Trial Outcomes & Findings for Study of Nutrition and Activity in Kids (NCT NCT04027608)
NCT ID: NCT04027608
Last Updated: 2023-01-10
Results Overview
BMI z-score change over time. zBMI is a standardized index of body mass index used in children that is standardized to age and sex specific measurements from a national sample. 0 represents the national average. A positive number reflects a body mass index that is higher than the national average and a negative number reflects a body mass index that is lower than the national average.
COMPLETED
201 participants
through study completion, an average of 24 months from baseline.
2023-01-10
Participant Flow
Participants were 201 boys and girls aged 12 - 14 years without obesity recruited using flyers, e-mail and social media, personal referrals, and advertisements distributed in schools in the Buffalo, NY area.
Participant milestones
| Measure |
Satiators
Participants who decreased responding for high energy density food after consuming it every day for 2 weeks.
|
Sensitizers
Participants who increased responding for high energy density food after consuming it every day for 2 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
165
|
36
|
|
Overall Study
COMPLETED
|
129
|
29
|
|
Overall Study
NOT COMPLETED
|
36
|
7
|
Reasons for withdrawal
| Measure |
Satiators
Participants who decreased responding for high energy density food after consuming it every day for 2 weeks.
|
Sensitizers
Participants who increased responding for high energy density food after consuming it every day for 2 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
2
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
20
|
4
|
Baseline Characteristics
Study of Nutrition and Activity in Kids
Baseline characteristics by cohort
| Measure |
Satiators
n=165 Participants
Participants who decreased responding for high energy density food after consuming it every day for 2 weeks.
|
Sensitizers
n=36 Participants
Participants who increased responding for high energy density food after consuming it every day for 2 weeks.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.3 years
STANDARD_DEVIATION 0.827 • n=5 Participants
|
13.2 years
STANDARD_DEVIATION 0.845 • n=7 Participants
|
13.3 years
STANDARD_DEVIATION 0.828 • n=5 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian/Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian/Pacific Islander
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African American
|
20 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White or Caucasian
|
127 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other/Mixed Race
|
14 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
165 participants
n=5 Participants
|
36 participants
n=7 Participants
|
201 participants
n=5 Participants
|
|
zBMI
|
0.38 z score
STANDARD_DEVIATION 1.02 • n=5 Participants
|
0.48 z score
STANDARD_DEVIATION 0.84 • n=7 Participants
|
0.40 z score
STANDARD_DEVIATION 0.99 • n=5 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 24 months from baseline.Population: We began with 165 and 36, but we lost several participants in each group for various reasons which are outlined in an earlier section.
BMI z-score change over time. zBMI is a standardized index of body mass index used in children that is standardized to age and sex specific measurements from a national sample. 0 represents the national average. A positive number reflects a body mass index that is higher than the national average and a negative number reflects a body mass index that is lower than the national average.
Outcome measures
| Measure |
Satiators
n=165 Participants
Participants who decreased responding for high energy density food after consuming it every day for 2 weeks.
|
Sensitizers
n=36 Participants
Participants who increased responding for high energy density food after consuming it every day for 2 weeks.
|
|---|---|---|
|
zBMI Change
6 months
|
0.433 z-score
Standard Error 0.073
|
0.55 z-score
Standard Error 0.14
|
|
zBMI Change
15 months
|
0.376 z-score
Standard Error 0.093
|
0.61 z-score
Standard Error 0.18
|
|
zBMI Change
24 months
|
0.416 z-score
Standard Error 0.11
|
0.593 z-score
Standard Error 0.25
|
Adverse Events
Satiators
Sensitizers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jennifer Temple, Principle Investigator
University at Buffalo
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place