Study of Nutrition and Activity in Kids

NCT ID: NCT04027608

Last Updated: 2023-01-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-29

Study Completion Date

2021-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity, Adolescent Adolescent Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

NIH

Sponsor Role collaborator

State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jennifer Temple

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

Balantekin KN, Andrade ALP, Ziegler AM, Temple JL. Restriction and Pressure to Eat Are Associated Cross-Sectionally, But Not Longitudinally, With BMI z-Score in a Longitudinal Cohort Study of Adolescents. Child Obes. 2024 Sep;20(6):386-393. doi: 10.1089/chi.2023.0108. Epub 2023 Nov 15.

Reference Type DERIVED
PMID: 37967392 (View on PubMed)

Temple JL, Ziegler AM, Crandall AK, Mansouri T, Hatzinger L, Barich R, Epstein LH. Sensitization of the reinforcing value of high energy density foods is associated with increased zBMI gain in adolescents. Int J Obes (Lond). 2022 Mar;46(3):581-587. doi: 10.1038/s41366-021-01007-w. Epub 2021 Nov 30.

Reference Type DERIVED
PMID: 34848836 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01DK106265

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00000042

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Young Adult Eating Habits
NCT05550818 COMPLETED NA
Improving Body Image in Middle Schoolers
NCT00067652 COMPLETED PHASE1