Weight GainNCT01807572
Relation of Consummatory and Anticipatory Food Reward to Obesity
An observational study of Weight Gain and Food Habits, run by Oregon Research Institute at 1 site in United States.
Trial summary
Obesity is associated with increased risk for mortality, atherosclerotic cerebrovascular disease, coronary heart disease, colorectal cancer, hyperlipidemia, hypertension, gallbladder disease, and diabetes mellitus, resulting in over 111,000 deaths annually in the United States ). Read more about this study
- Who is it for?
- Ages 14 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Gain, Food Habits
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jul 2015
- 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 14 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants will be 140 lean adolescents at risk for obesity (by virtue of having two obese parents) and 40 lean adolescents with two lean parents. Participants will range in age from 14-16 and be recruited from high schools.
Who may be able to join
- We will require that adolescents have age- and sex- adjusted standardized body mass index (BMI) scores between the 25th and 75th percentile at baseline for inclusion.
- Low risk youth: Lean parents will have a BMI between 18 and 25.
- High risk youth: Obese parents will have a BMI value of greater than 30.
Who cannot join
- Students who report contraindicators of fMRI (e.g., metal implants, braces, or pregnancy).
- Current major psychiatric disorders (including substance use disorders, conduct disorder, oppositional defiant disorder, ADHD, major depression, bipolar disorder, panic disorder, agoraphobia, or generalized anxiety disorder)
- Current use of analgesics and other psychoactive drugs (e.g., cocaine)
- Serious medical complications (e.g., diabetes)
- Relevant food allergies
- Current smoking
- Current weight loss dieting
Trial locations and contacts
1 site in 1 country.
About this study
Obesity is associated with increased risk for mortality, atherosclerotic cerebrovascular disease, coronary heart disease, colorectal cancer, hyperlipidemia, hypertension, gallbladder disease, and diabetes mellitus, resulting in over 111,000 deaths annually in the United States ). In the US, 65% of adults are overweight or obese. Unfortunately, the treatment of choice for obesity (behavioral weight loss treatment) only results in a 10% reduction in body weight on average and most patients regain this weight within a few years. Further, most obesity prevention programs do not reduce risk for future weight gain. The limited success of treatment and prevention interventions may be due to an incomplete understanding of the processes that increase risk for obesity. Recent data suggest that obese adults show abnormalities in reward from food intake and anticipated food intake relative to lean adults, but the precise nature of these abnormalities is unclear and it has not been established whether these abnormalities predate obesity onset or are a consequence. It is vital to elucidate risk factors for obesity onset to advance understanding of etiological processes and determine the content of prevention and treatment programs.
The goals of this study are to (1) determine whether adolescents at high-risk for obesity, by virtue of having two obese parents, show abnormalities in reward from food intake (consummatory food reward) and anticipated reward from food intake (anticipatory food reward) compared to adolescents who are at low-risk for obesity, (2) determine whether abnormalities in consummatory and anticipatory food reward increase risk for weight gain and obesity onset, (3) examine moderators that may amplify the relations of consummatory and anticipatory food reward to unhealthy weight gain, and (4) examine changes in consummatory and anticipatory food reward in those participants who show obesity onset relative to those not showing obesity onset. Each of these goals is described in more detail below.
- Conditions
- Weight Gain, Food Habits
- Medical subject headings
- Weight Gain, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| obesity risk status | Lean adolescents at high-risk for obesity, by virtue of parental obesity, and lean adolescents at low-risk for obesity, by virtue of lean parents. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test whether high-risk youth show abnormalities in consummatory and anticipatory food reward relative to low-risk youth
Using fMRI to test whether high-risk youth for obesity show differential neural responses in the striatum, and oral somatosensory and gustatory related brain regions when anticipating and during intake of a palatable food, relative to youth at low risk for obesity.
Measured: up to 3 years
Secondary outcomes (1)
Test the hypothesis that individuals showing abnormalities in anticipatory and consummatory food reward are at increased risk for future weight gain and obesity onset over a 3-year follow-up
Determine whether those showing hyper-brain activation during anticipation and intake of a palatable food (via fMRI) gain more body weight over a three year period.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startJun 2009
- Primary completionMay 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Weight GainStudies 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
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Eric Stice, PhD, Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807572
- Sponsor's protocol ID
- DK080760-01
- Status last verified
- Sep 2015
- First submitted
- 7 Feb 2013
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Winter SR, Yokum S, Stice E, Osipowicz K, Lowe MR. Elevated reward response to receipt of palatable food predicts future weight variability in healthy-weight adolescents. Am J Clin Nutr. 2017 Apr;105(4):781-789. doi: 10.3945/ajcn.116.141143. Epub 2017 Feb 22.
PubMed 28228422Burger KS, Stice E. Elevated energy intake is correlated with hyperresponsivity in attentional, gustatory, and reward brain regions while anticipating palatable food receipt. Am J Clin Nutr. 2013 Jun;97(6):1188-94. doi: 10.3945/ajcn.112.055285. Epub 2013 Apr 17.
PubMed 23595877
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Consummatory and Anticipatory Food Reward to Obesity
- ClinicalTrials.gov ID
- NCT01807572
- Acronym / sponsor ID
- DK080760-01
- Conditions
- Weight Gain, Food Habits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2009
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 8 Mar 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.
Obesity is associated with increased risk for mortality, atherosclerotic cerebrovascular disease, coronary heart disease, colorectal cancer, hyperlipidemia, hypertension, gallbladder disease, and diabetes mellitus, resulting in over 111,000 deaths annually in the United States ). In the US, 65% of adults are overweight or obese. Unfortunately, the treatment of choice for obesity (behavioral weight loss treatment) only results in a 10% reduction in body weight on average and most patients regain this weight within a few years. Further, most obesity prevention programs do not reduce risk for future weight gain. The limited success of treatment and prevention interventions may be due to an incomplete understanding of the processes that increase risk for obesity. Recent data suggest that obese adults show abnormalities in reward from food intake and anticipated food intake relative to lean adults, but the precise nature of these abnormalities is unclear and it has not been established whether these abnormalities predate obesity onset or are a consequence. It is vital to elucidate risk factors for obesity onset to advance understanding of etiological processes and determine the content of prevention and treatment programs.
The goals of this study are to (1) determine whether adolescents at high-risk for obesity, by virtue of having two obese parents, show abnormalities in reward from food intake (consummatory food reward) and anticipated reward from food intake (anticipatory food reward) compared to adolescents who are at low-risk for obesity, (2) determine whether abnormalities in consummatory and anticipatory food reward increase risk for weight gain and obesity onset, (3) examine moderators that may amplify the relations of consummatory and anticipatory food reward to unhealthy weight gain, and (4) examine changes in consummatory and anticipatory food reward in those participants who show obesity onset relative to those not showing obesity onset. Each of these goals is described in more detail below.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obesity risk status | – | –Lean adolescents at high-risk for obesity, by virtue of parental obesity, and lean adolescents at low-risk for obesity, by virtue of lean parents. |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants will be 140 lean adolescents at risk for obesity (by virtue of having two obese parents) and 40 lean adolescents with two lean parents. Participants will range in age from 14-16 and be recruited from high schools.
Key inclusion criteria (3 listed)
- We will require that adolescents have age- and sex- adjusted standardized body mass index (BMI) scores between the 25th and 75th percentile at baseline for inclusion.
- Low risk youth: Lean parents will have a BMI between 18 and 25.
- High risk youth: Obese parents will have a BMI value of greater than 30.
Key exclusion criteria (7 listed)
- Students who report contraindicators of fMRI (e.g., metal implants, braces, or pregnancy).
- Current major psychiatric disorders (including substance use disorders, conduct disorder, oppositional defiant disorder, ADHD, major depression, bipolar disorder, panic disorder, agoraphobia, or generalized anxiety disorder)
- Current use of analgesics and other psychoactive drugs (e.g., cocaine)
- Serious medical complications (e.g., diabetes)
- Relevant 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
Test whether high-risk youth show abnormalities in consummatory and anticipatory food reward relative to low-risk youth
Time frame: up to 3 years
Using fMRI to test whether high-risk youth for obesity show differential neural responses in the striatum, and oral somatosensory and gustatory related brain regions when anticipating and during intake of a palatable food, relative to youth at low risk for obesity.
1 secondary outcome
Test the hypothesis that individuals showing abnormalities in anticipatory and consummatory food reward are at increased risk for future weight gain and obesity onset over a 3-year follow-up
Time frame: up to 3 years
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 1 Oct 2015.
- Derived from this study: PubMed 28228422Winter SR, Yokum S, Stice E, Osipowicz K, Lowe MR. Elevated reward response to receipt of palatable food predicts future weight variability in healthy-weight adolescents. Am J Clin Nutr. 2017 Apr;105(4):781-789. doi: 10.3945/ajcn.116.141143. Epub 2017 Feb 22.
- Derived from this study: PubMed 23595877Burger KS, Stice E. Elevated energy intake is correlated with hyperresponsivity in attentional, gustatory, and reward brain regions while anticipating palatable food receipt. Am J Clin Nutr. 2013 Jun;97(6):1188-94. doi: 10.3945/ajcn.112.055285. Epub 2013 Apr 17.
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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.
Eric Stice, PhD principal investigator
Oregon Research Institute
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 Weight Gain and Food Habits, run by Oregon Research Institute 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 3 inclusion and 7 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 1 Oct 2015. 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?
Test whether high-risk youth show abnormalities in consummatory and anticipatory food reward relative to low-risk youth (time frame: up to 3 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 NCT01807572, which also lists 2 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 1 Oct 2015.