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

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.

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

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

Aims

1. (Impact) To compare the effectiveness of four supplementary foods in the treatment of moderate acute malnutrition (MAM) in normal programmatic settings in Sierra Leone.
2. (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
3. (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

1. 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
2. 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.

Study Overview

• Status: Terminated
• Conditions: Moderate Acute Malnutrition (MAM)
• Intervention / Treatment: 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
• Enrollment (Actual): 1147
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Super Cereal Plus (SC+); 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.	Dietary supplement: Super Cereal Plus (SC+)
Experimental: Super Cereal (SC) and oil and sugar; 200 g SC and 20 g fortified oil and 15 g sugar, per day Fortified blended food (FBF) Fortified Oil with Vitamins A & D	Dietary supplement: Super Cereal (SC), fortified oil, sugar
Experimental: Corn Soy Blend 14 (CSB14) and fortified oil; 978 kcal/day - 150 g CSB14 and 45 g oil, per day Fortified blended food (FBF) Fortified Oil with Vitamins A & D	Dietary supplement: Corn Soy Blend 14 (CSB14) and fortified oil
Experimental: Plumpy'Sup; 500 kcal/d, 92 g/d Ready-to-Use Supplementary Food (RUSF)	Dietary supplement: Plumpy Sup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery from MAM	Percent of children recovered from MAM (defined as achieving mid-upper arm circumference (MUAC) ≥ 12.5 cm by 12 weeks once); Percent default/non-response: children who do not recover after 12 weeks; Percent relapse: children who become MAM again within 6 months of recovery	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Growth rates	Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Follow-up recovery will then be measured at 6 months. At each clinic visit growth will be measured.	12 weeks
Duration of treatment	Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Follow-up recovery will then be measured at 6 months. Time to achieve MUAC of 12.5 cm will be documented.	12 weeks
Cost estimates for participation	Average cost of treatment will be measured per participant, this includes intervention costs and any medical costs needed by participants. The study costs no money to participants.	12 weeks
Default reason	If a child defaults, then the reason will be an outcome measure. Reasons to default include loss to follow-up (the child will be attempted to be contacted 3 times prior to being considered lost), death, or he/she enters into the inpatient clinic.	12 weeks
Change in recovery status after 12 weeks	Any changes in recovery will be measured at 6 months at follow-up visits	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative cost-effectiveness	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	12 weeks
Determinants of effectiveness	To evaluate the determinants of effectiveness including: consumption adherence, preparation compliance, targeting/sharing of supplement, food components and preparation, adverse effects of foods, hygiene and health behaviors, SES, food security, perceived barriers	12 weeks

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: Washington University School of Medicine; United States Agency for International Development (USAID); United Nations World Food Programme (WFP); Project Peanut Butter
• Investigators: Principal Investigator: Beatrice Rogers, PhD, Tufts University, Friedman School of Nutrition

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: February 28, 2014
• First Submitted That Met QC Criteria: March 3, 2014
• First Posted (Estimate): March 4, 2014

Study Record Updates

• Last Update Posted (Estimate): February 4, 2015
• Last Update Submitted That Met QC Criteria: February 2, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: AID-016-Sierra Leone; USAID (Other Grant/Funding Number: GPO-A-00-05-00022-00;(W0118))