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) (LAF)

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

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.

Study Overview

• Status: Completed
• Conditions: Moderate Acute Malnutrition (MAM)
• Intervention / Treatment: Other: Locally Available Food

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Niger
  • Maradi Region
    • Madarounfa, Maradi Region, Niger
      • Community

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recipe #1; 45g wheat, bran; 10g cowpea, uncooked; 39g sesame butter, tahini; 25g fish, dried fresh water; 3g leaf, drumstick, dried; 9g baobab, pulp, flour; 2g MNP, WFP 2022	Other: Locally 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.
Experimental: Recipe #2; 44g wheat, bran; 16g cowpea, uncooked; 38g fish, dried fresh water; 3g leaf, drumstick, dried; 9g baobab, pulp, flour; 20g oil, vegetable; 2g MNP, WFP 2022	Other: Locally 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.
Experimental: Recipe #12; 34g sesame butter, tahini; 16g okra, dried; 14g bean, african locust, fermented, dried; 46g fish, dried fresh water; 19g leaf, baobab, dried; 7g baobab, pulp, flour; 2g MNP, WFP 2022	Other: Locally 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.
Experimental: Recipe #20; 24g cowpea, uncooked; 4g groundnut, flour with fat; 90g fish, sardines in oil, canned; 24g leaf, drumstick, dried; 8g baobab, pulp, flour; 10g oil, vegetable; 20g beef, dried, boneless; 2g MNP, WFP 2022	Other: Locally 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.
Experimental: Recipe #22; 32g millet, finger; 7g cowpea, uncooked; 11g sesame butter, tahini; 10g groundnut paste; 20g groundnut, flour with fat; 8g fish, dried fresh water; 4g leaf, drumstick, dried; 16g leaf, baobab, dried; 8g baobab, pulp, flour; 4g oil, vegetable; 2g MNP, WFP 2022	Other: Locally 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.
Experimental: Recipe #24; 166g okra, dried; 8g fish, dried fresh water; 14g Leaf, drumstick, dried; 23g oil, groundnut; 2g MNP, WFP 2022	Other: Locally 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
At-home observation acceptability	Consumption of ≥ 75% of the caregiver-prepared recipe within the 12-hour observation period	12 hours
Observed test dose acceptability	Consumption of ≥ 75% of the 50 g test dose within 30 minutes	During 30 minutes of test dose administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observed test dose consumption	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)	During 30 minutes of test dose administration
Observed test dose recipe organoleptic ratings	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").	Following completion of the 30-minute test dose period
Observed test dose perceived child liking	Perceived child liking as reported by the caregiver on a 5-point Likert scale (1 = "dislike a lot" and 5 = "like a lot")	Following completion of the 30-minute test dose period
At-home observation recipe organoleptic ratings	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")	12 hours (7AM - 7PM on at-home observation day)
At-home observation child willingness to eat the food	Voluntarily eaten, encouraged to consume, rejected	12 hours (7AM - 7PM on at-home observation day)
At-home observation caregiver willingness to use the recipe in the future	As reported on a 5-point Likert scale (1 = "not at all willing" and 5 = "extremely willing")	12 hours (7AM - 7PM on at-home observation day)

Collaborators and Investigators

• Sponsor: Epicentre
• Collaborators: Harvard School of Public Health (HSPH)

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2022
• Primary Completion (Actual): November 11, 2022
• Study Completion (Actual): November 11, 2022

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: wasting; Niger; acceptability; Moderate acute malnutrition; MAM; lipid-based nutrient supplements; LAF; locally available foods; supplementary food; specially formulated foods; linear programming
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Thinness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cachexia
• Other Study ID Numbers: LAF MAM Niger; INV-023315 (Other Grant/Funding Number: Gates Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No