Child Development, HIV Infections, Nutrition Poor
Conditions
Keywords
HIV-Exposed, Nutrient Status, KOKOPlus
Brief summary
The overall aim of the research is to conduct a randomised controlled trial of KOKOPlus in young HIV exposed children attending HIV clinics in Accra, Ghana to test the effectiveness of KOKOPlus over a period of 6 months to improve nutritional status and child development in HIV exposed children 6-18 months of age in Accra
Detailed description
The specific objectives are to accomplish the following 1. To test the effectiveness of KOKOPlus to improve the nutritional status of HIV exposed infants aged 6-18 months. 2. To measure and compare nutritional status in intervention and control arms by monitoring growth in terms of height and weight over the period of 6 months 3. To measure and compare micronutrient status of intervention and control arms by comparing baseline midline and endline measurements of hemoglobin levels. 4. To measure and compare morbidity rates of intervention and control arms. 5. To measure and compare rates of achievement of child development goals between intervention and control arms using a standardized tool, the Caregiver Reported Early Development Instrument (CREDI). 6. To understand and record experiences relating to the use of KOKOPlus of mothers/caregivers in the intervention arm through focus group discussion
Interventions
DIETARY_SUPPLEMENTKOKOPlus protein and micronutrient powder
KokoPlus, a complementary food supplement was formulated by using linear programming methodology to improve the protein quality as well as the micronutrient and macronutrient content of commonly consumed traditional complementary (baby) foods in Ghana . It contains soya powder, sugar and oil along with the essential amino acid lysine and a micronutrient mix. It complies with WHO's complementary feeding guidelines, FAO/WHO recommended micronutrient intake (RNI) and the WHO's guidelines for protein and essential amino acid intake for children in the age group of 6 to 24 months. A daily supply of KokoPlus achieves 30% of the total recommended energy, 60% of total protein and 40% of total fat requirements from complementary foods. It also meets 35-55% of minimum intake of essential amino acids and 50-150% RNI based on the total daily requirements.
Sponsors
International Food Policy Research Institute
Noguchi Memorial Institute for Medical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* Mother-infant dyads; HIV positive mothers and children between 6 and 12 months of age attending antiretroviral (ART) Clinics and child HIV Clinics.
Exclusion criteria
* Mothers who decline to participate in the study Children with severe acute malnutrition (mid-upper arm circumference \<115 mm or a weight-for-height/length \<-3 Z-scores of the WHO growth standards). Children on hospital admission Children with diagnosed or apparent congenital conditions such as encephalitis, cleft palate, hole in heart, which negatively affect the child's ability to eat and/or growth.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometry | 6 months | Length-for-age Z score, Weight-for-age Z score. Weight for length Z score |
| Haemoglobin | 6 months | (g/dl), anaemia |
| Child developmental Milestones achieved | 6 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | 6 months | Incidence of fever, malaise, loss of appetite |
Countries
Ghana
Contacts
Primary ContactGloria K Folson
Backup ContactGrace S Tokor
Outcome results
None listed