year following the intervention and 2 and 6-months after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SBCC, child wasting, aflatoxin, coliform, Uganda