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ObesityNCT02084836

Relation of Consummatory & Anticipatory Food Reward to Obesity

An observational study of Obesity, run by Oregon Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 (Calle et al., 1999; Flegal et al.… Read more about this study

Who is it for?
Ages 14 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Functional Magnetic Resonance Imaging
How many people
162 participants
Where
1 siteUnited States
Study dates
Jun 2009to Jul 2014
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 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: 162 lean adolescents between 14-17 years old with BMIs between the 25th and 75th percentile at baseline

Who may be able to join

  • Between 14-17 years old
  • BMI between 25th and 75th percentile

Who cannot join

  • Contraindicators of functional magnetic resonance imaging (fMRI): metal implants, braces, pregnancy
  • Symptoms of major psychiatric disorders (substance use disorders, conduct disorder, attention deficit hyperactive disorder, major depression, bipolar disorder, panic disorder, agoraphobia, generalized anxiety disorder) binge eating
  • Current use of pyschoactive drugs
  • Serious medical conditions (diabetes, brain injury)
  • Current smoking
  • Relevant food allergies
  • Current weight loss dieting

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oregon Research Institute

    Eugene, Oregon, 97403

Other trials in United States

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 (Calle et al., 1999; Flegal et al., 2005). In the US, 65% of adults are overweight or obese (Hedley et al., 2004). 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 (Jeffery et al., 2000). Further, most obesity prevention programs do not reduce risk for future weight gain (Stice, Shaw, \& Marti, 2006). 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.

Conditions
Obesity
Being tested
Functional Magnetic Resonance Imaging
Keywords
fMRI obesity adolescents
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional Magnetic Resonance ImagingOther

Study groups in NCT02084836
Study groupRoleWhat they receive
Lean adolescentsNot described
Receives: Other: Functional Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. increases in BMI

    To determine whether abnormalities in consummatory and anticipatory food reward increase risk for weight gain and obesity onset.

    Measured: 1, 2, and 3 years

Secondary outcomes (1)

  1. (anticipated) reward from food intake

    To 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.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2014 (estimated)
  2. Study startJun 2009
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02084836
Sponsor's protocol ID
DK080760
Other IDs
R01DK080760
Status last verified
Nov 2017
First submitted
10 Mar 2014
Last updated
2 Dec 2017
Results posted
No
Data monitoring committee
No

Publications

  • Stice E, Yokum S. Brain reward region responsivity of adolescents with and without parental substance use disorders. Psychol Addict Behav. 2014 Sep;28(3):805-15. doi: 10.1037/a0034460. Epub 2013 Oct 14.

    PubMed 24128289

  • Burger 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

  • Stice E, Yokum S, Burger KS. Elevated reward region responsivity predicts future substance use onset but not overweight/obesity onset. Biol Psychiatry. 2013 May 1;73(9):869-76. doi: 10.1016/j.biopsych.2012.11.019. Epub 2013 Jan 8.

    PubMed 23312561

  • Stice E, Burger K, Yokum S. Caloric deprivation increases responsivity of attention and reward brain regions to intake, anticipated intake, and images of palatable foods. Neuroimage. 2013 Feb 15;67:322-30. doi: 10.1016/j.neuroimage.2012.11.028. Epub 2012 Nov 28.

    PubMed 23201365

  • Stice E, Yokum S, Burger K, Epstein L, Smolen A. Multilocus genetic composite reflecting dopamine signaling capacity predicts reward circuitry responsivity. J Neurosci. 2012 Jul 18;32(29):10093-100. doi: 10.1523/JNEUROSCI.1506-12.2012.

    PubMed 22815523

  • Burger KS, Stice E. Frequent ice cream consumption is associated with reduced striatal response to receipt of an ice cream-based milkshake. Am J Clin Nutr. 2012 Apr;95(4):810-7. doi: 10.3945/ajcn.111.027003. Epub 2012 Feb 15.

    PubMed 22338036

  • Stice E, Yokum S, Burger KS, Epstein LH, Small DM. Youth at risk for obesity show greater activation of striatal and somatosensory regions to food. J Neurosci. 2011 Mar 23;31(12):4360-6. doi: 10.1523/JNEUROSCI.6604-10.2011.

    PubMed 21430137

  • Yokum S, Bohon C, Berkman E, Stice E. Test-retest reliability of functional MRI food receipt, anticipated receipt, and picture tasks. Am J Clin Nutr. 2021 Aug 2;114(2):764-779. doi: 10.1093/ajcn/nqab096.

    PubMed 33851199

  • Hume DJ, Yokum S, Stice E. Low energy intake plus low energy expenditure (low energy flux), not energy surfeit, predicts future body fat gain. Am J Clin Nutr. 2016 Jun;103(6):1389-96. doi: 10.3945/ajcn.115.127753. Epub 2016 May 11.

    PubMed 27169833

  • Stice E, Palmrose CA, Burger KS. Elevated BMI and Male Sex Are Associated with Greater Underreporting of Caloric Intake as Assessed by Doubly Labeled Water. J Nutr. 2015 Oct;145(10):2412-8. doi: 10.3945/jn.115.216366. Epub 2015 Sep 2.

    PubMed 26338886

  • Stice E, Durant S. Elevated objectively measured but not self-reported energy intake predicts future weight gain in adolescents. Appetite. 2014 Oct;81:84-8. doi: 10.1016/j.appet.2014.06.012. Epub 2014 Jun 12.

    PubMed 24930597

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, 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 2 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 2 Dec 2017. 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?

increases in BMI (time frame: 1, 2, and 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 NCT02084836, which also lists 11 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 2 Dec 2017.

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