Trial Outcomes & Findings for Habituation to Food as a Risk Factor for Pediatric Obesity (NCT NCT02229552)

Last Updated: 2020-10-26

Results Overview

To assess the rate of habituation of behavioral responding to savory, sweet and salty foods as independent or interactive risk factors for zBMI trajectories, with the hypothesis that the rate of habituation of behavioral responding for food predicts zBMI trajectories over time, controlling for child gender, parental education, parental BMI, physical activity, ethnicity, the reinforcing value of food and eating in the absence of hunger.

Recruitment status

COMPLETED

Study phase

Target enrollment

237 participants

Primary outcome timeframe

2 years

Results posted on

2020-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	Baseline Cohort All children completed the same baseline measures
Baseline STARTED	237
Baseline COMPLETED	231
Baseline NOT COMPLETED	6
1-year Follow up STARTED	231
1-year Follow up COMPLETED	206
1-year Follow up NOT COMPLETED	25
2-Year Follow up STARTED	231
2-Year Follow up COMPLETED	205
2-Year Follow up NOT COMPLETED	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Baseline Cohort All children completed the same baseline measures
Baseline Withdrawal by Subject	6
1-year Follow up Withdrawal by Subject	7
1-year Follow up Lost to Follow-up	18
2-Year Follow up Withdrawal by Subject	9
2-Year Follow up Lost to Follow-up	17

Baseline Characteristics

Habituation to Food as a Risk Factor for Pediatric Obesity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baseline Cohort n=231 Participants All children completed measures of habituation to food, questionnaires and cognitive assessments at baseline and 1-year and 2-year follow up periods.
Age, Continuous	10.45 years STANDARD_DEVIATION 1.44 • n=93 Participants
Sex: Female, Male Female	120 Participants n=93 Participants
Sex: Female, Male Male	111 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	215 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	4 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	33 Participants n=93 Participants
Race (NIH/OMB) White	170 Participants n=93 Participants
Race (NIH/OMB) More than one race	22 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Height	142.89 Centimeters STANDARD_DEVIATION 11.4 • n=93 Participants
Weight	78.33 pounds STANDARD_DEVIATION 18.28 • n=93 Participants
Body Mass Index	17.15 kg/m^2 STANDARD_DEVIATION 1.77 • n=93 Participants
Body Composition	16.52 Percent body fat STANDARD_DEVIATION 5.95 • n=93 Participants
zBMI	-0.039 z-score BMI STANDARD_DEVIATION 0.72 • n=93 Participants

PRIMARY outcome

Timeframe: 2 years

Population: 205 children completed baseline, year one height and weight measures and year two follow up height and weight measures

Outcome measures

Outcome measures
Measure	Baseline Cohort n=205 Participants All children completed the same baseline measures
Change in zBMI Baseline Measures	-0.048 z-score Standard Deviation 0.744
Change in zBMI 1-year follow up measures	0.013 z-score Standard Deviation 0.759
Change in zBMI 2-year follow up measures	0.011 z-score Standard Deviation 0.807

Adverse Events

Baseline Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Leonard H Epstein

SUNY Buffalo

Phone: 716-826-3400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place