HealthyNCT01982279
Longitudinal Measurement of Caloric Compensation and Eating in the Absence of Hunger in French Preschool Children
An observational study of Healthy, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial summary
Objectives: The aims were to measure one year change in caloric compensation (CC) and eating in the absence of hunger (EAH) in 3 to 6 year-old French children in their regular eating context and to link these change with individual characteristics (adiposity, age, gender) and maternal feeding practices. Read more about this study
- Who is it for?
- Ages 2 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 236 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The population was composed of 236 children at inclusion. Among them, 98 participated in the three time of measurements of caloric compensation or eating in the absence of hunger.
Who may be able to join
- To be registered to the school canteen, to provide parental approval at inclusion and at the FU15M
Who cannot join
- Chronic disease or food allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One Year Change in Caloric Compensation and Eating in the Absence of Hunger in French Preschool Children
Objectives: The aims were to measure one year change in caloric compensation (CC) and eating in the absence of hunger (EAH) in 3 to 6 year-old French children in their regular eating context and to link these change with individual characteristics (adiposity, age, gender) and maternal feeding practices.
Three series of measurements of caloric compensation (CC) and eating in the absence of hunger (EAH) were conducted: at baseline, and 3 (FU3M) and 15 (FU15M) months later. Each serie of measurement was composed of three consecutive weeks an identical lunch was served in four preschool canteens reaching 236 children. The first lunch was a control session. For the CC situation (week 2), thirty minutes before the lunch children were offered a preload (137 kcal). For the EAH situation (week 3), ten minutes after lunch children were exposed to palatable foods (430 kcal). Food intake was measured at the individual level. Maternal eating behaviour and feeding practices were measured by questionnaires. Child's height and weight were measured by a medical doctor.
- Conditions
- Healthy
- Keywords
- Caloric compensation, Eating in the absence of hunger, Preschool children, Maternal feeding practices, Maternal eating behavior, one year, children
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in caloric compensation in 15 months
To evaluate the change in caloric compensation across time, caloric compensation was measured at baseline, 3 and 15 months after baseline, in the same conditions. At each time point to assess caloric compensation, children were offered a chocolate bun 30 minutes before the lunch. The food intake at lunch was recorded. We calculated if children compensated the chocolate bun, by comparing energy intake at this lunch with energy intake from a control lunch which took place one week before.
Measured: one week
Control measurement of energy intake at baseline
We conducted a control lunch and recorded food intake of each child. This measurement was conducted a week before measuring caloric compensation.
Measured: One week
Change in eating in the absence of hunger in 15 months
In order to evaluate the change in eating in the absence of hunger across time, a measurement was conducted at baseline, 3 months and 15 months after baseline. To collect the measurement of eating in the absence of hunger, we offered palatable foods to children 10 minutes after their lunch. We recorded the energy intake from these post-meal foods. At each time point, this measurement was conducted one week after the measurement of caloric compensation.
Measured: one week.
Control measurement of energy intake three months after baseline
We conducted a control lunch and recorded food intake of each child. This measurement was conducted a week before measuring caloric compensation.
Measured: One week
Control measurement of energy intake fifteen months after baseline
We conducted a control lunch and recorded food intake of each child. This measurement was conducted a week before measuring caloric compensation.
Measured: One week
Secondary outcomes (1)
Maternal feeding practices and eating behavior
Using a validated questionnaire, we collected information about maternal feeding practices (Comprehensive Feeding Practices Questionnaire, Musher-Eizenman \& Holub, 2007) and eating behaviour (Dutch Eating Behaviour Questionnaire, Van Strien, 1986).
Measured: one month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startFeb 2011
- Primary completionMar 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor
- Investigators
- Nicklaus Sophie, phD, Principal investigator, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982279
- Sponsor's protocol ID
- HabEat WP31 Follow up
- Other IDs
- INRA WP31 FU, WP31.FU. INRA
- Status last verified
- Nov 2013
- First submitted
- 30 Oct 2013
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Change in Caloric Compensation and Eating in the Absence of Hunger in French Preschool Children
- ClinicalTrials.gov ID
- NCT01982279
- Acronym / sponsor ID
- HabEat WP31 Follow up
- Conditions
- Healthy
- Keywords
- Caloric compensation, Eating in the absence of hunger, Preschool children, Maternal feeding practices, Maternal eating behavior, one year, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- European Union
- Study start
- Feb 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: The aims were to measure one year change in caloric compensation (CC) and eating in the absence of hunger (EAH) in 3 to 6 year-old French children in their regular eating context and to link these change with individual characteristics (adiposity, age, gender) and maternal feeding practices.
Three series of measurements of caloric compensation (CC) and eating in the absence of hunger (EAH) were conducted: at baseline, and 3 (FU3M) and 15 (FU15M) months later. Each serie of measurement was composed of three consecutive weeks an identical lunch was served in four preschool canteens reaching 236 children. The first lunch was a control session. For the CC situation (week 2), thirty minutes before the lunch children were offered a preload (137 kcal). For the EAH situation (week 3), ten minutes after lunch children were exposed to palatable foods (430 kcal). Food intake was measured at the individual level. Maternal eating behaviour and feeding practices were measured by questionnaires. Child's height and weight were measured by a medical doctor.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The population was composed of 236 children at inclusion. Among them, 98 participated in the three time of measurements of caloric compensation or eating in the absence of hunger.
Key inclusion criteria (1 listed)
- To be registered to the school canteen, to provide parental approval at inclusion and at the FU15M
Key exclusion criteria (1 listed)
- Chronic disease or food allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in caloric compensation in 15 months
Time frame: one week
To evaluate the change in caloric compensation across time, caloric compensation was measured at baseline, 3 and 15 months after baseline, in the same conditions. At each time point to assess caloric compensation, children were offered a chocolate bun 30 minutes before the lunch. The food intake at lunch was recorded. We calculated if children compensated the chocolate bun, by comparing energy intake at this lunch with energy intake from a control lunch which took place one week before.
Control measurement of energy intake at baseline
Time frame: One week
We conducted a control lunch and recorded food intake of each child. This measurement was conducted a week before measuring caloric compensation.
Change in eating in the absence of hunger in 15 months
Time frame: one week.
In order to evaluate the change in eating in the absence of hunger across time, a measurement was conducted at baseline, 3 months and 15 months after baseline. To collect the measurement of eating in the absence of hunger, we offered palatable foods to children 10 minutes after their lunch. We recorded the energy intake from these post-meal foods. At each time point, this measurement was conducted one week after the measurement of caloric compensation.
Control measurement of energy intake three months after baseline
Time frame: One week
We conducted a control lunch and recorded food intake of each child. This measurement was conducted a week before measuring caloric compensation.
Control measurement of energy intake fifteen months after baseline
Time frame: One week
We conducted a control lunch and recorded food intake of each child. This measurement was conducted a week before measuring caloric compensation.
1 secondary outcome
Maternal feeding practices and eating behavior
Time frame: one month after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
- Web site for the main research project funded by the European UnionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicklaus Sophie, phD principal investigator
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in caloric compensation in 15 months (time frame: one week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.