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Study of Nutrition and Activity in Kids

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04027608
Acronym
SNAK
Enrollment
201
Registered
2019-07-22
Start date
2016-06-29
Completion date
2021-02-28
Last updated
2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior, Obesity, Adolescent

Keywords

adolescent, obesity, relative reinforcing value, physical activity, weight change

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.

Interventions

OTHERReinforcing 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.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
State University of New York at Buffalo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 14 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
zBMI Changethrough 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.

Participant flow

Recruitment details

Participants were 201 boys and girls aged 12 - 14 years without obesity recruited using flyers, e-mail and social media, personal referrals, and advertisements distributed in schools in the Buffalo, NY area.

Participants by arm

ArmCount
Satiators
Participants who decreased responding for high energy density food after consuming it every day for 2 weeks.
165
Sensitizers
Participants who increased responding for high energy density food after consuming it every day for 2 weeks.
36
Total201

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up204
Overall StudyPhysician Decision10
Overall StudyProtocol Violation21
Overall StudyWithdrawal by Subject132

Baseline characteristics

CharacteristicSensitizersTotalSatiators
Age, Continuous13.2 years
STANDARD_DEVIATION 0.845
13.3 years
STANDARD_DEVIATION 0.828
13.3 years
STANDARD_DEVIATION 0.827
Race/Ethnicity, Customized
Race
American Indian/Alaska Native
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Race
Asian/Pacific Islander
0 Participants3 Participants3 Participants
Race/Ethnicity, Customized
Race
Black/African American
3 Participants23 Participants20 Participants
Race/Ethnicity, Customized
Race
Other/Mixed Race
0 Participants14 Participants14 Participants
Race/Ethnicity, Customized
Race
White or Caucasian
33 Participants160 Participants127 Participants
Region of Enrollment
United States
36 participants201 participants165 participants
Sex: Female, Male
Female
16 Participants104 Participants88 Participants
Sex: Female, Male
Male
20 Participants97 Participants77 Participants
zBMI0.48 z score
STANDARD_DEVIATION 0.84
0.40 z score
STANDARD_DEVIATION 0.99
0.38 z score
STANDARD_DEVIATION 1.02

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1650 / 36
other
Total, other adverse events
0 / 1650 / 36
serious
Total, serious adverse events
0 / 1650 / 36

Outcome results

Primary

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.

Time frame: through study completion, an average of 24 months from baseline.

Population: We began with 165 and 36, but we lost several participants in each group for various reasons which are outlined in an earlier section.

ArmMeasureGroupValue (MEAN)Dispersion
SatiatorszBMI Change6 months0.433 z-scoreStandard Error 0.073
SatiatorszBMI Change15 months0.376 z-scoreStandard Error 0.093
SatiatorszBMI Change24 months0.416 z-scoreStandard Error 0.11
SensitizerszBMI Change6 months0.55 z-scoreStandard Error 0.14
SensitizerszBMI Change15 months0.61 z-scoreStandard Error 0.18
SensitizerszBMI Change24 months0.593 z-scoreStandard Error 0.25

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026