A Study to Evaluate the Acceptability of a Multiple Micronutrient-fortified Bouillon Cube in Women and Their Households in Two Districts in the Northern Region of Ghana
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Preference test of multiple micronutrient-fortified bouillon cubes (uncooked)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Preference test of multiple micronutrient-fortified bouillon cubes (uncooked)
时间窗: 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
时间窗: 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
Consumption of a soup dish cooked with multiple micronutrient-fortified bouillon cubes
时间窗: 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
时间窗: 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)
Quantity of study-provided bouillon cubes used
时间窗: Study day 17
* in-home acceptability trial (2 weeks) * number of study-provided bouillon cubes used in household over two week trial period
Sensory perceptions of multiple micronutrient-fortified bouillon cubes (uncooked)
时间窗: 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
时间窗: 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
时间窗: 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")
Preference test of a rice-based dish cooked multiple micronutrient-fortified bouillon cubes
时间窗: 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
Sensory perceptions of dishes cooked with multiple micronutrient-fortified bouillon cubes
时间窗: 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")
Study-provided bouillon cube use as a proportion of total bouillon use
时间窗: 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)
Ability to discriminate among different multiple micronutrient-fortified bouillon cubes (uncooked)
时间窗: Study day 1
* centre-based * triangle test (ability to identify the odd sample correctly)
Change in child development scores on the Malawi Developmental Assessment Tool (MDAT)
时间窗: 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
Change in Responsive care and learning opportunities in the home environment: Home Observation for the Measurement of the Environment (HOME) Inventory score
时间窗: 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
次要结局
- Sensory perceptions of dishes cooked with multiple micronutrient-fortified bouillon cubes(Study day 9)
- Household-level consumption of salt(Study day 0)
- Household-level consumption of bouillon(Study day 0)
- Change in willingness to pay for multiple micronutrient-fortified bouillon cubes(Study day 1 and 17)
- Themes from focus group discussions(Study day 2 and 17)
- Perceived health effects of using study-provided multiple micronutrient-fortified bouillon cubes(Study day 17)
研究者
Reina Engle-Stone, Ph.D
Assistant Professor
University of California, Davis