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| Name | Class |
|---|---|
| University of Ghana | OTHER |
| University of Cape Coast | OTHER |
| Ajinomoto USA, INC. | INDUSTRY |
| Ghana Health Services |
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Prevention of malnutrition in infants and children requires access and intake of nutritious food starting at birth with exclusive breastfeeding for the first 6 months of life, breastfeeding in combination with complementary foods from 6-24 months of age, access to clean drinking water and sanitation, access to preventive and curative health care (including prenatal).
In Ghana, the Demographic and Health Survey of 2014 reports rates of stunting, wasting and underweight in children aged 0-59 months are 28%, 14% and 9% respectively. Furthermore, height for age starts dropping from age 4-6 months with children aged 6-23 months being more likely to be stunted (40%) than those below 6 months (4%). Infant and young child feeding data show that for breast-fed children ranging from 6 months through 35 months of age, cereals are predominantly the first foods introduced in the diet (6-8 months of age). As the child grows older, consumption of fruits rich in Vitamin A, other fruits and vegetables and meat, fish, poultry and eggs are reported by the mothers. The Demographic and Health Survey (DHS) found that the proportion of breast fed children aged 6-23 months who received a recommended variety of foods the minimum number of times per day increases with child's age from 28% in children 6-8 months to 50% in children aged 18-23 months.
The study objective is to examine the effect of providing a macro- and micro-nutrient fortified complementary food supplement (KokoPlusTM) on growth and nutritional status of Ghanaian infants.
The current study is a cluster randomized single blind intervention design study with three study arms that aimed to examine the effect of providing a macro- and micro-nutrient fortified complementary food supplement (KokoPlus) for a period of 12 months (starting at 6 months of age) on growth and nutritional status of Ghanaian infants at 18 months of age. KokoPlus was formulated using linear programming methodology based on formative and market analysis research findings.
The subjects in this cluster-randomized trial are from communities in three districts of the Central region in Ghana with high rates of moderate and severe acute malnutrition. A total of 38 communities will be randomly assigned to one of three groups using block randomization and another 11 (randomly selected) will be followed cross sectionally as part of a fourth/non intervention group (growth monitoring).
The total sample size is 1204. Sample size calculations were based on two outcome measures: expected reduction in diarrheal morbidity and growth (improvements in height-for-age). Sample size estimates for detecting a 0.5 cm change in height in children provided a caloric and non caloric micronutrient supplement using a design effect of 2, power of 0.80, alpha of 0.05 and assuming an attrition rate of 15%, the required sample size per group was 301.
Mother-infant pairs will be recruited between infant age of 0 to 3 months to participate in monthly nutrition educations sessions and to encourage the women to continue exclusive breast feeding across all three groups. At 6 months of age, infants in each of the three groups were enrolled into the intervention study (upon receipt of informed consent). Data collection involves baseline, midline and endline measurements in the infants at 6, 12 and 18 months of age. In addition, participating mother-infant pairs will be visited weekly for delivery of the supplements and for morbidity monitoring and monthly for the measurement of anthropometry. Anthropometric measurements include: length (Infant/Child Shorr Height Board; Weigh and Measure, LLC ), weight (Seca 874 digital scale ), mid-upper arm circumference (MUAC) (Child MUAC Tape; Weigh and Measure, LLC), subscapular and triceps skinfolds (Holtain skinfold caliper ),head and chest circumference.
