Brief Summary

The aim of this study is, first, to describe the evolution of the caloric compensation ability in infants from 3 to 15 months old and, secondly, to assess the links between changes in the caloric compensation ability and the individual characteristics (adiposity, age, gender, infant's eating behavior) and maternal feeding practices. Three series of measurements of caloric compensation abitlity were conducted: at 3-4 months old, at 10.5 months old and at 14.5 months old in the laboratory. In this study, a preload paradigm usually employed in children and adults to measure the caloric compensation ability was adapted to infants below 15 months old. The maternal eating behavior and their feeding practices were measured by questionnaires. The infants' height and weight were measured at the laboratory by trained experimenters.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

2.1 years

First QC Date

January 18, 2018

Last Update Submit

January 24, 2018

Conditions

Keywords

Caloric compensation

Outcome Measures

Primary Outcomes (1)

  • COMPX score

    Based on intake data, Energy Intakes (EI) were calculated according to caloric composition of the offered foods from the manufacturers. From the EI data, a COMPX score was calculated at each studied age by dividing the difference in EI from meals by the difference in EI from preloads (presented as a percentage). A COMPX score of 100% reflects a perfect caloric compensation.

    one week

Interventions

The investigators have adapted an established within-subject preload paradigm to assess infant's short term caloric compensation. At each studied age, the measure of caloric compensation required two visits at the laboratory on two non-consecutive days. On the first visit, the infants received a fixed amount of a food preload either low or high in energy density. The order of the two preloads was counterbalanced. After a delay (ranging from several hours in the 3-4 months old infants to 25 min in 10.5- and 14.5-month-old infants), the infants were served an ad libitum meal. Weight intakes (g) were assessed by weighing each bottle/bowl before and after consumption.

Eligibility Criteria

Age3 Months - 11 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Recruitment was conducted using leaflets distributed in health professionals' consulting rooms, an internal database (Chemosens Platform's PanelSens, CNIL n°1148039) and with the help of a recruitment agency.

You may qualify if:

  • no chronic health problem or food allergies
  • not having been fed with hydrolysate formula
  • gestational age ≥ 37 weeks
  • born weight ≥ 2.5kg
  • without having being tube fed at any moment

You may not qualify if:

  • infants from diabetic mothers
  • infants from mothers having celiac disease
  • infants from minor parents (\<18 years old) were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Birch, L.L. and M. Deysher, Conditioned and unconditioned caloric compensation: evidence for self regulation of food intake in young children. Learning and Motivation, 1985. 16: p. 341-355.

    BACKGROUND
  • Brugailleres P, Chabanet C, Issanchou S, Schwartz C. Caloric compensation ability around the age of 1 year: Interplay with the caregiver-infant mealtime interaction and infant appetitive traits. Appetite. 2019 Nov 1;142:104382. doi: 10.1016/j.appet.2019.104382. Epub 2019 Jul 23.

  • Brugailleres P, Issanchou S, Nicklaus S, Chabanet C, Schwartz C. Caloric compensation in infants: developmental changes around the age of 1 year and associations with anthropometric measurements up to 2 years. Am J Clin Nutr. 2019 May 1;109(5):1344-1352. doi: 10.1093/ajcn/nqy357.

MeSH Terms

Conditions

Self-ControlFeeding BehaviorInfant Behavior

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorBehavior, AnimalChild Behavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2018

First Posted

January 24, 2018

Study Start

June 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

January 25, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share