Gloria Folson and Futoshi Yamauchi Side Event: How Japan’s know-how can help address food and nutrition challenges in the developing world Tokyo Nutrition for Growth (N4G) Summit 2021 NOV 30, 2021

1. Supplementation Trial of KOKO Plus Among HIV
Exposed Children in Accra
SOURCE OF FUNDING: GOVERNMENT OF JAPAN THROUGH IFPRI
COLLABORATING INSTITUTIONS:
IFPRI
UG-NMIMR
KORLE-BU TEACHING HOSPITAL
PIs: Dr. Gloria Folson, Dept of Nutrition, NMIMR, UG
Dr Futoshi Yamauchi (Project Leader), Markets, Trade & Institutions, IFPRI

2. Background
Over a million babies are born to HIV mothers annually worldwide.
In 2019, a total of 20,068 people were newly infected with HIV and children
between 0-14 years constituted about 15%.
HIV exposed children, regardless of their HIV status are at greater risk of
malnutrition and consequently to an extent, slower motor and cognitive
development than their HIV unexposed counterparts.
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342, 307 people are living with
HIV in Ghana
Males – 122,321 (36%) Females – 219,986 (64%)

3. Aims and objectives of the study
Aim:
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.
Objectives: To measure and compare the ff between intervention and
control arms
1) Nutritional status
2) Micronutrient status
3) Morbidity rates
4) Achievement of child development goals using a standardized tool,
the Caregiver Reported Early Development Instrument (CREDI).
5) To understand and record experiences relating to the use of
KOKOPlus of mothers/caregivers in the intervention arm through
focus group discussion 3

4. 4
Inclusion
• HIV positive mothers and their children between 6 and 18
months of age attending antiretroviral (ART) Clinics and child
HIV Clinics.
Exclusion
• Mothers who decline to participate in the study
• Children with (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.
INCLUSION AND EXCLUSION CRITERIA
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5. Ingredients g %
Soyabean 7.313 48.8
Palm oil 0.976 6.5
Sugar 5.600 37.3
Lysine 0.112 0.75
Micronutrient premix 1.00 6.7
Total 15.00 100
FORMULATION OF COMPLEMENTARY FOOD SUPPLEMENT KOKO PLUS
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• KOKOPlus has been found to be microbially safe and its shelf life estimated to be more than 12 months.
• Ghosh et al (2019) found a potential positive dose-response effect of KOKOPlus on length-for age,
weight-for-age and weight-for-length z scores
• KOKOPlus is produced by the Ghana Nutrition Improvement Project (GNIP), supported by the
Ajinimoto Foundation.

