Picky Eating Behaviors
Conditions
Keywords
Children with picky-eating behaviors, Children aged 2.5 - 5 years, reported by caregivers, with weight-for-height z-scores ≤ 25th percentile at enrollment
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTnutrition counseling plus oral milk-based nutritional 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.
OTHERnutritional counseling
nutritional counseling
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Months to 60 Months
Healthy volunteers
No
Inclusion criteria
* Children aged 30-60 months with PE behavior as reported by caregivers and whose weight-for-height was ≤25th percentile according to World Health Organization (WHO) Child Growth Standards were eligible for inclusion.
Exclusion criteria
* Current acute or chronic illness, food allergies, lactose intolerance, dietary restrictions precluding dairy foods, any genetic disorder that may compromise growth and/or food intake, cognitive or developmental disorders, or medications that may influence study outcomes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors | 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. | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors | 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. | Safety was evaluated through the recording and monitoring of adverse events. |
| •Effect of a new growing-up milk on growth and nutrient adequacy in children with picky-eating behaviors | 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 | dietary macro- and micro-nutrient intakes |
Countries
China
Outcome results
None listed