CompletedNot Applicable

Development, Feasibility and Acceptability of Recipes for Locally Available, Specially Formulated Foods for the Management of Moderate Acute Malnutrition in Niger (Related to NCT06382857 Protocol)

Niger30 participantsStarted 2022-08-19

Plain-language summary

The study consisted of two phases. Phase 1 was a recipe development phase, which aimed to identify recipes that meet ≥80% of the recommended nutrient profile for Specially Formulated Foods (SFF) used in the standard management of MAM and made with locally available ingredients. In Phase 2, the recipes developed during Phase 1 were evaluated for acceptability among children 6 to \< 24 months of age with MAM during a randomized crossover feeding study with a 30-minute observed test dose and evaluation of at-home use.

Who can participate

Age range

6 Months – 23 Months

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.

Inclusion Criteria: * Moderate acute malnutrition (MAM) * Eat semi-solid or solid foods for at least 30 days * Written informed consent obtained from the child's legal guardian Exclusion Criteria: * Contraindication/allergy to any locally available ingredient of the LA-SFF recipes generated in Phase 1 Recipe Development * Live outside of the study catchment area or their caregiver planned to move outside of the study catchment area in the next month * Severe acute malnutrition (SAM) * Medical complications requiring hospital based treatment

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

Observed test dose acceptability

Timeframe: During 30 minutes of test dose administration

At-home observation acceptability

Timeframe: 12 hours

Trial details

NCT IDNCT07506213

SponsorEpicentre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-11

View on ClinicalTrials.gov More Moderate Acute Malnutrition (MAM) trials