Comparison of Four Different Supplementary Foods in the Treatment of Moderate Acute Malnutrition (MAM) in Children in Sierra Leone: a Cluster-randomised, Controlled Clinical Effectiveness Trial

Tufts University

Status

Terminated

Conditions

Moderate Acute Malnutrition (MAM)

Treatments

Dietary Supplement: Plumpy Sup

Dietary Supplement: Super Cereal Plus (SC+)

Dietary Supplement: Super Cereal (SC), fortified oil, sugar

Dietary Supplement: Corn Soy Blend 14 (CSB14) and fortified oil

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT02077907

AID-016-Sierra Leone

USAID (Other Grant/Funding Number)

Details and patient eligibility

About

The objective of this study is to test and compare the effectiveness and cost-effectiveness of four supplementary foods for the treatment of moderate acute malnutrition (MAM) in normal programmatic settings in Sierra Leone. Study participants will receive one of four test foods varying in energy and nutrient density as well as amounts provided.

Super Cereal Plus (SC+) at 800 kcal/d, 215 g/d (Control group)
Super Cereal (SC) and oil and sugar at 998 kcal/d - 200 g SC and 20 g oil and 20 g sugar, per day
Corn-soy Blend 14 (CSB14) and oil at 978 kcal/day - 150 g CSB14 and 45 g oil, per day
Plumpy'Sup - 500 kcal/d, 92 g/d

This will be a prospective, randomised, controlled effectiveness trial.

Aims

(Impact) To compare the effectiveness of four supplementary foods in the treatment of moderate acute malnutrition (MAM) in normal programmatic settings in Sierra Leone.
(Cost) To estimate the relative cost-effectiveness (marginal cost per child recovered from MAM, relative to comparison group, SC+) of implementing the feeding program using each commodity, taking into consideration costs of procurement/production and distribution
(Process) To evaluate the determinants of effectiveness including: consumption adherence, preparation compliance, targeting/sharing of supplement, food components and preparation, adverse effects of foods, water contamination, hygiene and health behaviors, SES, food security, perceived barriers

Outcomes

Recovery from MAM
1. Percent of children recovered from MAM (defined as achieving mid-upper arm circumference (MUAC) ≥ 12.5 cm by 12 weeks once)
2. Percent default/non-response: children who do not recover after 12 weeks
3. Percent relapse: children who become MAM again within 6 months of recovery
Mean number of weeks to recovery

Hypothesis The children with MAM fed Super Cereal and oil and sugar, CSB14 and oil or Plumpy'Sup will have similar recovery outcomes to those children fed Super Cereal Plus.

Null: The children with MAM fed Super Cereal and oil and sugar, CSB14 and oil or Plumpy'Sup will have different recovery outcomes to those children fed Super Cereal Plus.

Enrollment

1,147 patients

Sex

All

Ages

6 to 59 months old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Beneficiary Children (Children 6 months to 59 months old)

Inclusion Criteria

Child diagnosed with MAM and enrolled to receive a ration from a feeding site (i.e. enrolled in the SFP) Exclusion Criteria
Children with bipedal oedema
Children receiving food rations from another organization (e.g. USAID or UNICEF)

Beneficiary Mothers/Caretakers (Mothers/Caretakers of Children 6 months to 59 months old)

Inclusion Criteria

Beneficiary Mother/Caretaker whose child is diagnosed with MAM and enrolled to receive a ration from a feeding site
Beneficiary Mother/Caretaker has no age restrictions for inclusion (Note: Mothers/caretakers will be asked to participate regardless of age and consented appropriately; it is possible some mothers may be minors)
Subject who is voluntarily willing to participate and indicates by signing (or marking with a thumbprint) the consent form.

Exclusion Criteria

• Beneficiary Mothers/Caretakers who participate in an interview, observation or FGD once for this study will not be eligible again for participation

Community Health Volunteers (CHV)/Health Development Committee Members (HDC) Inclusion Criteria

Community Health Volunteers & Health Development Committee Members serving within the catchment area for the PHUs
Community Health Volunteers that have been present during the study period
Subject who is voluntarily willing to participate and indicates by signing the consent form

PPB and Clinic Staff Members Inclusion Criteria

All staff members from Project Peanut Butter and the PHU who are directly involved in the feeding program
Subject who is voluntarily willing to participate and indicates by signing the consent form Exclusion Criteria
Staff members who joined too recently to have experience of the program change (new commodities)

Village Elders/Headmen Inclusion Criteria

Village elder/headmen in study commune
Subject who is voluntarily willing to participate and indicates by signing the consent form Exclusion Criteria
Village elder/headmen whose community is not involved in the feeding program

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,147 participants in 4 patient groups

Super Cereal Plus (SC+)

Active Comparator group

Description:

800 kcal/d, 215 g/d Current protocol for treating MAM is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. In Sierra Leone, their FBF standard is Super Cereal Plus.

Treatment:

Dietary Supplement: Super Cereal Plus (SC+)

Super Cereal (SC) and oil and sugar

Experimental group

Description:

200 g SC and 20 g fortified oil and 15 g sugar, per day Fortified blended food (FBF) Fortified Oil with Vitamins A \& D

Treatment:

Dietary Supplement: Super Cereal (SC), fortified oil, sugar

Corn Soy Blend 14 (CSB14) and fortified oil

Experimental group

Description:

978 kcal/day - 150 g CSB14 and 45 g oil, per day Fortified blended food (FBF) Fortified Oil with Vitamins A \& D