6. Total sample size : 638
Study sites include 19 health
facilities in Greater Accra
Randomization
of participants
Study population: HIV +ve
mothers and their children (6 –
18 months)
METHODOLOGY
Calculated with reference from
(Prendergast et al., 2019)
Recruitment of
participants
Study Sites: Korle-Bu teaching hospital, Greater Accra
Regional Hospital, Princess Marie Louise Hospital,
Ledzokuku-Krowor Municipal Assembly (LEKMA)
Hospital, Shai-Osudoku District Hospital, Tema General
Hospital, Tema Polyclinic, Ashaiman Polyclinic,
Manhean Polyclinic, Pentecost Hospital-Madina,
Madina Polyclinic Kekele, Weija Gbawe Municipal
Hospital, Ga West Municipal Hospital-Amasaman, Ga
North Municipal Hospital-Ofankor, Kaneshie Polyclinic,
Mamprobi Polyclinic, Maamobi General Hospital Legon
Hospital and Achimota Hospital
• Recruitment of participants is done in the health
facilities
• During randomization, consented mothers are asked
to pick lots to join a particular study arm
(intervention or control)
• Participants are given study participation cards with
their study identifier written on them. The card is
also used to record next appointment date for follow
up as reminders for mothers
• Each mother is assigned to an enumerator who
follows her up on phone.
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7. Measurements Time points Measures/Tool Indicators
Socio-demographics
of household and
caregiver
0; Baseline Questionnaire Education, occupation, income
dwelling, amenities, marital status
religion, duration of HIV infection
Mothers’
anthropometry
0, Baseline Weighing scale, height
meter
BMI (height & weight)
Body composition parameters (body
fat……)
Child history 0; Baseline Weighing card/health
records
Date of birth, sex, birth weight
anthropometric measurements 0-6
months
Hb 0,3,6 months Hemocue measurement Hb (g/dl), red cell parameters, anaemia
Dietary assessment 0,3,6 months Nutrient intake,
Dietary diversity
Average daily intake, Dietary adequacy
Dietary diversity
Anthropometry 0,1,2,3,4,5,6
months
Weight, recumbent
length
WAZ, LAZ, WLZ
Development 0,1,2,3,4,5,6
months
Questionnaire Number of milestones achieved fo
specific age ranges (6—12 months and
12-17 months)
KokoPlus
consumption
Fortnightly Number of sachets
consumed
Number of sachets consumed
Morbidity Fortnightly Questionnaire Incidence of fever, malaise, loss o
appetite
HIV status 6 months; endline Hospital records DNA-PCR test result
DATA COLLECTION SCHEDULE
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8. • Participants in the intervention arm receive KOKOPlus and nutrition education.
• Participants in the control arm receive nutrition education, no KOKOPlus.
• Both arms receive no placebo during the study period.
• Nutrition education is done monthly on individual basis with reference to the child’s age.
• All questionnaires are administered electronically using Computer Assisted Personal
Interview (CAPI) technology.
WORKFLOW AT A CLINIC SESSION
NEW PARTICIPANTS
Verification and consent
seeking
Randomization into control
and intervention arms
OLD PARTICIPANTS
Registry checks
participants’ due timepoint
Baseline data collection
Data collection
Collection of KOKOPlus,
incentive and transportation
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9. ATTENDANCE AND CONSUMPTION CARDS
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10. Intervention Control Total
Total recruited 295 284 579
Reasons for dropping out
Husband refused 2 2
Child’s reaction to supplement 5 5
Can’t find time to visit clinic 4 4
Child has a disability 1 1
Sick child (preterm) 1 1
Wrongly enrolled (excluded) 17 23 40
Total number dropped out/excluded 28 25 53
Current arm status 267 259 526
Table 1: Dropouts/excluded participants and reasons for exclusion/dropping out
• 53 mother-child dyads have either been excluded or dropped out of the study.
• The most common reason is that children reacted to the supplements.
• The reactions mentioned by mothers include diarrhea and coughing.
• The most common reason for exclusion is either mother is HIV negative or child has a disability
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11. RESULTS (INTERIM BASELINE DATA)
Table 2 Enrolment at various facilities
Facility Number of children
Male Female Total
Korle-Bu Teaching Hospital 15 (41.67) 21 (58.33) 36
Greater Accra Regional Hospital 21 (50.00) 21 (50.00) 42
Princess Marie Louise Hospital 11 (68.75) 5 (31.25) 16
Ashiaman Polyclinic 57 (48.31) 61 (51.69) 118
LEKMA Hospital 20 (47.62) 22 (52.38) 42
Tema General Hospital 2 (40.0) 3 (60.0) 5
Waija Gbawe 11 (37.93) 18 (62.07) 29
Amasaman 27 (56.25) 21 (43.75) 48
Dodowa 17 (44.74) 21 (55.26) 38
Madina Kekele 14 (53.85) 12 (46.15) 26
Madina Pentecost 13 (68.42) 6 (31.58) 19
Maamobi 5 (62.50) 3 (37.50) 8
Tema Polyclinic 7 (50.0) 7 (50.0) 14
Achimota 3 (42.86) 4 (57.14) 7
Kaneshie Polyclinic 17 (60.71) 11 (39.29) 28
Mamprobi 9 (50.0) 9 (50.0) 18
Ofankor 5 (35.71) 9 (64.29) 14
Tema Manhean 9 (90.0) 1 (10.0) 10
Legon Hospital 4 (50.0) 4 (50.0) 8
Total 267 (50.76) 259 (49.24) 526
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12. Table 3: Characteristics of mother disaggregated by study arm
Intervention (n=250) Control n(255) Total
Age: mean ± Std 32.6 ± 5.5 32.5 ± 5.4 p=0.929
15-30yrs 94 (35.47) 89 (34.10) 183 (34.79)
31-40yrs 152 (57.36) 154 (59.00) 306 (58.17)
Above 40yrs 19 (7.17) 18 (6.90) 37 (7.03)
Ethnicity (%) p=0.963
Akan 92 (34.72) 86 (32.95) 178 (33.84)
Ga/Dangme 58 (21.89) 56 (21.46) 114 (21.67)
Ewe 67 (25.28) 70 (26.82) 137 (26.05)
Other 48 (18.11) 49 (18.77) 97 (18.44)
Religion (%) p=0.197
Christian 237 (89.43) 227 (86.97) 464 (88.21)
Islam 26 (9.81) 34 (13.03) 60 (11.41)
Other 2 (0.75) - 2 (0.38)
Educational level p=0.394
Primary 40 (16.00) 32 (13.56) 72 (14.81)
JHS 115 (46.00) 116 (49.15) 231 (47.53)
SHS 63 (25.20) 69 (29.24) 132 (27.16)
Voc/Tech 19 (7.60) 11 (4.66) 30 (6.17)
University/higher 13 (5.20) 8 (3.39) 21 (4.32)
BMI categories (%) p=0.783
Underweight 6 (2.33) 4 (1.57) 10 (1.95)
Healthy 103 (39.92) 104 (40.78) 207 (40.35)
Overweight 75 (29.07) 81 (31.76) 156 (30.41)
Obese 74 (28.68) 66 (25.88) 140 (27.29)
Intervention Control Total
Age p=0.917
6-12 months 153 (57.74) 153 (58.62) 306 (58.17)
13-15 months 45 (16.98) 46 (17.62) 91 (17.30)
16-18 months 67 (25.28) 62 (23.75) 129 (24.52)
Sex p=0.046
Male 132 (49.81) 135 (51.72) 267 (50.76)
Female 133 (50.19) 126 (48.28) 259 (49.24)
Table 4: Characteristics of children disaggregated by study arm
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• Age distribution was similar
between groups
• The are more males than females
enrolled in the study.

