NCT02572258已完成不适用
The Effect of Supplementary Food Cookies on Prevention of Moderate Malnutrition in Preschool Children in Rural Mexico
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,048
- 试验地点
- 1
- 主要终点
- Weight (kg) for height (cm) Z-score
研究概览
简要总结
The study will evaluate the impact of a supplementary food (cookies) in preventing the risk of developing moderate acute malnutrition (MAM) in preschool mildly malnourished children.
Children will be divided in two groups; one will received the cookie plus 12 educative sessions and the other just the educative program. The study will last 12 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(2-5 years old), who are from low socioeconomic classes (E and D classes)
- •reside in rural areas, and with WHZ- between > -3 and ≤ -2, and
- •informed consent given by the subject's mother or caregiver
排除标准
- •Severe acute malnutrition (HAZ, WAZ and WHZ-scores ≤-3) based on the 2006 World Health Organization (WHO) reference values (24)
- •Vitamin A deficiency (softening, ulceration, cloudiness of the cornea, and dryness of the conjunctivitis), and iodine deficiency (visible goiter)
- •(3 or more episodes of loose/liquid stools/per day and lasted more than 24-hours), fever (high temperature that lasted more than 24 hours as reported by the mother/caregiver), and respiratory infections (coughing and/or runny nose that last more than 24 hours).
- •Current consumption of other supplementary foods.
- •Peanut or other ingredient allergy based on prior report. If some direct family member is allergic to peanuts, child would not be enrolled.
研究组 & 干预措施
Nutritional oats cookie and educational session
Experimental
Nutritional cookie with oats and nuts
干预措施: Nutritional cookie (Other)
Educational session only
No Intervention
结局指标
主要结局
Weight (kg) for height (cm) Z-score
时间窗: 12 months
次要结局
- Weight (kg) gains(12 months)
- weight (kg) for age (months) Z-score(12 months)
- height (cm) for age (months) Z-score(12 months)
- Mid-upper arm circumference (cm) (MUAC)(12 months)
- height (cm) gains(12 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety Evaluation and Effect of Food Supplement Containing Dietary Fiber From Cassava on the Alterations of Physiological Parameters in Overweight Female VolunteersOverweightNCT04013490Khon Kaen University75
已完成
不适用
Effectiveness of a Dietary Counseling to Prevent Early Consumption of Added Sugar and Ultra-processed FoodsInfant Nutrition DisordersFeeding PatternsHealth Knowledge, Attitudes, PracticeNCT03841123Federal University of Health Science of Porto Alegre516
Unknown
不适用
Food Supplements Based on Nettle and Peppermint to Control Signs and Symptoms Induced by Cancer TherapiesGynecologic CancerBreast CancerNCT04474951IRCCS Azienda Ospedaliero-Universitaria di Bologna60
已完成
不适用
Effects of a Supplement on Acute Respiratory InfectionsRespiratory Tract InfectionNCT02210156Omnilife Manufactura, SA de CV45
Unknown
不适用
Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn DiseaseCrohn DiseaseUlcerative ColitisNCT03941418University Clinic Dr Dragisa Misovic-Dedinje150