One Nutrition in Complex Environments (ONCE)

Nutrition Poor Clinical Trial

— ONCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04209569
• Other study ID #: 13426
• Status: Completed
• Phase: N/A
• Start date: January 17, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2024
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1834
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aflatoxins Toxicity
• Malnutrition
• Nutrition Poor
• Water-Related Diseases
• Waterborne Diseases

Intervention

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)

Locations

Country	Name	City	State
Uganda	GOAL/Uganda	Kampala

Sponsors (4)

Lead Sponsor	Collaborator
Tufts University	Centro Internacional de Mejoramiento de Maiz y Trigo Internacional, Mexico, Cornell University, GOAL, Ireland

Country where clinical trial is conducted

Uganda, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Mid-upper Arm Circumference	cm of mid upper arm circumference taken with standard UNICEF tape	prior to the intervention, immediately after the intervention, and 1 year following the intervention
Other	Change in Food Insecurity	Household food insecurity and access score (0-27, 72=highly insecure)	prior to the intervention, immediately after the intervention, and 1 year following the intervention
Other	Change in weight-for-height z score	weight taken with SECA scale and height taken with standard height board applied to WHO growth charts	prior to the intervention, immediately after the intervention, and 1 year following the intervention
Other	Maize production	acreage planted	just before exposure to the training and 1 year after training
Other	Maize production	production levels (kg)	just before exposure to the training and 1 year after training
Other	Maize production	yield (kg/acre)	just before exposure to the training and 1 year after training
Primary	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.
Primary	Change in E. coli exposure in household	e. coli measured in colonies/100 ml	prior to the intervention, immediately after the intervention, and 1 year following the intervention
Secondary	Aflatoxin Exposure in blood serum	venous total (ng/ml) AFB1-lysine adduct concentrations	immediately after the intervention, and 1 year following the intervention
Secondary	Aflatoxin Exposure in blood serum	albumin normalized (pg/mg) AFB1-lysine adduct concentrations	immediately after the intervention, and 1 year following the intervention
Secondary	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