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)

NCT07506213 | Completed

• 2 other identifiers: LAF MAM NigerINV-023315
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Observed test dose acceptability

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

  30 minutes

• At-home observation acceptability

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

  12 hours

Secondary Outcomes (6)

• Observed test dose consumption

  30 minutes.

• Observed test dose recipe organoleptic ratings

  30 minutes.

• Observed test dose perceived child liking

  30 minutes

• At-home observation recipe organoleptic ratings

  12 hours

• At-home observation child willingness to eat the food

  12 hours

Study Arms (6)

Recipe #1

EXPERIMENTAL

* 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

Recipe #2

EXPERIMENTAL

* 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

Recipe #12

EXPERIMENTAL

* 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

Recipe #20

EXPERIMENTAL

* 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

Recipe #22

EXPERIMENTAL

* 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

Recipe #24

EXPERIMENTAL

* 166g okra, dried * 8g fish, dried fresh water * 14g Leaf, drumstick, dried * 23g oil, groundnut * 2g MNP, WFP 2022

Other: Locally Available Food

Interventions

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.

Recipe #1; Recipe #12; Recipe #2; Recipe #20; Recipe #22; Recipe #24

Eligibility Criteria

• Age: 6 Months - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Epicentre: lead
• Harvard School of Public Health (HSPH): collaborator

Study Sites (1)

Community

Madarounfa, Maradi Region, Niger

Location

MeSH Terms

Conditions

Cachexia

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants, caregivers, and study staff were not blinded to recipe identity due to the nature of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: August 19, 2022
• Primary Completion: November 11, 2022
• Study Completion: November 11, 2022
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

NI (1)