One Nutrition in Complex Environments (ONCE)

Sponsor

Tufts University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04209569

Collaborator

GOAL, Ireland (Other), Centro Internacional de Mejoramiento de Maiz y Trigo Internacional, Mexico (Other), Cornell University (Other)

1,836

Enrollment

Location

Arms

68.4

Anticipated Duration (Months)

26.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nutrition Poor Aflatoxins Toxicity Water-Related Diseases	Behavioral: Nutrition Impact and Positive Practice Circle (NIPP)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1836 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jan 17, 2020

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Sep 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: NIPP 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) 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)
Experimental: NIPP+ 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) 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)
No Intervention: Control No Intervention

Arm

Intervention/Treatment

Active Comparator: NIPP

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)

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)

Experimental: NIPP+

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)

No Intervention: Control

No Intervention

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Change in Mid-upper Arm Circumference [prior to the intervention, immediately after the intervention, and 1 year following the intervention]
cm of mid upper arm circumference taken with standard UNICEF tape
Change in Food Insecurity [prior to the intervention, immediately after the intervention, and 1 year following the intervention]
Household food insecurity and access score (0-27, 72=highly insecure)
Change in weight-for-height z score [prior to the intervention, immediately after the intervention, and 1 year following the intervention]
weight taken with SECA scale and height taken with standard height board applied to WHO growth charts

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.