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The Neural Correlates of Food Choice Decision-making in Obesity and Weight Loss (CHOICES)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by Kathryn E. Demos, The Miriam Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01218503
First Posted: October 11, 2010
Last Update Posted: July 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
California Institute of Technology
Information provided by (Responsible Party):
Kathryn E. Demos, The Miriam Hospital
  Purpose
This study is designed to determine whether obese, normal weight, and successful weight loss maintainers differ in their food choice decision-making and/or executive function, and whether participation in a behavioral weight loss program leads to neural and/or behavioral changes. The investigators will examine behavioral performance on several tasks involving decision-making and self-control in conjunction with brain imaging data acquired during a food-choice decision-making task. Participants enrolled in the behavioral weight loss program will also be assessed following the treatment.

Condition Intervention
Obesity Weight Loss Weight Control Behavioral: CHOICES - obese

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Neural Correlates of Food Choice Decision-making in Obesity and Weight Loss (CHOICES)

Resource links provided by NLM:


Further study details as provided by Kathryn E. Demos, The Miriam Hospital:

Primary Outcome Measures:
  • fMRI [ Time Frame: pre- and post-treatment in obese group, single time point for SWLM and NW ]

Secondary Outcome Measures:
  • Behavioral data [ Time Frame: pre- and post-treatment of obese group, single time point for SWLM and NW ]

Estimated Enrollment: 90
Study Start Date: March 2010
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CHOICES - obese
behavioral weight loss treatment - overweight/obese females
Behavioral: CHOICES - obese
Standard group behavioral weight loss treatment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women, ages 35-55, who are either currently obese (BMI = 30-40 kg/m2), always normal weight (lifetime BMI < 25, NW) or successful weight loss maintainers who have lost 10% of their body weight and maintained that loss for at least 1 year (lifetime maximum BMI = 30-40 kg/m2)

Exclusion Criteria:

  • weight loss medications, binge eating, standard MRI contraindications (e.g., metal implants, claustrophobia, pregnancy), left-handedness, food allergies, neurological or psychiatric conditions, including but not limited to schizophrenia, bipolar disorder, epilepsy, stroke and traumatic brain injury with loss of consciousness, and, among obese participants, inability to participate at two time points and lack of interest in participating in a behavioral weight loss trial
  • serious current physical disease (e.g., heart disease and cancer) for which physician supervision of diet and exercise prescription is needed, physical problems that limit the ability to exercise, participation in a weight loss program in the last 2 months and intention to become pregnant in the next 6 months
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218503


Contacts
Contact: Kathryn E Demos, PhD 401-793-8939 kathryn_demos@brown.edu

Locations
United States, Rhode Island
Weight Control & Diabetes Research Center Active, not recruiting
Providence, Rhode Island, United States, 02903
Weight Control & Diabetes Research Center Recruiting
Providence, Rhode Island, United States, 02903
Contact: Kathryn E Demos, PhD    401-793-8939    kathryn_demos@brown.edu   
Principal Investigator: Kathryn E Demos, PhD         
Sponsors and Collaborators
The Miriam Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
California Institute of Technology
  More Information

Responsible Party: Kathryn E. Demos, Assistant Professor (Research), The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01218503     History of Changes
Other Study ID Numbers: BRAIN-T32
K01DK090445 ( U.S. NIH Grant/Contract )
First Submitted: October 7, 2010
First Posted: October 11, 2010
Last Update Posted: July 29, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Obesity
Body Weight
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Signs and Symptoms
Body Weight Changes