Child Development, Dietary Habits, Food, Fortified
Conditions
Brief summary
This study aims to evaluate the acceptability of bouillon cubes fortified with six micronutrients for which deficiency is common among women and children in Ghana and to assess the feasibility and reliability of data collection methods to be used in a planned, more detailed study to evaluate the effect of multiple micronutrient (MN)-fortified bouillon cube on biomarkers of nutrient status, health and development of women and children.
Detailed description
Background: Micronutrient (MN) deficiencies are severe and widespread in West Africa, particularly among young children and women of reproductive age. Bouillon is a promising food fortification vehicle because the product is centrally processed on large scale, consumed by many households in West African countries (even rural, poor households), and consumed by most members of the household in relatively constant amounts. However, several important research questions remain regarding whether the use of fortified bouillon would be feasible, acceptable and effective for preventing micronutrient deficiencies in communities where such deficiencies are common. Objectives: This study aims (1) to evaluate the acceptability of bouillon cubes formulated with 6 micronutrients for which deficiency is common among women and children in Ghana and (2) to access the feasibility and reliability of data collection methods to be used in a later study of the effects of fortified bouillon, compared to control, on micronutrient status, health, and development. Methods: This acceptability study will be conducted in the Kumbungu and Tolon districts in the Northern Region, where a recent survey showed that micronutrient deficiencies were common. The investigators will recruit non-pregnant adult women (15+ years old) (n = 84) who are responsible for household meal preparation, to participate in sensory testing of an uncooked fortified bouillon as well as a cooked food containing the fortified bouillon. Subsequently, participants will receive a 14-day supply of fortified bouillon cubes to use at home, after which they will be asked their opinions about the bouillon. Three fortified bouillon formulations will be tested: 1) upper-level bouillon, fortified with iron, zinc, iodine, vitamin A, folic acid, and vitamin B-12, 2) lower-level bouillon, containing the same 6 micronutrients but with lower concentrations of some micronutrients, and 3) a control bouillon, fortified with iodine only. Participants will be in the study for approximately 18 days (study day 0 to study day 17). In addition, children 2-6 years of age in households of enrolled women will be eligible to participate in a pilot study to evaluate the feasibility and test-retest reliability of several methods to assess child development. For these children, child development will be assessed at two home visits during the 14-day period of fortified bouillon use at home.
Interventions
DIETARY_SUPPLEMENTUpper-level multiple micronutrient-fortified bouillon cube
80 µg/g Folic acid 1.2 µg/g Vitamin B12 3 mg/g Zinc (ZnO) 4 mg/g Iron (FePP/citric acid/trisodium citrate) 200 µg/g Vitamin A (retinyl palmitate) 30 µg/g Iodine (KIO3)
DIETARY_SUPPLEMENTLower-level multiple micronutrient-fortified bouillon cube
28.8 µg/g Folic acid 0.288 µg/g Vitamin B12 1.68 mg/g Zinc (ZnO) 1.3 mg/g Iron (FePP/citric acid/trisodium citrate) 96 µg/g Vitamin A (retinyl palmitate) 30 µg/g Iodine (KIO3)
DIETARY_SUPPLEMENTIodine-fortified bouillon cube
30 µg/g Iodine (KIO3)
Sponsors
University of Ghana
Helen Keller International
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
All participants will participate in sensory testing (acceptability, preference and discrimination testing) of three uncooked fortified bouillon cubes (upper-level, lower-level and control), as well as cooked foods containing the three different bouillon cubes. Participants will then be randomized to one of three groups (upper-level, lower-level or control), and receive a 14 day supply of study-provided bouillon cubes to use at home.
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Acceptability study: * self-reported non-pregnant adult women (15+ years) * responsible for meal preparation in the household * signed the informed consent form Child development assessment pilot sub-study: * 2-6 years of age (24-71 months) * residing in the same household as an enrolled woman * child's primary caregiver signs the informed consent form
Exclusion criteria
* severe illness warranting immediate hospital referral * COVID-19 exposure, positive test, or current symptoms (including fever, cough, shortness of breath, loss of smell, vomiting, or diarrhea \[\> 3 liquid or semi-liquid stools in 24h\]) of illness * chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially interfering with nutritional status or affecting child development (children only) * presence of ailments (such as toothache, or mouth pain) that may impact a participant's ability to complete study activities (women only) * unable to provide informed consent due to impaired decision making abilities * current participation in a clinical trial * reported shrimp, wheat, milk, soy, eggs, celery, fish, or mollusc allergy, or a previous adverse reaction to bouillon by anyone in the household * refusal to use provided bouillon cubes to prepare household meals while enrolled in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Responsive care and learning opportunities in the home environment: Home Observation for the Measurement of the Environment (HOME) Inventory score | From study day 3 to study day 17 (2 weeks) | * measured twice during study to assess test-retest reliability * intraclass correlation coefficient of HOME inventory |
