N/A
N=237
Habituation to Food as a Risk Factor for Pediatric Obesity
Obesity in Children
Bottom Line
View on ClinicalTrials.gov: NCT02229552 ↗Enrolled (actual)
237
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Change in zBMI — -0.048; 0.013; 0.011 z-score — p=0.051
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standardized Assessments (Other)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in zBMI |
-0.048; 0.013; 0.011 | 0.051 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02229552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.