ObesityNCT02166892
Specially Designed Eating Plates Effects on Food Intake in Normal Weight and Overweight Children
A study testing Specially designed plates in people with Obesity, run by Dan Nemet, MD at 1 site in Israel.
Trial summary
Previous studies demonstrated that children served themselves more food when using larger plates and bowels. The purpose of this study is to evaluate if self-served portions and caloric intake in normal weight and overweight children will be influenced by a specially designed eating plates compared to similar size… Read more about this study
- Who is it for?
- Ages 4 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Specially designed plates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2014to 1 Dec 2017
- Phase
- Interventional
- 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 4 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Over weight / obese children
- Normal weight children
Who cannot join
- Organic disease that cause obesity
- Underweight children (BMI percentiles < 5)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Specially Designed Eating Plates on Self-served Portions and Caloric Intake in Normal Weight and Overweight Children
Previous studies demonstrated that children served themselves more food when using larger plates and bowels. The purpose of this study is to evaluate if self-served portions and caloric intake in normal weight and overweight children will be influenced by a specially designed eating plates compared to similar size normal plates.
Read the detailed description
40 normal weight and 40 overweight kindergarden and elementary school children will participate in this study.
Anthropometric measurements: weight, height, BMI and BMI percentiles will be measured and calculated for each participant.
The participants will take part in two non-exercise activities at the 'sport and health center for children and adolescence'. At the end of each activity, a lunch buffet that contains all food ingredients will be served. During one meeting the children will be handed a regular plate and at the second meeting they will be handed a specially designed plate (with marking of the recommended meal composition and portion).
The amount and composition of food on the plates will be assessed by weighing and photography before and after eating and analysed to report macronutrient consumption by a dietitian. The meetings for normal weight children will be separated from the overweight children.
- Conditions
- Obesity
- Being tested
- Specially designed plates
- Keywords
- Childhood obesity, Plate, Food consumption
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specially designed platesOther
| Study group | Role | What they receive |
|---|---|---|
| Normal weight | Active comparator | Normal weight children will be served food in two different occasions using two sets of plates (same size). One set will be plane and the second is a specially designed plate that demonstrate the recommended food consumption and portion. Receives: Other: Specially designed plates |
| Overweight children | Active comparator | Overweight children will be served food in two different occasions using two sets of plates (same size). One set will be plane and the second is a specially designed plate that demonstrate the recommended food consumption and portion. Receives: Other: Specially designed plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caloric intake
The amount of food and drink consumed by the children will be evaluated.
Measured: Up to 1 hour after food serving
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study start1 Jul 2014
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dan Nemet, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dan Nemet, MD, Meir Medical Center
- Investigators
- Dan Nemet, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166892
- Sponsor's protocol ID
- MeirMc0042-14CTIL
- Status last verified
- Mar 2018
- First submitted
- 9 Jun 2014
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Specially Designed Eating Plates on Self-served Portions and Caloric Intake in Normal Weight and Overweight Children
- ClinicalTrials.gov ID
- NCT02166892
- Acronym / sponsor ID
- MeirMc0042-14CTIL
- Conditions
- Obesity
- Keywords
- Childhood obesity, Plate, Food consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Dan Nemet, MDUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 18 Jun 2014 (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.
Previous studies demonstrated that children served themselves more food when using larger plates and bowels. The purpose of this study is to evaluate if self-served portions and caloric intake in normal weight and overweight children will be influenced by a specially designed eating plates compared to similar size normal plates.
Detailed description
40 normal weight and 40 overweight kindergarden and elementary school children will participate in this study.
Anthropometric measurements: weight, height, BMI and BMI percentiles will be measured and calculated for each participant.
The participants will take part in two non-exercise activities at the 'sport and health center for children and adolescence'. At the end of each activity, a lunch buffet that contains all food ingredients will be served. During one meeting the children will be handed a regular plate and at the second meeting they will be handed a specially designed plate (with marking of the recommended meal composition and portion).
The amount and composition of food on the plates will be assessed by weighing and photography before and after eating and analysed to report macronutrient consumption by a dietitian. The meetings for normal weight children will be separated from the overweight children.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal weight | Active comparator | Other: Specially designed platesNormal weight children will be served food in two different occasions using two sets of plates (same size). One set will be plane and the second is a specially designed plate that demonstrate the recommended food consumption and portion. |
| Overweight children | Active comparator | Other: Specially designed platesOverweight children will be served food in two different occasions using two sets of plates (same size). One set will be plane and the second is a specially designed plate that demonstrate the recommended food consumption and portion. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Over weight / obese children
- Normal weight children
Key exclusion criteria (2 listed)
- Organic disease that cause obesity
- Underweight children (BMI percentiles < 5)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specially designed plates | Other | Normal weight, Overweight children |
Primary outcome
Caloric intake
Time frame: Up to 1 hour after food serving
The amount of food and drink consumed by the children will be evaluated.
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 22 Mar 2018.
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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.
Dan Nemet, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specially designed plates in people with Obesity, run by Dan Nemet, MD at 1 site in Israel.
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 2 inclusion and 2 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 22 Mar 2018. 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 Israel. 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?
Caloric intake (time frame: Up to 1 hour after food serving). 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 22 Mar 2018.