Clinical trial NCT02077907: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Moderate Acute Malnutrition (MAM)
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
name: Project Peanut Butter
name: United Nations World Food Programme (WFP)
name: United States Agency for International Development (USAID)
First posted: 2014-03-04
Enrollment: 1147
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Recovery from MAM
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Growth rates
timeFrame: 12 weeks
measure: Duration of treatment
timeFrame: 12 weeks
measure: Cost estimates for participation
timeFrame: 12 weeks
measure: Default reason
timeFrame: 12 weeks
measure: Change in recovery status after 12 weeks
timeFrame: 6 months
Other outcomes:
measure: Relative cost-effectiveness
timeFrame: 12 weeks
measure: Determinants of effectiveness
timeFrame: 12 weeks
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Mark Manary, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tufts University, Friedman School of Nutrition
name: Beatrice Rogers, PhD
role: PRINCIPAL_INVESTIGATOR
References: