NCT07524907招募中不适用
STRIKE: Stunting and Targeting Reduction of Impaired Growth in Kids Effectively: A Community Engaged Comprehensive, Multi-Faceted Nutrition Quality Improvement Program
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Program Feasibility
研究概览
简要总结
The objective of this prospective, real-world evidence/pragmatic study with a quality improvement program approach is to evaluate the feasibility and effectiveness of a community-engaged nutrition-focused program utilizing nutrition screening, education, supplementation and continuous follow up for children and their families.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Household Component
- •Children aged 1-5 years experiencing stunting or its risk (defined as HAZ ≤ -1 SD at baseline)
- •Children's legal guardian agrees to participate in the study
- •Full term pregnancy (defined as ≥ 37 weeks gestation and ≥ 2500g birth weight)
- •Residence in study area attending Children International (NGO) centers
- •Children who have current medical conditions requiring hospitalization: gastrointestinal tract infections or inflammatory bowel disease; active tuberculosis; acute hepatitis B or C; human immunodeficiency virus OR malignancy; cystic fibrosis; immunodeficiency syndromes, congenital abnormalities of the respiratory tract, such as lung and respiratory cilia; an unsuspected foreign body in the respiratory tract; asthma; heart abnormalities; abdominal hernias; and known metabolic disorders, renal impairment, or rheumatic diseases and diabetes
- •Congenital condition
- •Children with disabilities such as cerebral palsy, autism spectrum disorder, neurodegenerative disorders
- •Children with chronic or acute infections e.g. HIV, malaria
- •Children who are taking medications or other agents that could potentially affect body weight, including diuretics, appetite stimulants, steroids, and growth hormones
- •Children who have genetic conditions impacting weight status such as but not limited to: Bardet-Biedl Syndrome, Prader-Willi Syndrome
- •Children already enrolled in a nutrition program that includes a supplement
- •Participant has an allergy or intolerance to any ingredient in the study supplement, as reported by the parent.
- •Children with sleep disorders such as but not limited to: obstructive sleep apnea, insomnia, parasomnias (sleepwalking, night terrors, bedwetting), delayed sleep phase syndrome, behavioral sleep disorders, circadian rhythm disorders
- •Mental health disorders such as but not limited to: anxiety, depression
- •Organization Component
- •NGO staff taking part in nutrition screenings
- •Agrees to participate in survey
- •Not involved in the implementation of the study
- •Not involved in working with pediatric stunting or its risk
- •Declines participation in survey
排除标准
- 未提供
研究组 & 干预措施
Organization
NGO Staff
Household
Includes eligible Children and their Caregivers
结局指标
主要结局
Program Feasibility
时间窗: Baseline to 12 months
Caregiver and NGO staff program experience assessed via survey via Net Promoter Score (NPS) scored from 0 to 10 where higher score is more favorable
Growth Anthropometrics
时间窗: Baseline to 3, 6, 9, and 12 months
Change in Height (cm), Head Circumference (cm), Weight (kg) and Mid-Upper Arm Circumference (MUAC) (mm) as compared to pediatric growth standards (i.e. percentiles and z-scores)
次要结局
- Healthcare Resource Utilization(Baseline, 6 and 12 months)
- Pediatric Quality of Life Inventory(Baseline, 6, and 12 months)
- World Health Organization Quality of Life Brief Version(Baseline, 6, and 12 months)
- Nutrient Intake(Baseline, 3, 6, 9, and 12 months)
- Pediatric Nutrition Risk Status via Anthropometrics(Baseline, 3, 6, 9, and 12 months)
研究者
研究点 (1)
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