NCT02229552

Brief Summary

The study is designed to assess habituation of behavioral responding for food as risk factors for increases in Standardized Body Mass Index (zBMI) over two years in non-overweight children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 1, 2014

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

October 26, 2020

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

1.4 years

First QC Date

July 18, 2014

Results QC Date

June 24, 2019

Last Update Submit

October 1, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in zBMI

    To assess the rate of habituation of behavioral responding to savory, sweet and salty foods as independent or interactive risk factors for zBMI trajectories, with the hypothesis that the rate of habituation of behavioral responding for food predicts zBMI trajectories over time, controlling for child gender, parental education, parental BMI, physical activity, ethnicity, the reinforcing value of food and eating in the absence of hunger.

    2 years

Study Arms (1)

Baseline Cohort

OTHER

Children completed body weight and other measures at baseline, 1-year follow up and 2-year follow up measurement periods.

Other: Standardized Assessments

Interventions

Children were asked to attend appointments without consuming study foods 24 hours previously, as habituation measurements are sensitive to recent consumption. Children were provided access to snack prior to completing questionnaires or cognitive assessments. Habituation to food, questionnaires and cognitive assessments were re-measured at 1-year and 2-year follow up.

Baseline Cohort

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • Participants will include children who are at the 50th BMI percentile and less than the 85th BMI percentile (BMI = kg/m2) at baseline. We will also include children who are below the 50th percentile, but have at least one biological parent with a current BMI ≥ 25 kg/m2.

You may not qualify if:

  • Food allergies or special diets: Youth should have no dietary restrictions that could interfere with these experiments, including food allergies or religious or ethnic practices that limit food choice or medical conditions which alter nutritional status or intestinal absorption (e.g. inflammatory bowel disease).
  • Activity restrictions: Children who have activity restrictions due to medical or physical problems, such as uncontrolled exercise induced asthma or a disability requiring wheelchair use will not participate.
  • Psychopathology, medications or sickness: Children should have no psychopathology (e.g. childhood schizophrenia) or developmental disabilities that would limit participation. Children will also be excluded if they are taking medications that could affect their level of activity or appetite (e.g. methylphenidate).
  • Moderate or greater liking of study foods. Children must report at least a moderate liking ( 3 or greater on a 5-point Likert-type scale) of the foods used in these studies and be willing to consume them.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

Location

Related Publications (3)

  • Epstein LH, Carr KA, O'Brien A, Paluch RA, Temple JL. High reinforcing value of food is related to slow habituation to food. Eat Behav. 2020 Aug;38:101414. doi: 10.1016/j.eatbeh.2020.101414. Epub 2020 Jul 29.

  • Epstein LH, Carr KA, Scheid JL, Gebre E, O'Brien A, Paluch RA, Temple JL. Taste and food reinforcement in non-overweight youth. Appetite. 2015 Aug;91:226-32. doi: 10.1016/j.appet.2015.04.050. Epub 2015 Apr 16.

  • Kong KL, Feda DM, Eiden RD, Epstein LH. Origins of food reinforcement in infants. Am J Clin Nutr. 2015 Mar;101(3):515-22. doi: 10.3945/ajcn.114.093237. Epub 2015 Jan 14.

Related Links

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Leonard H Epstein
Organization
SUNY Buffalo

Study Officials

  • Leonard Epstein, Ph.D.

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Children completed measurements of body weight, habituation to food, questionnaires and cognitive assessments in a repeated assessment prospective study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 18, 2014

First Posted

September 1, 2014

Study Start

November 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

October 26, 2020

Results First Posted

October 26, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations