CompletedNot Applicable

One Nutrition in Complex Environments (ONCE)

Uganda1,834 participantsStarted 2020-01-17

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Aflatoxin Exposure in Maize

Timeframe: within 1-month of harvest immediately after the intervention and one year after the intervention.

Change in E. coli exposure in household

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

Trial details

NCT IDNCT04209569

SponsorTufts University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-30

View on ClinicalTrials.gov More Nutrition Poor trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.