Data collection at baseline, midline and endline included one venous sample (3ml) from the infant, HemoCue (Model 301) measurement to assess severe anemia (7 \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KokoPlus and Nutrition Education | Active Comparator | Macro-micronutrient complementary food supplement and Nutrition Education |
|
| Micronutrient and Nutrition Education | Active Comparator | A micronutrient powder and Nutrition Education |
|
| Nutrition Education Only | Active Comparator | Nutrition Education |
|
| Growth Monitoring Only | No Intervention | Growth monitoring |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macro-micronutrient complementary food supplement | Dietary Supplement | This intervention provided a 15 g complementary food supplement called KokoPlus with nutrition education |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in monthly length for age Z-score (monthly LAZ) | Change in length for age Z-score from 6 months to 18 months of age. | Measured on a monthly basis until 18 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Hemoglobin | Change in serum hemoglobin from baseline to endline (6 months to 18 months) | Baseline (6 months), Midline (12 months of age), Endline (18 months of age) |
| Change in Serum retinol binding protein |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shibani Ghosh, PhD | Nevin Scrimshaw International Nutrition Foundation | Principal Investigator |
| Gloria Otoo, PhD | University of Ghana | Principal Investigator |
| Kwaku Tano-Debrah, PhD | University of Ghana | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19998866 | Background | de Pee S, Bloem MW. Current and potential role of specially formulated foods and food supplements for preventing malnutrition among 6- to 23-month-old children and for treating moderate malnutrition among 6- to 59-month-old children. Food Nutr Bull. 2009 Sep;30(3 Suppl):S434-63. doi: 10.1177/15648265090303S305. | |
| Background | Pan American Health Organization. Guiding Principles for Complementary Feeding of the Breast Fed Child p37, 2003 | ||
| Background | Ghana Statistical Service, Ghana Health Service, ICF Macro Ghana Demographic and Health Survey 2008, Accra, Ghana, p 512, 2009 | ||
| 34660654 |
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There is no plan to share individual participant data to other researchers
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| OTHER_GOV |
The study has three intervention arms and one cross sectional growth monitoring follow up group.
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Single blind cluster randomized trial - all participants in a community received the same treatment.
| A micronutrient powder | Dietary Supplement | This intervention provided a 1 g micronutrient powder with nutrition education |
|
| Nutrition education | Behavioral | This intervention provided nutrition education sessions |
|
Change in serum retinol binding protein from baseline to endline (6 months to 18 months)
| Baseline (6 months), Midline (12 months of age), Endline (18 months of age) |
| Change in serum transferrin receptors | Change from baseline to endline (6 months to 18 months) | Baseline (6 months), Midline (12 months of age), Endline (18 months of age) |
| Change in serum ferritin | Change from baseline to endline (6 months to 18 months) | Baseline (6 months), Midline (12 months of age), Endline (18 months of age) |
| Change in serum zinc | Change from baseline to endline (6 months to 18 months) | Baseline (6 months), Midline (12 months of age), Endline (18 months of age) |
| Change in Weight for age Z-score | This is the change in weight for age Z-score from 6 months to 18 months of age | Measured at baseline and then on a monthly basis for the duration of the intervention (12 months) |
| Change in Weight for height Z-score | This is the change in weight for length Z-score from 6 months to 18 months of age | Measured at baseline and then on a monthly basis for the duration of the intervention (12 months) |
| Prevalence of diarrhea | Prevalence of diarrhea over a 12 month period (duration of intervention) | Measured at baseline and then in a weekly surveillance for the duration of the intervention (12 months or 52 weeks) |
| Prevalence of upper respiratory infections | Prevalence of respiratory infections over a 12 month period (duration of the intervention) | Measured at baseline and then in a weekly surveillance for the duration of the intervention (12 months or 52 weeks) |
| Change in serum C-reactive protein | Change from baseline to endline (6 months to 18 months) | Baseline (6 months), Midline (12 months of age), Endline (18 months of age) |
| Change in serum alpha glycoprotein | Change from baseline to endline (6 months to 18 months) | Baseline (6 months), Midline (12 months of age), Endline (18 months of age) |
| Change in Head Circumference for age | This is the change in head circumference for age from 6 months to 18 months of | Measured at baseline and then on a monthly basis for the duration of the intervention (12 months) |
| Change in MUAC (Mid Upper Arm Circumference) | This is the change in MUAC for age from 6 months to 18 months of age | Measured at baseline and then on a monthly basis for the duration of the intervention (12 months) |
| Change in Plasma Amino Acid levels | This is the change in individual plasma amino acids from 6 months to 18 months | Baseline (6 months), Midline (12 months of age), Endline (18 months of age) |
| Derived |
| Furuta C, Sato W, Murakami H, Suri DJ, Otoo GE, Tano-Debrah K, Ghosh SA. Changes of Plasma Amino Acid Profiles in Infants With a Nutrient-Fortified Complementary Food Supplement: Evidence From a 12-Month Single-Blind Cluster-Randomized Controlled Trial. Front Nutr. 2021 Sep 30;8:606002. doi: 10.3389/fnut.2021.606002. eCollection 2021. |
| ID | Term |
|---|---|
| D006130 | Growth Disorders |
| D007228 | Infant Nutrition Disorders |
| D007732 | Kwashiorkor |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D000067011 | Severe Acute Malnutrition |
| D044342 | Malnutrition |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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