One Nutrition in Complex Environments (ONCE) (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

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.

Study Overview

• Status: Completed
• Conditions: Nutrition Poor; Aflatoxins Toxicity; Water-Related Diseases
• Intervention / Treatment: Behavioral: Nutrition Impact and Positive Practice Circle (NIPP)

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 Type: Interventional
• Enrollment (Actual): 1834
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • GOAL/Uganda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No Intervention
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)

What is the study measuring?

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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Aflatoxin Exposure in blood serum	venous total (ng/ml) AFB1-lysine adduct concentrations	immediately after the intervention, and 1 year following the intervention
Aflatoxin Exposure in blood serum	albumin normalized (pg/mg) AFB1-lysine adduct concentrations	immediately after the intervention, and 1 year following the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Maize production	acreage planted	just before exposure to the training and 1 year after training
Maize production	production levels (kg)	just before exposure to the training and 1 year after training
Maize production	yield (kg/acre)	just before exposure to the training and 1 year after training

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: Cornell University; GOAL, Ireland; Centro Internacional de Mejoramiento de Maiz y Trigo Internacional, Mexico
• Investigators: Study Director: Stacy P Griswold, MS, Tufts University

Publications and helpful links

General Publications

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• Baoua I.B., Amadou L., Ousmane B., Baributsa D. and Murdock L.L. PICS bags for post-harvest storage of maize grain in West Africa. J. Stored Prod. Res., 58 (2014), pp. 20-28
• Bauby, AL. and Flachenberg, F. 2014. Achieving sustainability: linking CLTS with other approaches - an example of a thorough WASH intervention in South Eastern Chad. IN: Shaw, R.J., Anh, N.V. and Dang, T.H. (eds). Sustainable water and sanitation services for all in a fast changing world: Proceedings of the 37th WEDC International Conference, Hanoi, Vietnam, 15- 19 September 2014, 5pp
• Channa H., Ricker-Gilbert J., De Groote H., Marenya P., Bauchet J., Woloshuk C. Assessing Kenyan farmers and traders demand for low cost moisture meters to reduce aflatoxin in maize. Research brief by Purdue University and CIMMYT Kenya.
• Angood C, Khara T, Dolan C, Berkley JA; WaSt Technical Interest Group. Research Priorities on the Relationship between Wasting and Stunting. PLoS One. 2016 May 9;11(5):e0153221. doi: 10.1371/journal.pone.0153221. eCollection 2016.
• Dangour AD, Watson L, Cumming O, Boisson S, Che Y, Velleman Y, Cavill S, Allen E, Uauy R. Interventions to improve water quality and supply, sanitation and hygiene practices, and their effects on the nutritional status of children. Cochrane Database Syst Rev. 2013 Aug 1;(8):CD009382. doi: 10.1002/14651858.CD009382.pub2.
• Danso J.K., Osekre E.A., Opit G.P., Manu N., Armstrong P., Arthur F.H., Campbell J.F., Mbata G., and McNeill S.G. Post-harvest insect infestation and mycotoxin levels in maize markets in the Middle Belt of Ghana Journal of Stored Products Research 77 (2018) 9-15
• Davis Jr., Thomas P. Barrier Analysis Facilitator's Guide: A Tool for Improving Behavior Change Communication in Child Survival and Community Development Programs, Washington, D.C.: Food for the Hungry. (2004).
• ENN. Child wasting and stunting: time to overcome the separation. A Briefing Note for policy makers and programme implementers. Emergency Nutrition Network. June 2018.
• FTF NIL Africa 2013. Baseline Report. Assessing the linkage between agriculture, food security, nutrition and health among women and children in rural Ugandan households. 66 pages. www.nutritioninnovationlab.org
• GOAL. 2016. "Implementation guidelines for Nutrition Impact and Positive Practice (NIPP) approach." GOAL, Ireland
• Harding KL, Aguayo VM, Webb P. Factors associated with wasting among children under five years old in South Asia: Implications for action. PLoS One. 2018 Jul 3;13(7):e0198749. doi: 10.1371/journal.pone.0198749. eCollection 2018.
• Headey D, Nguyen P, Kim S, Rawat R, Ruel M, Menon P. Is Exposure to Animal Feces Harmful to Child Nutrition and Health Outcomes? A Multicountry Observational Analysis. Am J Trop Med Hyg. 2017 Apr;96(4):961-969. doi: 10.4269/ajtmh.16-0270. Epub 2016 Dec 19.
• Khara T, Dolan C. The relationship between wasting and stunting, policy, programming and research implications. Technical Briefing paper. Oxford, UK: Emergency Nutrition Network, 2014. 2.
