Study of Nutrition and Activity in Kids

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.

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Key information

Conditions

Obesity, Adolescent Adolescent Behavior Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

12 year–14 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reinforcing value of HED and LED foods in response to snack food monotony

Other

Each child will be asked to eat two different snack foods over the course of two weeks each. The RRV of that food (vs alternative reinforcer) will be tested and baseline and post exposure. Increases in RRv for food after monotony will be considered sensitization to that food. All children will be followed to observe weight change over time for 2 years each.

Primary outcomes

zBMI Change

Time frame: 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.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Sensitization of the Reinforcing Value of Food as a Predictor of Weight Change in Adolescents

Acronym: SNAK

Important dates

Study start: 2016
Primary completion: 2021
Study completion: 2021
First posted: Jul 22, 2019
Registry last updated: Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed