Obesity in ChildrenNCT02229552
Habituation to Food as a Risk Factor for Pediatric Obesity
A study testing Standardized Assessments in people with Obesity in Children, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The study is designed to assess habituation of behavioral responding for food as risk factors for increases in Standardized Body Mass Index (zBMI) over two years in non-overweight children. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity in Children
- What is being tested?
- Standardized Assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 8-12 years of age
- Participants will include children who are at the 50th BMI percentile and less than the 85th BMI percentile (BMI = kg/m2) at baseline. We will also include children who are below the 50th percentile, but have at least one biological parent with a current BMI ≥ 25 kg/m2.
Who cannot join
- Food allergies or special diets: Youth should have no dietary restrictions that could interfere with these experiments, including food allergies or religious or ethnic practices that limit food choice or medical conditions which alter nutritional status or intestinal absorption (e.g. inflammatory bowel disease).
- Activity restrictions: Children who have activity restrictions due to medical or physical problems, such as uncontrolled exercise induced asthma or a disability requiring wheelchair use will not participate.
- Psychopathology, medications or sickness: Children should have no psychopathology (e.g. childhood schizophrenia) or developmental disabilities that would limit participation. Children will also be excluded if they are taking medications that could affect their level of activity or appetite (e.g. methylphenidate).
- Moderate or greater liking of study foods. Children must report at least a moderate liking ( 3 or greater on a 5-point Likert-type scale) of the foods used in these studies and be willing to consume them.
Trial locations and contacts
1 site in 1 country.
About this study
The study is designed to assess habituation of behavioral responding for food as risk factors for increases in Standardized Body Mass Index (zBMI) over two years in non-overweight children.
Read the detailed description
Cross sectional data have shown slower habituation is related to greater energy intake, and habituation is slower for overweight/obese compared to leaner youth, but it is not known whether this is a result of being overweight, or whether slower habituation is a risk factor for weight gain. The goal of this application is to study individual differences in behavioral (responding for food) habituation as risk factors for alterations in zBMI and body fat over a two year period in 200, 8 to 12 year-old non-overweight children. This project will provide the first test of the hypothesis that slow habituation to food is a risk factor for increases in zBMI in non-overweight youth.
- Conditions
- Obesity in Children
- Being tested
- Standardized Assessments
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized AssessmentsOther
Children were asked to attend appointments without consuming study foods 24 hours previously, as habituation measurements are sensitive to recent consumption. Children were provided access to snack prior to completing questionnaires or cognitive assessments. Habituation to food, questionnaires and cognitive assessments were re-measured at 1-year and 2-year follow up.
| Study group | Role | What they receive |
|---|---|---|
| Baseline Cohort | Other | Children completed body weight and other measures at baseline, 1-year follow up and 2-year follow up measurement periods. Receives: Other: Standardized Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in zBMI
To assess the rate of habituation of behavioral responding to savory, sweet and salty foods as independent or interactive risk factors for zBMI trajectories, with the hypothesis that the rate of habituation of behavioral responding for food predicts zBMI trajectories over time, controlling for child gender, parental education, parental BMI, physical activity, ethnicity, the reinforcing value of food and eating in the absence of hunger.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startNov 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obesity in ChildrenStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Children completed measurements of body weight, habituation to food, questionnaires and cognitive assessments in a repeated assessment prospective study.
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonard Epstein, State University of New York at Buffalo
- Investigators
- Leonard Epstein, Ph.D., Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229552
- Sponsor's protocol ID
- 1102924-1-61250
- Status last verified
- Oct 2020
- First submitted
- 18 Jul 2014
- Last updated
- 26 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Epstein LH, Carr KA, O'Brien A, Paluch RA, Temple JL. High reinforcing value of food is related to slow habituation to food. Eat Behav. 2020 Aug;38:101414. doi: 10.1016/j.eatbeh.2020.101414. Epub 2020 Jul 29.
PubMed 32799072Epstein LH, Carr KA, Scheid JL, Gebre E, O'Brien A, Paluch RA, Temple JL. Taste and food reinforcement in non-overweight youth. Appetite. 2015 Aug;91:226-32. doi: 10.1016/j.appet.2015.04.050. Epub 2015 Apr 16.
PubMed 25891040Kong KL, Feda DM, Eiden RD, Epstein LH. Origins of food reinforcement in infants. Am J Clin Nutr. 2015 Mar;101(3):515-22. doi: 10.3945/ajcn.114.093237. Epub 2015 Jan 14.
