One Nutrition in Complex Environments (ONCE)

NCT04209569 | Completed

• 1 other identifier: 13426
• Study Type: interventional
• Target: 1,834
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition Poor; Aflatoxins Toxicity; Water-Related Diseases

Keywords

SBCC; child wasting; aflatoxin; coliform; Uganda

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Aflatoxin Exposure in blood serum

  immediately after the intervention, and 1 year following the intervention

• Aflatoxin Exposure in blood serum

  immediately after the intervention, and 1 year following the intervention

• 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

Other Outcomes (6)

• Change in Mid-upper Arm Circumference

  prior to the intervention, immediately after the intervention, and 1 year following the intervention

• Change in Food Insecurity

  prior to the intervention, immediately after the intervention, and 1 year following the intervention

• Change in weight-for-height z score

  prior to the intervention, immediately after the intervention, and 1 year following the intervention

Study Arms (3)

NIPP

ACTIVE COMPARATOR

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)

NIPP+

EXPERIMENTAL

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)

Control

NO INTERVENTION

No Intervention

Interventions

Nutrition Impact and Positive Practice Circle (NIPP) BEHAVIORAL

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)

NIPP; NIPP+

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts University: lead
• GOAL, Ireland: collaborator
• Centro Internacional de Mejoramiento de Maiz y Trigo Internacional, Mexico: collaborator
• Cornell University: collaborator

Study Sites (1)

GOAL/Uganda

Kampala, Uganda

Location

Related Publications (41)

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MeSH Terms

Conditions

Malnutrition; Waterborne Diseases

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Infections

Study Officials

• Stacy P Griswold, MS

  Tufts University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: December 24, 2019
• Study Start: January 17, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be made available via USAID Data Development Library after the first paper has been published.
• Access Criteria: Data will be available to the public via the Data Development Library.

Locations

UG (1)