Obesity in Children
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERStandardized 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.
Sponsors
State University of New York at Buffalo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Children completed measurements of body weight, habituation to food, questionnaires and cognitive assessments in a repeated assessment prospective study.
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* 8-12 years of age * Participants will include children who are at the 50th BMI percentile and less than the 85th BMI percentile (BMI = kg/m2) at baseline. We will also include children who are below the 50th percentile, but have at least one biological parent with a current BMI ≥ 25 kg/m2.
Exclusion criteria
* Food allergies or special diets: Youth should have no dietary restrictions that could interfere with these experiments, including food allergies or religious or ethnic practices that limit food choice or medical conditions which alter nutritional status or intestinal absorption (e.g. inflammatory bowel disease). * Activity restrictions: Children who have activity restrictions due to medical or physical problems, such as uncontrolled exercise induced asthma or a disability requiring wheelchair use will not participate. * Psychopathology, medications or sickness: Children should have no psychopathology (e.g. childhood schizophrenia) or developmental disabilities that would limit participation. Children will also be excluded if they are taking medications that could affect their level of activity or appetite (e.g. methylphenidate). * Moderate or greater liking of study foods. Children must report at least a moderate liking ( 3 or greater on a 5-point Likert-type scale) of the foods used in these studies and be willing to consume them.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in zBMI | 2 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Baseline Cohort All children completed measures of habituation to food, questionnaires and cognitive assessments at baseline and 1-year and 2-year follow up periods. | 231 |
| Total | 231 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 1-year Follow up | Lost to Follow-up | 18 |
| 1-year Follow up | Withdrawal by Subject | 7 |
| 2-Year Follow up | Lost to Follow-up | 17 |
| 2-Year Follow up | Withdrawal by Subject | 9 |
| Baseline | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Baseline Cohort |
|---|---|
| Age, Continuous | 10.45 years STANDARD_DEVIATION 1.44 |
| Body Composition | 16.52 Percent body fat STANDARD_DEVIATION 5.95 |
| Body Mass Index | 17.15 kg/m^2 STANDARD_DEVIATION 1.77 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 215 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Height | 142.89 Centimeters STANDARD_DEVIATION 11.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants |
| Race (NIH/OMB) More than one race | 22 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 170 Participants |
| Sex: Female, Male Female | 120 Participants |
| Sex: Female, Male Male | 111 Participants |
| Weight | 78.33 pounds STANDARD_DEVIATION 18.28 |
| zBMI | -0.039 z-score BMI STANDARD_DEVIATION 0.72 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 237 |
| other Total, other adverse events | 0 / 237 |
| serious Total, serious adverse events | 0 / 237 |
Outcome results
Primary
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
Population: 205 children completed baseline, year one height and weight measures and year two follow up height and weight measures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline Cohort | Change in zBMI | Baseline Measures | -0.048 z-score | Standard Deviation 0.744 |
| Baseline Cohort | Change in zBMI | 1-year follow up measures | 0.013 z-score | Standard Deviation 0.759 |
| Baseline Cohort | Change in zBMI | 2-year follow up measures | 0.011 z-score | Standard Deviation 0.807 |
p-value: 0.051ANOVA