13. Intervention Control Total
WAZ: mean ± std -0.716 ± 1.07 -0.729 ± 1.27 p=0.314
Severely underweight 1 (0.38) 1 (0.38) 2 (0.38)
Underweight 25 (9.43) 35 (13.41) 60 (11.41)
Normal 237 (89.43) 220 (84.29) 457 (86.88)
Overweight 2 (0.75) 5 (1.92) 7 (1.33)
HAZ : mean ± std 0.044 ± 3.0 0.057 ± 3.0 p=0.346
Severely stunted 5 (1.89) 8 (3.07) 13 (2.47)
Stunted 20 (7.55) 27 (10.34) 47 (8.94)
Normal 240 (90.57) 226 (86.59) 466 (88.59)
WHZ: mean ± std -0.840 ± 1.87 -0.874 ± 2.01 0.836
Severely wasted 16 (6.04) 21 (8.05) 37 (7.03)
Wasted 21 (7.92) 19 (7.28) 40 (7.60)
Normal 222 (83.77) 215 (82.38) 437 (83.08)
Overweight 6 (2.26) 6 (2.30) 12 (2.28)
HB: mean ± std 10.071 ± 1.56 10.029 ± 1.58 p=0.786
Non aneamic 62 (23.75) 89 (35.32) 151 (29.43)
Mild 71 (27.20) 70 (27.78) 141 (27.49)
Moderate 123 (47.13) 86 (34.13) 209 (40.74)
Severe 5 (1.92) 7 (2.78) 12 (2.34)
• The mean weight for age z-score (WAZ) for the intervention arm was -0.716 ± 1.07 and that for the control arm was -0.729 ±
1.27 (p=0.314). (<5s, Accra= -0.6, MICS, 2017/18)
• The mean height for age z scores (HAZ) for intervention and control arms were 0.044 ± 3.0 and 0.057 ± 3.0 respectively
(p=0.346). (<5s, Accra = -0.6, MICS, 2017/18)
• The mean weight for height z scores (WHZ) for intervention and control arms were -0.840 ± 1.87 and -0.874 ± 2.01
respectively. (<5s, Accra = -0.4 MICS, 2017/18)
• The two study arms did not differ with respect to nutritional indicies WAZ, HAZ and WHZ.
• 1 child was found to be severely underweight and have been duly excluded from the study
Table 5: Nutritional status of children disaggregated by study arm

