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OpenTrials
Completed

NCT Number: NCT02031848

Brain Function Predictors And Outcome Of Weight Loss And Weight Loss Maintenance

By doing this study, researchers hope to learn whether a person's motivation for food is different after he or she loses weight, and if imaging techniques such as fMRI can be used to predict whether the person will maintain that weight loss over time.

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Key information

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center, Kansas City, Kansas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI equal to or greater than 30 kg/m2 or 18 to 24.9
  • declaration they do not have plans to move out of the Greater Kansas City area for at least 1 year
  • willingness to be randomized
  • Individuals undergoing weight loss will have to present written approval from a licensed physician that they are healthy enough to participate in a program of moderate diet restriction and moderate physical activity.

Exclusion criteria

  • Participation in a research project involving weight loss or PA in the previous 6 months, as these proximal experiences may impact the results of this study.
  • Subjects who smoke
  • Subjects who use special diets (i.e. vegetarian, Adkins, etc.), use medications that affect metabolism (i.e. thyroid, beta blockers), use medications that affect appetite (i.e. Meridia) or cannot exercise (i.e. walk).
  • Exhibit signs of eating disorders, restraint, depression
  • Participant has any metabolic disease that would affect energy balance (e.g. diabetes mellitus or hypothyroidism).
  • Individuals who report being pregnant during the previous 6 months, are lactating, or planned pregnancy within 12 months
  • Individuals who are not weight stable (± 4.5kg) within the previous 3 months or have more than 500 kcal/wk of planned physical activity
  • Serious medical risk such as type 1 diabetes, cancer, recent cardiac event (i.e. heart attack, angioplasty, etc.)

Treatment and study plan

Diet intervention

Other

Assessments and Diet Intake

Other

Primary outcomes

  1. Differences in brain activation to visual food cues

    Time frame: Change from Baseline to 3 Months

    differences will be measured by scanning subjects with fMRI and measuring changes in different regions of the brain.

Sponsors and collaborators

Lead sponsor

Cary Savage, Ph.D.

Other

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jan 9, 2014
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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