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

C

Cary Savage, Ph.D.

Status

Completed

Conditions

Obesity

Treatments

Other: Assessments and Diet Intake
Other: Diet Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02031848
11123 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

137 patients

Sex

All

Ages

21 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

137 participants in 2 patient groups

Healthy Weight Control Group
Active Comparator group
Description:
Subjects will complete the Assessments, Diet Intake, and MRI portions of the study
Treatment:
Other: Assessments and Diet Intake
Dieting Group
Active Comparator group
Description:
Subjects will complete the Assessments, Diet Intake, and MRI portions of the study and will be given the weight loss and weight maintenance diets, and will attend weekly behavioral meetings
Treatment:
Other: Diet Intervention

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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