14. Male Female Total
WAZ: mean ± std -0.967 ± 1.37 -0.755 ± 1.15 p=0.025
Severely underweight 1 (0.37) 1 (0.39) 2 (0.38)
Underweight 39 (14.61) 21 (8.1) 60 (11.41)
Normal 221 (82.77) 236 (91.12) 457 (86.88)
Overweight 6 (2.25) 1 (0.39) 7 (1.33)
HAZ : mean ± std -0.105 ± 3.26 0.156 ± 3.04 p=0.400
Severely stunted 9 (3.37) 4 (1.54) 13 (2.47)
Stunted 24 (8.99) 23 (8.88) 47 (8.94)
Normal 234 (8.64) 232 (89.58) 466 (88.59)
WHZ : mean ± std -0.874 ± 2.09 -0.839 ± 1.78 p=0.009
Severely wasted 21 (7.87) 16 (6.18) 37 (7.03)
Wasted 27 (10.11) 13 (5.02) 40 (7.60)
Normal 209 (78.28) 228 (88.03) 437 (83.08)
Overweight 10 (3.75) 2 (0.77) 12 (2.28)
HB: mean ± std 9.78 ± 1.7 10.11 ± 1.53 p=0.009
Non anaemic 62 (23.75) 89 (35.32) 151 (29.43)
Mild 71 (27.20) 70 (27.78) 141 (27.49)
Moderate 123 (47.13) 86 (34.13) 209 (40.74)
Severe 5 (1.92) 7 (2.78) 12 (2.34)
Table 6: Nutritional status of children disaggregated by sex
• Males had mean WAZ of -0.967 ± 1.37 and females had mean WAZ of -0.755 ± 1.15 (p=0.025).
• Also, males had mean WHZ of -0.874 ± 2.09 and females had mean WHZ of -0.839 ± 1.78 (p=0.009).
• Males and females did not differ with respect to HAZ
• Mean Hb for males was 9.78g/dL ± 1.7 and that for females was 10.11g/dL ± 1.53 (p=0.009).
• Baseline data however shows that male and female participants differed significantly with respect to WAZ. 15

15. 6-12 months 13-15 months 16-18 months Total
WAZ: p=0.383
Severely underweight 0 (0) 1 (1.10) 1 (0.78) 2 (0.38)
Underweight 35 (11.44) 11 (12.09) 14 (10.85) 60 (11.41)
Normal 268 (87.58) 76 (83.52) 113 (87.6) 457 (86.88)
Overweight 3 (0.98) 3 (3.30) 1 (0.78) 7 (1.33)
HAZ : p=0.365
Severely stunted 7 (2.29) 2 (2.20) 4 (3.10) 13 (2.47)
Stunted 24 (7.84) 6 (6.59) 17 (13.18) 47 (8.94)
Normal 275 (89.87) 83 (91.21) 108 (83.72) 466 (88.59)
WHZ: p=0.074
Severely wasted 24 (7.84) 7 (7.69) 6 (4.65) 37 (7.03)
Wasted 23 (7.52) 5 (5.49) 12 (9.30) 40 (7.60)
Normal 255 (83.33) 73 (80.22) 109 (84.50) 437 (83.08)
Overweight 4 (1.31) 6 (6.59) 2 (1.55) 12 (2.28)
HB: p=0.260
Non anemic 83 (27.67) 21 (24.14) 47(37.30) 151 (29.43)
Mild 87 (29.0) 22 (25.29) 32 (25.40) 141 (27.49)
Moderate 122 (40.67) 41 (47.13) 46 (36.51) 209 (40.74)
Severe 8 (2.67) 3 (3.45) 1 (0.79) 12 (2.34)
Table 7: Nutritional status of children disaggregated by age grouping
• Participants did not differ significantly in any of the nutritional outcomes across age groupings
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16. CONCLUSION
• The baseline results show successful randomisation of participants between
intervention and control arms with respect to sociodemographic variables and
measures of nutritional status.
THANK YOU
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