Effectiveness of a Dietary Counseling to Prevent Added Sugar and Ultra-processed Foods During the First Year of Life: a Randomized Field Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 516
- 试验地点
- 2
- 主要终点
- Number of Participants with dental caries
研究概览
简要总结
The purpose of the study is to prevent the early introduction of added sugar and ultra-processed foods and evaluate the impact on breastfeeding duration, complementary feeding quality, growth and prevalence of caries during the first year of life.
详细描述
This randomized field trial will be performed at the maternity wards of Friendly Hospitals Initiative in three regions of Brazil: North, Northeast and South. After delivery, mothers who accepted to participate in the study will be randomized into control and intervention groups.It will be performed a weekly block randomization to prevent the contamination of information among mothers of different groups in the same facility. The intervention mothers will be advised not to give added sugar and ultra-processed foods during the first year of life, including a leaflet with colored images as a reminder for mothers. The control group mothers will not receive the study intervention but will be have all the routine health assistance of the maternity. At 6 months and 12 months, mothers of both groups will be visited in their homes and dietary evaluation and anthropometric measurements of their babies will be assessed. At 12 months of age the infants will have dental examinations and hemoglobin concentration through a capillary blood test.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborns with gestational age ≥ 37 weeks
- •single birth
- •Mother with at least 18 years old
排除标准
- •Mothers with HIV or HTLV1 positive
- •Infants with clinical occurrences or other conditions that prohibit breastfeeding or requires specific dietary treatment.
研究组 & 干预措施
Intervention
At the maternity wards mothers will receive dietary counseling and leaflets as a reminder to prevent the early introduction of added sugar and ultra-processed foods.
干预措施: Dietary Counseling (Other)
Control
At the maternity wards mothers assigned to control groups will have all the health assistance related to the maternity routine without any interference from the study protocol.
结局指标
主要结局
Number of Participants with dental caries
时间窗: 12 months
The dental examination will be performed by dentists
Exclusive breastfeeding duration
时间窗: 6 months
Proportion of infants from 0-6 months at age who are fed exclusively with breastfeeding
weight gain pattern at 6 months
时间窗: 6 months
Weight at birth and six months will be obtained and the weight gain velocity will be calculated
Anemia prevalence
时间窗: 12 months
The hemoglobin levels will be obtained by capillary blood tests
Amount of Added Sugar and ultra-processed foods consumed at 6 months
时间窗: 6 months
Information will be obtained through two not consecutive dietary 24 hour recall
Amount of Added Sugar and ultra-processed foods consumed at 12 months
时间窗: 12 months
Information will be obtained through two not consecutive dietary 24 hour recall
weight gain pattern at 12 months
时间窗: 12 months.
Weight at six months and 12 months will be obtained and the weight gain velocity will be calculated
Prevalence of continued breastfeeding at 1 year
时间窗: 12 months
Proportion of children 12 months of age who are breastfed
次要结局
- Offer of added sugar and ultra-processed foods at 6 months(6 months)
- Proportion of infants from 0-12 months of age who are fed with infant formula, cow's milk and toddler milk(12 months)
- Minimally processed foods, processed foods and total energy intake consumed at 12 months(12 months)
- Offer of added sugar and ultra-processed foods at 12 months(12 months)
- Minimally processed foods, processed foods and total energy intake consumed at 6 months(6 months)
研究者
Marcia Regina Vitolo
Professor
Federal University of Health Science of Porto Alegre