Obesity, AdolescentSNAKNCT04027608
Study of Nutrition and Activity in Kids
An observational study of Obesity, Adolescent and Adolescent Behavior, run by State University of New York at Buffalo.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Adolescent, Adolescent Behavior
- What is being tested?
- Reinforcing value of HED and LED foods in response to snack food monotony
- How many people
- 201 participants
- Where
- No sites listed yet
- Study dates
- 29 Jun 2016to 28 Feb 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- -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.
About this study
Official title: 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.
- Conditions
- Obesity, Adolescent, Adolescent Behavior
- Being tested
- Reinforcing value of HED and LED foods in response to snack food monotony
- Keywords
- adolescent, obesity, relative reinforcing value, physical activity, weight change
- Medical subject headings
- Pediatric Obesity, Adolescent Behavior, Obesity, Motor Activity, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinforcing value of HED and LED foods in response to snack food monotonyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
zBMI Change
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.
Measured: through study completion, an average of 24 months from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start29 Jun 2016
- Primary completion30 Jan 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity, AdolescentStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Temple, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027608
- Sponsor's protocol ID
- STUDY00000042
- Other IDs
- R01DK106265
- Acronym
- SNAK
- Status last verified
- Jan 2023
- First submitted
- 18 Jul 2019
- Last updated
- 10 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37967392Temple 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.
PubMed 34848836
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitization of the Reinforcing Value of Food as a Predictor of Weight Change in Adolescents
- ClinicalTrials.gov ID
- NCT04027608
- Acronym / sponsor ID
- SNAK / STUDY00000042
- Conditions
- Obesity, Adolescent, Adolescent Behavior
- Keywords
- adolescent, obesity, relative reinforcing value, physical activity, weight change
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 29 Jun 2016 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 22 Jul 2019 (actual)
- Results
- Posted 10 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- -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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reinforcing value of HED and LED foods in response to snack food monotonyEach 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. | Other | – |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37967392Balantekin 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.
- Derived from this study: PubMed 34848836Temple 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Adolescent and Adolescent Behavior, run by State University of New York at Buffalo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
zBMI Change (time frame: through study completion, an average of 24 months from baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04027608, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.