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Completed

NCT Number: NCT07506213

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)

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.

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Key information

Conditions

Moderate Acute Malnutrition (MAM) Body Weight Body Weight Changes Cachexia Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Age range

6 month–23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community

Madarounfa, Maradi Region, Niger

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Locally Available Food

Other

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.

Primary outcomes

  1. Observed test dose acceptability

    Time frame: During 30 minutes of test dose administration

    Consumption of ≥ 75% of the 50 g test dose within 30 minutes

  2. At-home observation acceptability

    Time frame: 12 hours

    Consumption of ≥ 75% of the caregiver-prepared recipe within the 12-hour observation period

Secondary outcomes

  1. Observed test dose consumption

    Time frame: During 30 minutes of test dose administration

    Consumption (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)

  2. Observed test dose recipe organoleptic ratings

    Time frame: Following completion of the 30-minute test dose period

    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").

  3. Observed test dose perceived child liking

    Time frame: Following completion of the 30-minute test dose period

    Perceived child liking as reported by the caregiver on a 5-point Likert scale (1 = "dislike a lot" and 5 = "like a lot")

  4. At-home observation recipe organoleptic ratings

    Time frame: 12 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")

  5. At-home observation child willingness to eat the food

    Time frame: 12 hours (7AM - 7PM on at-home observation day)

    Voluntarily eaten, encouraged to consume, rejected

  6. At-home observation caregiver willingness to use the recipe in the future

    Time frame: 12 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")

Sponsors and collaborators

Lead sponsor

Epicentre

Other

Collaborators

  • Harvard School of Public Health (HSPH)

Registry information

Official study title

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

Acronym: LAF

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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