NCT04287764

Brief Summary

The purpose of this study is to assess the test-retest reliability of an infant RRV paradigm which will allow researchers to study food reinforcement among infant of 9-18 months of age. By understanding the origins of food reinforcement, future interventions can be conducted to help overweight and obese population to alter their reinforcing values of food at a young age, perhaps during infancy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

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

January 2, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2016

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

February 24, 2020

Last Update Submit

October 16, 2020

Conditions

Infant Obesity

Outcome Measures

Primary Outcomes (1)

  • FRR

    The primary outcome is the reliability of the food reinforcing ratio.

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Weight status

    through study completion, an average of 1 year

Eligibility Criteria

Age9 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Infants ages 9-18 months

You may qualify if:

  • Infant must be between the ages of 9 to 18 months old
  • Infant must appear to be healthy
  • Infant of singleton (i.e. not twin or multiple)
  • Infant not allergic to puffed grains or Original Cheerios

You may not qualify if:

  • Infant of pre-mature or pre-term birth (\< 37 weeks of gestation)
  • Infant of low birth weight (\<2500 grams)
  • Infant with medical problems at birth
  • Infant with developmental delay based on developmental milestones recorded at 6 or 9 month check up
  • Infant who has not eaten the test food due to allergy concern
  • Maternal age \< 18 years
  • Mother who smoked, used controlled substances (i.e. opiates, cocaine, marijuana) or consumed excessive alcohol during pregnancy
  • Mother who had a high-risk pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kai ling Kong

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2020

First Posted

February 27, 2020

Study Start

January 2, 2016

Primary Completion

June 20, 2016

Study Completion

November 11, 2016

Last Updated

October 20, 2020

Record last verified: 2020-10