Study of Nutrition and Activity in Kids

Completed

• Conditions: Adolescent Behavior; Obesity, Adolescent

• Registration Number: NCT04027608
• Lead Sponsor: State University of New York at Buffalo

Brief Summary

While a substantial body of research suggests that RRV is related to obesity, there is very little research on factors that contribute to the RRV of food, particularly how patterns of eating can increase or decrease the motivation to eat specific foods. Previous work has demonstrated that a subset of individuals with obesity show increases in RRV of food after repeated consumption of large portions of high energy density (HED) snack foods, which has been conceptualized as sensitization. Preliminary data suggest that sensitization of the RRV of HED food is a predictor of weight gain over time. However, more work needs to be done to address this relationship using a planned, prospective study design, using adolescent research subjects, and examining potential moderators of this relationship.

The purpose of this study is to identify risk and protective factors to excess zBMI change in adolescents over time. Aim 1 was to measure the relative reinforcing value (RRV) of a preferred HED and low energy density (LED) snack food before and after 2-weeks of daily exposure. Aim 2 was to assess the RRV of exercise and sedentary activity. Hypotheses include 1) sensitization to HED food will be associated with greater zBMI at the time of testing as well as greater zBMI change over time 2) sensitization to LED food will be associated with lower zBMI at the time of testing in adolescents and less zBMI change over time. 3) Greater RRV of exercise will be protective against zBMI increases over time.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-29
• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-07-19
• Study First Posted: 2019-07-22
• Primary Completion: 2021-01-30
• Study Completion: 2021-02-28
• Results First Submitted: 2022-05-03
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-06
• Last Update Submitted: 2023-01-06
• Results First Posted: 2023-01-10
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

• between 12-14yoa (male and female)
• zBMI: -1.5 to +2.0 (*determined by Height/weight measurement at Visit 1)
• neutral or higher liking of the study foods
• Willingness to complete 9 study visits over 2 years.

Exclusion Criteria

• -metabolic or endocrine disorder
• use of medications known to effect appetite (Ritalin, Adderall, Concerta, Wellbutrin, Prednisone, etc)
• Unwilling to complete the study visits
• allergy to study foods
• dislike of study foods (*determined via Preference for Study foods forms at Visit 1)
• parent report that child reads below 4th grade reading level
• parent report that child cannot complete light physical activity without assistance
• No English Speaking parent or legal guardian (therefore cannot provide consent in English nor answer questionnaires for this study) * all other exclusion criteria are assessed from Survey monkey screening in advance of the first appointment vis parental report. At the first appointment the child is directly asses for height, weight, and The linking of study foods.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
zBMI Change	through study completion, an average of 24 months from baseline.	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.