SNAK: Study of Nutrition and Activity in Kids

• Sponsor: State University of New York at Buffalo (Other)
• Overall Status: Completed
• CT.gov ID: NCT04027608
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 273
• Actual Duration (Months): 56

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Adolescent; Adolescent Behavior	Other: Reinforcing value of HED and LED foods in response to snack food monotony

Study Design

• Study Type: Observational
• Actual Enrollment: 273 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Sensitization of the Reinforcing Value of Food as a Predictor of Weight Change in Adolescents
• Actual Study Start Date: Jun 29, 2016
• Actual Primary Completion Date: Jan 30, 2021
• Actual Study Completion Date: Feb 28, 2021

Outcome Measures

Primary Outcome Measures

1. Weight Change [6, 15, and 24 months from baseline.]

   BMI z-score change over time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts 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 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jennifer Temple, Associate Professor, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT04027608
• Other Study ID Numbers: STUDY00000042; R01DK106265
• First Posted: Jul 22, 2019
• Last Update Posted: Apr 19, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jennifer Temple, Associate Professor, State University of New York at Buffalo: adolescent; obesity; relative reinforcing value; physical activity; weight change
• Additional relevant MeSH terms: Pediatric Obesity

Study Results

No Results Posted as of Apr 19, 2021