PubMed 25733636
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Habituation to Food as a Risk Factor for Pediatric Obesity
- ClinicalTrials.gov ID
- NCT02229552
- Acronym / sponsor ID
- 1102924-1-61250
- Conditions
- Obesity in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 Sep 2014 (estimated)
- Results
- Posted 26 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to assess habituation of behavioral responding for food as risk factors for increases in Standardized Body Mass Index (zBMI) over two years in non-overweight children.
Detailed description
Cross sectional data have shown slower habituation is related to greater energy intake, and habituation is slower for overweight/obese compared to leaner youth, but it is not known whether this is a result of being overweight, or whether slower habituation is a risk factor for weight gain. The goal of this application is to study individual differences in behavioral (responding for food) habituation as risk factors for alterations in zBMI and body fat over a two year period in 200, 8 to 12 year-old non-overweight children. This project will provide the first test of the hypothesis that slow habituation to food is a risk factor for increases in zBMI in non-overweight youth.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Children completed measurements of body weight, habituation to food, questionnaires and cognitive assessments in a repeated assessment prospective study.
| Arm | Type | Receives |
|---|---|---|
| Baseline Cohort | Other | Other: Standardized AssessmentsChildren completed body weight and other measures at baseline, 1-year follow up and 2-year follow up measurement periods. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 8-12 years of age
- Participants will include children who are at the 50th BMI percentile and less than the 85th BMI percentile (BMI = kg/m2) at baseline. We will also include children who are below the 50th percentile, but have at least one biological parent with a current BMI ≥ 25 kg/m2.
Key exclusion criteria (4 listed)
- Food allergies or special diets: Youth should have no dietary restrictions that could interfere with these experiments, including food allergies or religious or ethnic practices that limit food choice or medical conditions which alter nutritional status or intestinal absorption (e.g. inflammatory bowel disease).
- Activity restrictions: Children who have activity restrictions due to medical or physical problems, such as uncontrolled exercise induced asthma or a disability requiring wheelchair use will not participate.
- Psychopathology, medications or sickness: Children should have no psychopathology (e.g. childhood schizophrenia) or developmental disabilities that would limit participation. Children will also be excluded if they are taking medications that could affect their level of activity or appetite (e.g. methylphenidate).
- Moderate or greater liking of study foods. Children must report at least a moderate liking ( 3 or greater on a 5-point Likert-type scale) of the foods used in these studies and be willing to consume them.
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 |
|---|---|---|
| Standardized AssessmentsChildren were asked to attend appointments without consuming study foods 24 hours previously, as habituation measurements are sensitive to recent consumption. Children were provided access to snack prior to completing questionnaires or cognitive assessments. Habituation to food, questionnaires and cognitive assessments were re-measured at 1-year and 2-year follow up. | Other | Baseline Cohort |
Primary outcome
Change in zBMI
Time frame: 2 years
To assess the rate of habituation of behavioral responding to savory, sweet and salty foods as independent or interactive risk factors for zBMI trajectories, with the hypothesis that the rate of habituation of behavioral responding for food predicts zBMI trajectories over time, controlling for child gender, parental education, parental BMI, physical activity, ethnicity, the reinforcing value of food and eating in the absence of hunger.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32799072Epstein LH, Carr KA, O'Brien A, Paluch RA, Temple JL. High reinforcing value of food is related to slow habituation to food. Eat Behav. 2020 Aug;38:101414. doi: 10.1016/j.eatbeh.2020.101414. Epub 2020 Jul 29.
- Derived from this study: PubMed 25891040Epstein LH, Carr KA, Scheid JL, Gebre E, O'Brien A, Paluch RA, Temple JL. Taste and food reinforcement in non-overweight youth. Appetite. 2015 Aug;91:226-32. doi: 10.1016/j.appet.2015.04.050. Epub 2015 Apr 16.
- Derived from this study: PubMed 25733636Kong KL, Feda DM, Eiden RD, Epstein LH. Origins of food reinforcement in infants. Am J Clin Nutr. 2015 Mar;101(3):515-22. doi: 10.3945/ajcn.114.093237. Epub 2015 Jan 14.
- UB Division of Behavioral Medicine WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Leonard Epstein, Ph.D. principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Assessments in people with Obesity in Children, run by State University of New York at Buffalo 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 2 inclusion and 4 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 26 Oct 2020. 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?
Yes. Results are posted in the registry (first posted 26 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 zBMI (time frame: 2 years). 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 NCT02229552, which also lists 3 linked publications.
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 26 Oct 2020.