NCT02084836

Brief 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., 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

5.1 years

First QC Date

March 10, 2014

Last Update Submit

November 29, 2017

Conditions

Keywords

fMRI obesity adolescents

Outcome Measures

Primary Outcomes (1)

  • increases in BMI

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

    1, 2, and 3 years

Secondary Outcomes (1)

  • (anticipated) reward from food intake

    baseline

Other Outcomes (1)

  • Changes in neural response to (anticipated) reward from food intake

    baseline, 2, and 3 year

Study Arms (1)

Lean adolescents

Other: Functional Magnetic Resonance Imaging

Interventions

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Related Publications (11)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eric Stice, Ph.D.

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 12, 2014

Study Start

June 1, 2009

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

December 2, 2017

Record last verified: 2017-11

Locations