| Consumption of a soup dish cooked with multiple micronutrient-fortified bouillon cubes | Study day 1 or 2 | * centre-based, soup dish randomly assigned to be consumed on study day 1 or 2 * acceptability of multiple micronutrient-fortified bouillon cubes based on percent of test portions consumed (of commonly consumed dishes cooked with multiple micronutrient-fortified bouillon cubes) |
| Consumption of a rice-based dish cooked with multiple micronutrient-fortified bouillon cubes | Study day 1 or 2 | * centre-based, rice-based dish randomly assigned to be consumed on study day 1 or 2 * acceptability of multiple micronutrient-fortified bouillon cubes based on percent of test portions consumed (of commonly consumed dishes cooked with multiple micronutrient-fortified bouillon cubes) |
| Sensory perceptions of dishes cooked with multiple micronutrient-fortified bouillon cubes | Study day 17 | * in-home acceptability trial (2 weeks), study-provided bouillon cubes used in all household cooking * ratings of sensory attributes (appearance, smell, taste and overall) on 5 point hedonic scales * ratings of presence of specific organoleptic characteristics (just-about-right and check-all-that-apply) |
| Quantity of study-provided bouillon cubes used | Study day 17 | * in-home acceptability trial (2 weeks) * number of study-provided bouillon cubes used in household over two week trial period |
| Study-provided bouillon cube use as a proportion of total bouillon use | Study day 17 | * in-home acceptability trial (2 weeks) * number of study-provided bouillon cubes used in household over two week trial period, as a proportion of all household bouillon use (study-provided plus non-study provided) |
| Change in child development scores on the Malawi Developmental Assessment Tool (MDAT) | From study day 3 to study day 17 (2 weeks) | * gross motor, fine motor, language, and personal-social scores * measured twice during study to assess test-retest reliability * intraclass correlation coefficient of MDAT |
| Sensory perceptions of multiple micronutrient-fortified bouillon cubes (uncooked) | Study day 1 | * centre-based * ratings of sensory attributes (appearance, feel, smell, taste and overall) on 5 point hedonic scales * ratings of presence of specific organoleptic characteristics (just-about-right and check-all-that-apply) |
| Sensory perceptions of a soup dish cooked with multiple micronutrient-fortified bouillon cubes | Study day 1 or 2 | * centre-based, soup dish randomly assigned to be consumed on study day 1 or 2 * ratings of sensory attributes (appearance, smell, taste and overall) on 5 point hedonic scales * ratings of presence of specific organoleptic characteristics (just-about-right and check-all-that-apply) |
| Sensory perceptions of a rice-based dish cooked with multiple micronutrient-fortified bouillon cubes | Study day 1 or 2 | * centre-based, rice-based dish randomly assigned to be consumed on study day 1 or 2 * ratings of sensory attributes (appearance, smell, taste and overall) on 5 point hedonic scales * ratings of presence of specific organoleptic characteristics (just-about-right and check-all-that-apply) |
| Ability to discriminate among different multiple micronutrient-fortified bouillon cubes (uncooked) | Study day 1 | * centre-based * triangle test (ability to identify the odd sample correctly) |
| Preference test of multiple micronutrient-fortified bouillon cubes (uncooked) | Study day 1 | * centre-based * preference for the multiple micronutrient-fortified bouillon cubes compared to the iodine-fortified control cube (appearance, feel, smell and taste) |
| Preference test of a soup dish cooked multiple micronutrient-fortified bouillon cubes | Study day 1 or 2 | * centre-based, soup dish randomly assigned to be consumed on study day 1 or 2 * preference for the multiple micronutrient-fortified bouillon cubes compared to the iodine-fortified control cube (appearance, feel, smell and taste) when prepared in commonly consumed dishes |
| Preference test of a rice-based dish cooked multiple micronutrient-fortified bouillon cubes | Study day 1 or 2 | * centre-based, rice-based dish randomly assigned to be consumed on study day 1 or 2 * preference for the multiple micronutrient-fortified bouillon cubes compared to the iodine-fortified control cube (appearance, feel, smell and taste) when prepared in commonly consumed dishes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Household-level consumption of bouillon | Study day 0 | * patterns of bouillon use prior to the study (pre-intervention) * assessed at the initial study visit |
| Change in willingness to pay for multiple micronutrient-fortified bouillon cubes | Study day 1 and 17 | * assessed pre- and post-intervention * hypothetical willingness-to-pay for multiple micronutrient-fortified bouillon cubes before and after exposure to the study-provided bouillon cubes |
| Themes from focus group discussions | Study day 2 and 17 | * acceptability of the multiple micronutrient-fortified bouillon cubes, experiences of using the multiple micronutrient-fortified bouillon cubes in daily cooking and willingness to use multiple micronutrient-fortified bouillon cubes in the future * pre- and post-intervention * conducted using a structured focus group discussion guide |
| Perceived health effects of using study-provided multiple micronutrient-fortified bouillon cubes | Study day 17 | * post-intervention * questionnaire to assess perceived positive and negative health effects |
| Sensory perceptions of dishes cooked with multiple micronutrient-fortified bouillon cubes | Study day 9 | * mid-point of in-home acceptability trial (1 week), study-provided bouillon cubes used in all household cooking * ratings of sensory attributes (appearance, smell, taste and overall) on 5 point hedonic scales * ratings of presence of specific organoleptic characteristics (just-about-right and check-all-that-apply) |
| Household-level consumption of salt | Study day 0 | * patterns of salt use prior to the study (pre-intervention) * assessed at the initial study visit |
Countries
Ghana
Outcome results
None listed