ObesityNCT02928874
Eating Phenotypes for Childhood Obesity in the Context of Familial Obesity Risk
A study testing % COMPX (low ED vs. high ED preload) and EAH (low ED vs. high ED snacks) in people with Obesity, run by University of Pennsylvania at 1 site in United States.
Trial summary
Using an integrated approach, this study examines multiple eating traits concurrently under states of hunger and satiety. It examines the impact of short-term appetite and intake regulation on longer-term energy intake control and weight development in a cohort of ethnically diverse normal-weight and obese boys and… Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- % COMPX (low ED vs. high ED preload) and EAH (low ED vs. high ED snacks)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 30 Aug 2019
- 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 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 7-9 years of age
- Normal-weight or overweight/obese who are at low risk or high risk for obesity based on maternal BMI
- Like most foods served during the study
- Be regular breakfast eaters
Who cannot join
- Have serious medical conditions known to affect food intake or body weight
- Have any developmental, medical, or psychiatric conditions that might impact study compliance
- Have a learning disability or poor reading ability/comprehension
- Have visual or auditory impairment
- Are taking medications associated with developmental, medical, or psychiatric disorders or medications known to affect appetite, food intake or body weight
- Are underweight
Show all 10Show fewer
- Have food allergies related to the foods served in the study or are lactose intolerant
- Do not regularly eat breakfast
- Do not like or cannot eat foods served during experimental meal or are unable to finish compulsory preload
- Mothers who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Using an integrated approach, this study examines multiple eating traits concurrently under states of hunger and satiety. It examines the impact of short-term appetite and intake regulation on longer-term energy intake control and weight development in a cohort of ethnically diverse normal-weight and obese boys and girls with different familial predispositions to obesity.
- Conditions
- Obesity
- Being tested
- % COMPX (low ED vs. high ED preload), EAH (low ED vs. high ED snacks)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
% COMPX (low ED vs. high ED preload)Behavioural
EAH (low ED vs. high ED snacks)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Caloric compensation | Experimental | Twenty-five minutes before breakfast, participants will be asked to consume in full one of two oatmeal preloads that will vary in ED. The order of preload conditions will be randomized across groups of children participating in the visits. Receives: Behavioral: % COMPX (low ED vs. high ED preload) |
| Eating in the absence of hunger (EAH) | Experimental | During both study visits, children's EAH will be assessed after lunch and again after dinner. The order of presenting the low and high ED snacks will be counterbalanced across meals. Receives: Behavioral: EAH (low ED vs. high ED snacks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent caloric compensation index (%COMPX)
Measured: Baseline
Appetite ratings assessed via Visual Analog Scales
Appetite ratings include self-reported perceived hunger, desire to eat, prospective consumption, and fullness.
Measured: Baseline
Total energy intake per day (number of calories consumed over 24-hours)
Number of calories consumed over 24-hours assessed via measured food intake in the laboratory and via parent-reported food intake at home.
Measured: Baseline
BMI z-score
Measured: Change from baseline BMI z-score at 1-year follow-up
Waist circumference (cm)
Measured: Change from baseline waist circumference at 1-year follow-up
Percentage body fat
Measured: Change from baseline percentage body fat at 1-year follow-up
Secondary outcomes (2)
Eating in the absence of hunger (kcal)
Measured: Baseline (number of calories consumed from snacks)
Home food environment
Measured: Baseline home food environment assessed using the Home Food Inventory
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startSep 2014
- Primary completion30 Aug 2018
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanja Kral, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928874
- Sponsor's protocol ID
- 820661
- Status last verified
- Oct 2019
- First submitted
- 4 Oct 2016
- Last updated
- 16 Oct 2019
- Results posted
- No
Publications
Kral TVE, Moore RH, Chittams J, O'Malley L, Jones E, Quinn RJ, Fisher JO. Caloric compensation and appetite control in children of different weight status and predisposition to obesity. Appetite. 2020 Aug 1;151:104701. doi: 10.1016/j.appet.2020.104701. Epub 2020 Apr 11.
PubMed 32289325
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Phenotypes for Childhood Obesity in the Context of Familial Obesity Risk
- ClinicalTrials.gov ID
- NCT02928874
- Acronym / sponsor ID
- 820661
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 10 Oct 2016 (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.
Using an integrated approach, this study examines multiple eating traits concurrently under states of hunger and satiety. It examines the impact of short-term appetite and intake regulation on longer-term energy intake control and weight development in a cohort of ethnically diverse normal-weight and obese boys and girls with different familial predispositions to obesity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caloric compensation | Experimental | Behavioral: % COMPX (low ED vs. high ED preload)Twenty-five minutes before breakfast, participants will be asked to consume in full one of two oatmeal preloads that will vary in ED. The order of preload conditions will be randomized across groups of children participating in the visits. |
| Eating in the absence of hunger (EAH) | Experimental | Behavioral: EAH (low ED vs. high ED snacks)During both study visits, children's EAH will be assessed after lunch and again after dinner. The order of presenting the low and high ED snacks will be counterbalanced across meals. |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 7-9 years of age
- Normal-weight or overweight/obese who are at low risk or high risk for obesity based on maternal BMI
- Like most foods served during the study
- Be regular breakfast eaters
Key exclusion criteria (10 listed)
- Have serious medical conditions known to affect food intake or body weight
- Have any developmental, medical, or psychiatric conditions that might impact study compliance
- Have a learning disability or poor reading ability/comprehension
- Have visual or auditory impairment
- Are taking medications associated with developmental, medical, or psychiatric disorders or medications known to affect appetite, food intake or body weight
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 |
|---|---|---|
| % COMPX (low ED vs. high ED preload) | Behavioural | Caloric compensation |
| EAH (low ED vs. high ED snacks) | Behavioural | Eating in the absence of hunger (EAH) |
Primary outcome
Percent caloric compensation index (%COMPX)
Time frame: Baseline
Appetite ratings assessed via Visual Analog Scales
Time frame: Baseline
Appetite ratings include self-reported perceived hunger, desire to eat, prospective consumption, and fullness.
Total energy intake per day (number of calories consumed over 24-hours)
Time frame: Baseline
Number of calories consumed over 24-hours assessed via measured food intake in the laboratory and via parent-reported food intake at home.
BMI z-score
Time frame: Change from baseline BMI z-score at 1-year follow-up
Waist circumference (cm)
Time frame: Change from baseline waist circumference at 1-year follow-up
Percentage body fat
Time frame: Change from baseline percentage body fat at 1-year follow-up
2 secondary outcomes
Eating in the absence of hunger (kcal)
Time frame: Baseline (number of calories consumed from snacks)
Home food environment
Time frame: Baseline home food environment assessed using the Home Food Inventory
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 16 Oct 2019.
- Derived from this study: PubMed 32289325Kral TVE, Moore RH, Chittams J, O'Malley L, Jones E, Quinn RJ, Fisher JO. Caloric compensation and appetite control in children of different weight status and predisposition to obesity. Appetite. 2020 Aug 1;151:104701. doi: 10.1016/j.appet.2020.104701. Epub 2020 Apr 11.
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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.
Tanja Kral, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing % COMPX (low ED vs. high ED preload) and EAH (low ED vs. high ED snacks) in people with Obesity, run by University of Pennsylvania at 1 site in United States.
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 4 inclusion and 10 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 16 Oct 2019. 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 United States. 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?
Percent caloric compensation index (%COMPX) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02928874, which also lists 1 linked publication.
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 16 Oct 2019.