The goal of this clinical trial is to investigate the effect of high caloric oral nutritional supplements on body proportion, weight, linear growth pattern, neuropsychological development level and related health aspects (gut health, immune function, quality of life, etc.) in participants aged 1 to 3 years who are malnourished (underweight and wasting),as well as to evaluate the safety of applying high caloric oral nutritional supplements. Participants will receive nutritional education and daily high caloric oral nutritional supplements(experimental group),or will receive nutritional education and dietary instruction(control group).This study may provide data to support the development of clinical intervention strategies for malnourished Chinese children.
Aged 1-3 years
BMI for Age Z-score<-2
Height-for-age z score<-2
Total daily energy intake<75% of recommended nutrient intake
Chronic or severe infectious disease (e.g., chronic hepatitis, HIV or tuberculosis infection)
Certain congenital or genetic diseases affecting physical growth and development (congenital heart disease, Down's syndrome, infantile anorexia nervosa, etc.), malignancies and use of drugs (diuretics, appetite stimulants, steroids and growth hormones, etc.)
Severe gastrointestinal disorders (e.g., celiac disease, short bowel syndrome, inflammatory bowel disease, etc.)
Acute and chronic respiratory/digestive tract infections within 2 weeks prior to enrollment
Parallel
high caloric oral nutritional supplements
Dietary supplementHigh caloric oral nutritional supplements (which can supplement 30% of the energy requirement) is given daily, and the recommended amount of energy and protein is referred to the 2013 Chinese Dietary Nutrient Reference Intake Table. At 6 months of enrollment, participants will be asked to evaluate whether to continue feeding according to the experimental group protocol or to stop to ensure proper nutritional intake.
nutritional education
BehavioralAfter enrollment,health education information is pushed approximately every 4 weeks through the WeChat platform or/and short text messages to parents.
dietary guidance
BehavioralAt follow-up visits at 0, 1, 2, 3, 6,and 12 months after enrollment, a professionally trained pediatrician give the participant's guardian dietary instructions appropriate to the age stage and physical condition of the child. Each session lasts approximately 10 minutes.
BMI for Age Z-score(BAZ)
Trained research assistants or health care practitioners obtain weight in kilograms and height in centimeters (mean of 3 consecutive measurements). Height and weight will be combined to report BMI in kg/m\^2.Then, the BAZ is calculated using WHO2011v3.2.2 software.
Dietary Diary
Participants provide a dietary diary over an average two-day period through a WeChat app each visit. The app prompts participants to record and estimate details of all meals and snacks they consumed, especially formula used in the study.
BMI for Age Z-score(BAZ)
Trained research assistants or health care practitioners obtain weight in kilograms and height in centimeters (mean of 3 consecutive measurements). Height and weight will be combined to report BMI in kg/m\^2.Then, the BAZ is calculated using WHO2011v3.2.2 software.
Weight for Age Z-score(WAZ)
Trained research assistants or health care practitioners obtain weight in kilograms using a standardized approach. Weight is measured using a precision digital scale or mechanical scale(mean of 3 consecutive measurements). Then, the WAZ is calculated using WHO2011v3.2.2 software.
Height for Age Z-score(HAZ)
Trained research assistants or health care practitioners obtain height in centimeters using a standardized approach. Height is measured with a calibrated stadiometer(mean of 3 consecutive measurements). Then, the HAZ is calculated using WHO2011v3.2.2 software.
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Children's Hospital of Chongqing Medical University
Lead sponsor
Anhui Provincial Children's Hospital
Collaborator
Baoji Maternity and Child Healthcare Hospital
Collaborator
Chengdu Women's and Children's Central Hospital
Collaborator
Guiyang Maternity and Child Health Care Hospital
Collaborator
Guangzhou Women and Children's Medical Center
Collaborator
Hunan Children's Hospital
Collaborator
Jiangxi Maternal and Child Health Hospital
Collaborator
Kunming Children's Hospital
Collaborator
Nanjing Maternity and Child Health Care Hospital
Collaborator
Children's Hospital of The Capital Institute of Pediatrics
Collaborator
Xianyang Children's Hospital
Collaborator
Nestle Health Science
Collaborator
The First Hospital of Jilin University
Collaborator
