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The objective of this randomized, controlled trial is to evaluate the effects of consuming a pediatric oral nutritional supplement (ONS) plus dietary counseling for 120 days on anthropometric growth, strength, and nutritional status, compared with dietary counseling alone in undernourished children in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Nutritional Supplement (ONS) Group | Experimental | Two servings per day in addition to dietary counseling |
|
| Control Group | Other | dietary counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Nutritional Supplement | Other | ONS plus dietary counseling |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weight-for-age z-score (WAZ) | Change in weight-for-age z-score | baseline to 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric Measurement Calculations | Standard z-scores and percentiles including weight-for-age, height-for-age, weight-for-height, BMI-for-age and mid-upper-arm-circumference-for-age | baseline to 120 days |
| Mid-upper-arm circumference (MUAC) |
| Measure | Description | Time Frame |
|---|---|---|
| Hand Grip Strength | Measured in kg | baseline to 120 days |
| Nutrition Biomarkers | Blood chemistry analysis of vitamin A, vitamin B12, vitamin D, vitamin E, folate, and vitamin K |
Inclusion Criteria:
Exclusion Criteria:
Child has a height-for-age z-score ≥ 0.
Child is currently drinking an oral nutritional supplement (ONS) on a regular basis (≥ 15 days in the past month)
Child is participating in another study that has not been approved as a concomitant study by AN.
Child has been diagnosed with the following:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Williams, MPH | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midway Medical Clinic | Oneonta | Alabama | 35121 | United States | ||
| HealthStar Research Glenwood |
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| Dietary counseling |
| Other |
dietary counseling |
|
Measured in cm
| baseline to 120 days |
| Weight | Measured in Kg | baseline to 120 days |
| Height | Measured in cm | baseline to 120 days |
| Dietary Diversity | Measured by 24-hour dietary recall | baseline to 120 days |
| Appetite | Visual analog scale from Ate Very Little to Ate A Lot | baseline to 120 days |
| baseline to 120 days |
| Adverse Event Reporting | Standard adverse event reporting | baseline to 120 days |
| Health Care Utilization | Number of unscheduled visits or missed school days (child) or work days (parent) | baseline to 120 days |
| Sleep Data | Average daily number of hours | baseline to 120 days |
| Activity Data | Average daily number of minutes | baseline to 120 days |
| Physical Activity | Visual analog scale from Not Active to Very Active | baseline to 120 days |
| Parental Stress Scale | 18 questions scaled from Strongly disagree to Strongly Agree | baseline to 120 days |
| Child Eating Behavior Questionnaire | 35 questions 5-Point Likert Scale from Never to Always | baseline to 120 days |
| Caregiver Opinion Questionnaire | 3 Parent reported questions related to child's nutrition | baseline to 120 days |
| Children's Sleep Habit Questionnaire | 7 Parent reported questions related to child's sleep habits | baseline to 120 days |
| Triceps Skinfold | Measured in mm | baseline to 120 days |
| Glenwood |
| Arkansas |
| 71943 |
| United States |
| HealthStar Research, LLC | Hot Springs | Arkansas | 71913 | United States |
| L.A. Universal Research Center, Inc. | Los Angeles | California | 90057 | United States |
| Kissimmee Clinical Research | Kissimmee | Florida | 34743 | United States |
| Dade Research Center, LLC | Miami | Florida | 33126 | United States |
| D&H National Research Centers | Miami | Florida | 33155 | United States |
| Suncoast Research, Assoc., LLC | Miami | Florida | 33173 | United States |
| Springs Medical Research | Owensboro | Kentucky | 42303 | United States |
| Velocity Clinical Research | Covington | Louisiana | 70433 | United States |
| Southern Clinical Research | Zachary | Louisiana | 70791 | United States |
| Alivation Research (Primary Care) | Lincoln | Nebraska | 68526 | United States |
| Javara Inc. 3380 | Winston-Salem | North Carolina | 27103 | United States |
| Tribe Clinical Research LLC. | Greenville | South Carolina | 29607 | United States |
| Javara, Inc. 3377 | Dallas | Texas | 75230 | United States |
| Proactive Clinical Research | Edinburg | Texas | 78539 | United States |
| Gentle Pediatrics | Sugar Land | Texas | 77479 | United States |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| 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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