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The primary objective of the study was to compare the change in z-scores for growth during a 120-day study period in children with picky eating behaviors who were randomly assigned to receive nutrition counseling only (control group) or nutrition counseling plus an oral milk-based nutritional supplement (study group). The secondary objectives of the study were to compare the following between the control and study groups: a) dietary macro- and micro-nutrient intakes; b) quantitative ultrasound bone measurements of radius and tibia; and c) incidence of common illnesses (diarrhea, upper and lower respiratory tract). The safety objective of the study was to compare the frequency of adverse events (AE) among the control group and study group subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nutritional counseling | Other | nutritional counseling |
|
| nutritional counseling and milk-based supplement | Other | nutritional counseling plus oral milk-based nutrition supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutrition counseling plus oral milk-based nutritional supplement | Dietary Supplement | Study group subjects were instructed to consume at least 2 servings (230 mL per serving) of an oral milk-based nutritional supplement daily, in addition to their regular diet, for a total of 120 (±3) days. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors | The primary efficacy evaluation was growth, including the change in weight-for-height z-score from baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis. | baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors | Secondary efficacy evaluations included: dietary macro- and micro-nutrient intakes, quantitative ultrasound measurements of the radius and tibia, and incidence of common illnesses (diarrhea, and upper and lower respiratory tract infection). | baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors | Safety was evaluated through the recording and monitoring of adverse events. | baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoyang Sheng, Professor | Xinhua Hospital Affiliated to Shanghai Jiaotong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200092 | China | ||
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|
| nutritional counseling | Other | nutritional counseling |
|
| •Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors |
dietary macro- and micro-nutrient intakes |
| baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis |
| •Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors | quantitative ultrasound measurements of the radius and tibia | baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis |
| •Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors | and incidence of common illnesses (diarrhea, and upper and lower respiratory tract infection). | baseline to Day 120, as well as from baseline to Days 30, 60 and 90, and over the entire study period based on repeated measures analysis |
| Xinhua Hospital Affiliated to Shanghai Jiaotong |
| Shanghai |
| Shanghai Municipality |
| 200092 |
| China |
| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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