Hummus for Health: Dietary Quality and Health Outcomes in Toddlers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Children's Healthy Eating Index total score
研究概览
简要总结
The goal of this study is to examine the effect of increasing children's intake of fiber and unsaturated fat, through daily servings of hummus and vegetables, on their microbiome profile.
详细描述
Population: The investigators will recruit 104 children ages 12-24 months from daycare centers in the Houston and surrounding areas.
Study design: The study will be conducted at daycare centers and will consist of three phases - a 'lead in period' (two weeks) where baseline measurements will be taken followed by an 'Introductory period' (three weeks) where the new food will be introduced on three days during snack time for three weeks. The introductory phase will be followed by the 'intervention period' (three weeks) where children will receive daily servings of hummus and vegetables.
Lead in period (two weeks): Two 24-hour dietary recalls will be conducted on each child (parent-report); one 24-hour dietary recall (over a weekend) will be conducted on each parent (self-report). Three dirty diapers will be collected within the time span of a week for microbiome analysis.
Introductory period (three weeks): Since children typically take several introductions of a new food to accept it, and the investigators wish to ensure a high acceptance of hummus, the investigators will spend three weeks introducing the food. The food will be provided on three days during snack time for three weeks. Prior to introducing the food, children will receive a 'lesson' involving information about vegetables using a combination of songs, rhymes and craft activities. Following the lesson, hummus and vegetables will be provided in the hummus group; vegetables only in the control group. Hummus will be provided in a pre-packaged 2 ounce serving cup; vegetables will conform to age-appropriate servings designated by the American Academy of Pediatrics (AAP) and will consist of soft vegetables (e.g., winter squash) and lightly steamed, but chilled, hard vegetables (e.g., carrots, broccoli).
Intervention period (three weeks): Similar to the introductory period, a serving of either hummus and vegetables or vegetables only will be provided to the children during snack time. The food will be provided daily for three weeks. In the final week of the intervention period, two 24-hour dietary recalls (one weekday and one weekend) will be conducted on the child (parent-report). In addition, one weekend 24-hour dietary recall will be conducted on the parent (self-report). Three dirty diapers will be collected on the child during the final week for microbiome analysis.
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
- Single (Participant)
入排标准
- 年龄范围
- 12 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between the ages of 12 and 24 month old.
- •Children attending daycare at least 3 days a week.
- •Children with a parental-report of being hummus-naive.
排除标准
- •Any child following a specific dietary regimen or that has religious restrictions or food allergies that may affect food consumption.
- •Children with parent-reported antibiotic use in the previous 6 months.
研究组 & 干预措施
Hummus and vegetables
Children will receive a lesson about vegetables and hummus and vegetables as part of their daily snack.
干预措施: Lesson about vegetables (Other)
Hummus and vegetables
Children will receive a lesson about vegetables and hummus and vegetables as part of their daily snack.
干预措施: Vegetables (Other)
Hummus and vegetables
Children will receive a lesson about vegetables and hummus and vegetables as part of their daily snack.
干预措施: Hummus (Other)
Vegetables only
Children will receive a lesson about vegetables and vegetables as part of their daily snack.
干预措施: Lesson about vegetables (Other)
Vegetables only
Children will receive a lesson about vegetables and vegetables as part of their daily snack.
干预措施: Vegetables (Other)
结局指标
主要结局
Children's Healthy Eating Index total score
时间窗: 8 weeks
Parent-report of 24-hour dietary recalls of the child's consumption will be used for this measure.
Children's daily consumption of vegetables
时间窗: 8 weeks
Parent-report of 24-hour dietary recalls of the child's consumption will be used for this measure.
Children's microbiome profile
时间窗: 8 weeks
For this measure stool samples from the children will be collected.
Children's daily consumption of greens and beans
时间窗: 8 weeks
Parent-report of 24-hour dietary recalls of the child's consumption will be used for this measure.
Children's daily consumption of unsaturated fats
时间窗: 8 weeks
Parent-report of 24-hour dietary recalls of the child's consumption will be used for this measure.
次要结局
- Parent's Healthy Eating Index total score(8 weeks)
- Parent's daily consumption of greens and beans(8 weeks)
- Parent's daily consumption of vegetables(8 weeks)
- Parent's daily consumption of unsaturated fats(8 weeks)
研究者
Sheryl Hughes
Associate Professor
Baylor College of Medicine