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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by The Miriam Hospital
Sponsor:
Collaborators:
California Institute of Technology
Information provided by (Responsible Party):
Kathryn E. Demos, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01218503
First received: October 7, 2010
Last updated: July 25, 2013
Last verified: July 2013
  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: 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 The Miriam Hospital:

Primary Outcome Measures:
  • fMRI [ Time Frame: pre- and post-treatment in obese group, single time point for SWLM and NW ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Behavioral data [ Time Frame: pre- and post-treatment of obese group, single time point for SWLM and NW ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   35 Years to 55 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
California Institute of Technology
  More Information

No publications provided

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
Study First Received: October 7, 2010
Last Updated: July 25, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 27, 2014