An interventional study of Standardized Assessments in Obesity in Children, sponsored by State University of New York at Buffalo. Completed at 1 site in United States. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-26.
Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Basic science
The study is designed to assess habituation of behavioral responding for food as risk factors for increases in Standardized Body Mass Index (zBMI) over two years in non-overweight children.
Cross sectional data have shown slower habituation is related to greater energy intake, and habituation is slower for overweight/obese compared to leaner youth, but it is not known whether this is a result of being overweight, or whether slower habituation is a risk factor for weight gain. The goal of this application is to study individual differences in behavioral (responding for food) habituation as risk factors for alterations in zBMI and body fat over a two year period in 200, 8 to 12 year-old non-overweight children. This project will provide the first test of the hypothesis that slow habituation to food is a risk factor for increases in zBMI in non-overweight youth.
6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.
This study's enrollment of 237 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Children completed body weight and other measures at baseline, 1-year follow up and 2-year follow up measurement periods.
Other: Standardized Assessments
Children were asked to attend appointments without consuming study foods 24 hours previously, as habituation measurements are sensitive to recent consumption. Children were provided access to snack prior to completing questionnaires or cognitive assessments. Habituation to food, questionnaires and cognitive assessments were re-measured at 1-year and 2-year follow up.
Change in zBMI
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.
Time frame: 2 years
| Milestone | Baseline Cohort |
|---|---|
| Started | 237 |
| Completed | 231 |
| Not completed | 6 |
| Withdrew: Withdrawal by subject | 6 |
| Milestone | Baseline Cohort |
|---|---|
| Started | 231 |
| Completed | 206 |
| Not completed | 25 |
| Withdrew: Withdrawal by subject | 7 |
| Withdrew: Lost to follow-up | 18 |
| Milestone | Baseline Cohort |
|---|---|
| Started | 231 |
| Completed | 205 |
| Not completed | 26 |
| Withdrew: Withdrawal by subject | 9 |
| Withdrew: Lost to follow-up | 17 |
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.
| z-score | Baseline Cohort |
|---|---|
| Baseline Measures | -0.048 ± 0.744 |
| 1-year follow up measures | 0.013 ± 0.759 |
| 2-year follow up measures | 0.011 ± 0.807 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Baseline Cohort | 0/237 (0%) | 0/237 (0%) | 0/237 (0%) |
| Age, Continuous(years) | Baseline Cohort |
|---|---|
| Mean | 10.45 ± 1.44 |
| Sex: Female, Male(Participants) | Baseline Cohort |
|---|---|
| Female | 120 |
| Male | 111 |
| Ethnicity (NIH/OMB)(Participants) | Baseline Cohort |
|---|---|
| Hispanic or Latino | 14 |
| Not Hispanic or Latino | 215 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Baseline Cohort |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 33 |
| White | 170 |
| More than one race | 22 |
| Unknown or Not Reported | 2 |
| Height(Centimeters) | Baseline Cohort |
|---|---|
| Mean | 142.89 ± 11.4 |
| Weight(pounds) | Baseline Cohort |
|---|---|
| Mean | 78.33 ± 18.28 |
| Body Mass Index(kg/m^2) | Baseline Cohort |
|---|---|
| Mean | 17.15 ± 1.77 |
| Body Composition(Percent body fat) | Baseline Cohort |
|---|---|
| Mean | 16.52 ± 5.95 |
1 further baseline measures are reported on the registry.
Plan to share: No
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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State University of New York at Buffalo