• Kikafunda JK, Walker AF, Collett D, Tumwine JK. Risk factors for early childhood malnutrition in Uganda. Pediatrics. 1998 Oct;102(4):E45. doi: 10.1542/peds.102.4.e45.
• Korich DG, Mead JR, Madore MS, Sinclair NA, Sterling CR. Effects of ozone, chlorine dioxide, chlorine, and monochloramine on Cryptosporidium parvum oocyst viability. Appl Environ Microbiol. 1990 May;56(5):1423-8. doi: 10.1128/aem.56.5.1423-1428.1990.
• Kosinski KC, Kulinkina AV, Abrah AF, Adjei MN, Breen KM, Chaudhry HM, Nevin PE, Warner SH, Tendulkar SA. A mixed-methods approach to understanding water use and water infrastructure in a schistosomiasis-endemic community: case study of Asamama, Ghana. BMC Public Health. 2016 Apr 14;16:322. doi: 10.1186/s12889-016-2976-2.
• Lauer JM, Duggan CP, Ausman LM, Griffiths JK, Webb P, Agaba E, Nshakira N, Tran HQ, Gewirtz AT, Ghosh S. Biomarkers of maternal environmental enteric dysfunction are associated with shorter gestation and reduced length in newborn infants in Uganda. Am J Clin Nutr. 2018 Oct 1;108(4):889-896. doi: 10.1093/ajcn/nqy176.
• Lauer JM, Duggan CP, Ausman LM, Griffiths JK, Webb P, Bashaasha B, Agaba E, Turyashemererwa FM, Ghosh S. Unsafe Drinking Water Is Associated with Environmental Enteric Dysfunction and Poor Growth Outcomes in Young Children in Rural Southwestern Uganda. Am J Trop Med Hyg. 2018 Dec;99(6):1606-1612. doi: 10.4269/ajtmh.18-0143.
• Lauer JM, Duggan CP, Ausman LM, Griffiths JK, Webb P, Wang JS, Xue KS, Agaba E, Nshakira N, Ghosh S. Maternal aflatoxin exposure during pregnancy and adverse birth outcomes in Uganda. Matern Child Nutr. 2019 Apr;15(2):e12701. doi: 10.1111/mcn.12701. Epub 2018 Oct 23.
• Luby SP, Rahman M, Arnold BF, Unicomb L, Ashraf S, Winch PJ, Stewart CP, Begum F, Hussain F, Benjamin-Chung J, Leontsini E, Naser AM, Parvez SM, Hubbard AE, Lin A, Nizame FA, Jannat K, Ercumen A, Ram PK, Das KK, Abedin J, Clasen TF, Dewey KG, Fernald LC, Null C, Ahmed T, Colford JM Jr. Effects of water quality, sanitation, handwashing, and nutritional interventions on diarrhoea and child growth in rural Bangladesh: a cluster randomised controlled trial. Lancet Glob Health. 2018 Mar;6(3):e302-e315. doi: 10.1016/S2214-109X(17)30490-4. Epub 2018 Jan 29.
• Marshak A, Young H, Bontrager EN, Boyd EM. The Relationship Between Acute Malnutrition, Hygiene Practices, Water and Livestock, and Their Program Implications in Eastern Chad. Food Nutr Bull. 2017 Mar;38(1):115-127. doi: 10.1177/0379572116681682. Epub 2016 Dec 8.
• Marshak, A., H. Young, and A. Radday, Water, Livestock, and Malnutrition: Findings from an Impact Assessment of 'Community Resilience to Acute Malnutrition' Programming in the Dar Sila Region of Eastern Chad, 2012-2015. 2016, Feinstein International Center, Tufts University: Medford, MA.
• Marshak, A., Mazurana, D., Opio, J., Gordon, R., and T. Atim. Tracking change in livelihoods, service delivery, and governance: evidence form a 2013-2015 panel survey in Uganda. ODI Working paper 59. September 2017.
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• Vetter TR, Mascha EJ. Defining the Primary Outcomes and Justifying Secondary Outcomes of a Study: Usually, the Fewer, the Better. Anesth Analg. 2017 Aug;125(2):678-681. doi: 10.1213/ANE.0000000000002224.
• Wilson, T. 2007. Perceptions, practices, principles and policies in provision of livestock-water in Africa. Agricultural Water Management, 90 (2007), pp. 1-12
• Young H., Marshak A. Persistent Global Acute Malnutrition. A discussion paper on the scope of the problem, its drivers and recommendations for policy, practice and research. USA: Feinstein International Center, Tufts University, 2018.
• Griswold SP, Marshak A, Fitzpatrick M, Lantagne D, Shoenmakers K, Hebie M, Radday A, De Groote H, Mehta S, Gottlieb G, Webb P, Ghosh S. The One Nutrition in Complex Environments (ONCE) study protocol: a cluster-randomized multi-level multi-sectoral intervention to improve nutrition in Uganda. Trials. 2022 Apr 1;23(1):244. doi: 10.1186/s13063-022-06170-7.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2020
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: December 8, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Uganda; SBCC; child wasting; aflatoxin; coliform
• Additional Relevant MeSH Terms: Infections; Nutrition Disorders; Malnutrition; Waterborne Diseases
• Other Study ID Numbers: 13426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This is undecided, presently
• IPD Sharing Time Frame: The data will be made available via USAID Data Development Library after the first paper has been published.
• IPD Sharing Access Criteria: Data will be available to the public via the Data Development Library.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No