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

NCT02077907 | Terminated

• 2 other identifiers: AID-016-Sierra LeoneUSAID
• Study Type: interventional
• Target: 1,147
• Locations: 0 countries
• Sites: N/A

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. 1.Super Cereal Plus (SC+) at 800 kcal/d, 215 g/d (Control group)
2. 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. 3.Corn-soy Blend 14 (CSB14) and oil at 978 kcal/day - 150 g CSB14 and 45 g oil, per day
4. 4.Plumpy'Sup - 500 kcal/d, 92 g/d
5. 5.(Impact) To compare the effectiveness of four supplementary foods in the treatment of moderate acute malnutrition (MAM) in normal programmatic settings in Sierra Leone.
6. 6.(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
7. 7.(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
8. 8.Recovery from MAM
9. 9.Percent of children recovered from MAM (defined as achieving mid-upper arm circumference (MUAC) ≥ 12.5 cm by 12 weeks once)
10. 10.Percent default/non-response: children who do not recover after 12 weeks
11. 11.Percent relapse: children who become MAM again within 6 months of recovery
12. 12.Mean number of weeks to recovery

Conditions

Moderate Acute Malnutrition (MAM)

Outcome Measures

Primary 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

  12 weeks

Secondary Outcomes (5)

• Change in Growth rates

  12 weeks

• Duration of treatment

  12 weeks

• Cost estimates for participation

  12 weeks

• Default reason

  12 weeks

• Change in recovery status after 12 weeks

  6 months

Other Outcomes (2)

• Relative cost-effectiveness

  12 weeks

• Determinants of effectiveness

  12 weeks

Study Arms (4)

Super Cereal Plus (SC+)

ACTIVE COMPARATOR

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+)

Super Cereal (SC) and oil and sugar

EXPERIMENTAL

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

Corn Soy Blend 14 (CSB14) and fortified oil

EXPERIMENTAL

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

Plumpy'Sup

EXPERIMENTAL

500 kcal/d, 92 g/d Ready-to-Use Supplementary Food (RUSF)

Dietary Supplement: Plumpy Sup

Interventions

Super Cereal Plus (SC+) DIETARY_SUPPLEMENT

Super Cereal Plus (SC+)

Super Cereal (SC), fortified oil, sugar DIETARY_SUPPLEMENT

Super Cereal (SC) and oil and sugar

Plumpy Sup DIETARY_SUPPLEMENT

Plumpy'Sup

Corn Soy Blend 14 (CSB14) and fortified oil DIETARY_SUPPLEMENT

Corn Soy Blend 14 (CSB14) and fortified oil

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• 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)
• Beneficiary Mother/Caretaker whose child is diagnosed with MAM and enrolled to receive a ration from a feeding site
• Subject who is voluntarily willing to participate and indicates by signing (or marking with a thumbprint) the consent form.
• 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 \& 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
• All staff members from Project Peanut Butter and the PHU who are directly involved in the feeding program
• Staff members who joined too recently to have experience of the program change (new commodities)
• Village elder/headmen in study commune
• Village elder/headmen whose community is not involved in the feeding program

Sponsors & Collaborators

• Tufts University: lead
• Washington University School of Medicine: collaborator
• Project Peanut Butter: collaborator
• United Nations World Food Programme (WFP): collaborator
• United States Agency for International Development (USAID): collaborator

MeSH Terms

Interventions

Sugars

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Mark Manary, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Beatrice Rogers, PhD

  Tufts University, Friedman School of Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 4, 2014
• Study Start: January 1, 2014
• Primary Completion: July 1, 2014
• Last Updated: February 4, 2015

Record last verified: 2015-02