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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,147
- 主要终点
- Recovery from MAM
研究概览
简要总结
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
-
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
-
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Super Cereal Plus (SC+) (Dietary Supplement)
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
干预措施: Super Cereal (SC), fortified oil, sugar (Dietary Supplement)
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
干预措施: Corn Soy Blend 14 (CSB14) and fortified oil (Dietary Supplement)
Plumpy'Sup
500 kcal/d, 92 g/d
Ready-to-Use Supplementary Food (RUSF)
干预措施: Plumpy Sup (Dietary Supplement)
结局指标
主要结局
Recovery from MAM
时间窗: 12 weeks
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
次要结局
- Change in Growth rates(12 weeks)
- Cost estimates for participation(12 weeks)
- Duration of treatment(12 weeks)
- Default reason(12 weeks)
- Change in recovery status after 12 weeks(6 months)