Skip to content

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)

Development, Feasibility and Acceptability of Recipes for Locally Available, Specially Formulated Foods for the Management of Moderate Acute Malnutrition in Niger: a Randomized Crossover Feeding Study With Home-use Evaluation

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07506213
Acronym
LAF
Enrollment
30
Registered
2026-04-01
Start date
2022-08-19
Completion date
2022-11-11
Last updated
2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate Acute Malnutrition (MAM)

Keywords

LAF, MAM, Moderate acute malnutrition, wasting, locally available foods, supplementary food, specially formulated foods, Niger, linear programming, lipid-based nutrient supplements, acceptability

Brief 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.

Interventions

OTHERLocally Available Food

Phase 1 of the present study developed supplementary food recipes using locally available, non-perishable ingredients. Market surveys identified 49 foods, reduced to 30 suitable items. Using linear programming in the Cost of the Diet software, 24 recipes meeting ≥80% of the nutrient profile for standard MAM treatment were generated, each including 2 g of micronutrient powder. A 2022 market survey in Maradi assessed prices and year-round availability; only six recipes met this requirement and were selected. A standardized method for at-home preparation of each recipe was developed.

Sponsors

Epicentre
Lead SponsorOTHER
Harvard School of Public Health (HSPH)
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

Participants, caregivers, and study staff were not blinded to recipe identity due to the nature of the intervention.

Intervention model description

The study had two phases. * Phase 1 (Recipe Development) focused on developing supplementary food recipes using locally available, non-perishable ingredients. Market surveys identified 49 foods, reduced to 30 suitable items. Using linear programming in the Cost of the Diet software, 24 recipes meeting ≥80% of the nutrient profile for standard MAM treatment were generated, each including 2 g of micronutrient powder. A 2022 market survey in Maradi assessed prices and year-round availability; only six recipes met this requirement and were selected. A standardized method for at-home preparation was developed. * In Phase 2 (Recipe Evaluation), six recipes developed in Phase 1 were tested in a randomized crossover study among children 6-\<24 months with MAM. The six recipes were evaluated over two days using an observed test dose at a health center, and the most acceptable recipe from the observed test dose was further evaluated during two days of at-home use.

Eligibility

Sex/Gender
ALL
Age
6 Months to 23 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Observed test dose acceptabilityDuring 30 minutes of test dose administrationConsumption of ≥ 75% of the 50 g test dose within 30 minutes
At-home observation acceptability12 hoursConsumption of ≥ 75% of the caregiver-prepared recipe within the 12-hour observation period

Secondary

MeasureTime frameDescription
Observed test dose consumptionDuring 30 minutes of test dose administrationConsumption (defined as grams of food provided at the start of the test dose minus grams of food left at the conclusion of the test dose)
Observed test dose recipe organoleptic ratingsFollowing completion of the 30-minute test dose periodTaste, smell, odor, color, and overall as reported by the caregiver on a 5-point Likert scale (1 = "dislike a lot" and 5 = "like a lot").
Observed test dose perceived child likingFollowing completion of the 30-minute test dose periodPerceived child liking as reported by the caregiver on a 5-point Likert scale (1 = "dislike a lot" and 5 = "like a lot")
At-home observation recipe organoleptic ratings12 hours (7AM - 7PM on at-home observation day)Taste, smell, odor, color, and overall as reported by the caregiver on a 5-point Likert scale (1 = "dislike a lot" and 5 = "like a lot")
At-home observation child willingness to eat the food12 hours (7AM - 7PM on at-home observation day)Voluntarily eaten, encouraged to consume, rejected
At-home observation caregiver willingness to use the recipe in the future12 hours (7AM - 7PM on at-home observation day)As reported on a 5-point Likert scale (1 = "not at all willing" and 5 = "extremely willing")

Countries

Niger

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026