Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Study Feasibility: Recruitment
研究概览
简要总结
The goals of this study are to 1) pilot the feasibility of a novel meal kit delivery intervention in families and children with food insecurity and obesity and 2) evaluate the implementation of the pilot intervention.
详细描述
Childhood obesity prevalence is rising in the U.S. and is known to track into adulthood, increasing the risks of chronic diseases such as type 2 diabetes. Households of children with obesity also face unmet social needs, such as food insecurity. Food insecurity is associated with poorer dietary quality and higher prevalence of obesity and diabetes in adults; however, data are inconsistent and less known regarding longitudinal health effects in children. Because food insecurity and childhood obesity tend to co-occur in Black, Hispanic, and lower-income households, there is an urgent need to examine and intervene in the social determinants associated with rising childhood obesity prevalence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children >=6 years and <12 years old with a BMI >=95th percentile
- •Children who screen positive on the 2-item Hunger Vital Sign™
- •Children living in a household of <=5 people
- •Children living with an English and/or Spanish-speaking caregiver
- •Children living within the EatWell delivery map boundaries in the greater Boston area
排除标准
- •History of food allergies or intolerance to dairy, gluten, soy, or any potential component of the meal kit
- •History of malabsorptive intestinal disease (e.g., Crohn's disease, celiac disease)
- •History of type 1 or 2 diabetes
- •History of solid tumor or bone marrow transplant
- •Enteral tube dependence
- •The child's primary caregiver will be eligible for enrollment.
结局指标
主要结局
Study Feasibility: Recruitment
时间窗: 2 months to baseline
Proportion of eligible participants who were recruited and enrolled in the intervention, prior to randomization.
Study Feasibility: Randomization
时间窗: At baseline
Number of participants enrolled per month, then subject to randomization.
Study Feasibility: Retention
时间窗: At the baseline first study visit (baseline), at the second study visit (week 6-8), and at the third study visit (week 14-16).
Number of participants retained at each study visit
Study Feasibility: Protocol
时间窗: Third study visit (week 14-16)
Number of participants who reported receipt of all six weeks of meal kit delivery
Study Feasibility: Adherence - Caregivers
时间窗: Third study visit (week 14-16)
Total number of recipes prepared by caregivers
Study Feasibility: Adherence - Children
时间窗: Third study visit (week 14-16)
Number of children who tasted/ate food from the meal kit
Study Feasibility: Assessments
时间窗: At the baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)
Proportion of planned assessments completed at each study visit
次要结局
- Number of Participants With Household Food Insecurity at the First Study Visit(At the baseline first study visit (baseline))
- Number of Participants With Household Food Insecurity at Second Study Visit(At second study visit (week 6-8))
- Number of Participants With Household Food Insecurity at Third Study Visit(At third study visit (week 14-16))
- Change in BMI For Children With BMI Assessments At All Visits(At baseline, at second study visit (week 6-8), and at third study visit (week 14-16))
- Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits(At baseline, at second study visit (week 6-8), and at third study visit (week 14-16))
研究者
Allison Wu
Physician, Gastroenterology and Nutrition, Principal Investigator, Instructor of Pediatrics
Boston Children's Hospital