Study of Nutrition and Activity in Kids (SNAK)

January 6, 2023 updated by: Jennifer Temple, State University of New York at Buffalo

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

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adolescents living in the Western New York area, aged 12-14 years at the time of enrollment. Flyers were posted in the community within a 30 min drive of UB South Campus. Additionally, flyers were sent to list serves, posted on facebook, and distributed to both private and public schools within a 40 min drive of the university campus.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 24 months from baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2016

Primary Completion (Actual)

January 30, 2021

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

July 18, 2019

First Submitted That Met QC Criteria

July 19, 2019

First Posted (Actual)

July 22, 2019

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00000042
  • R01DK106265 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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