Back to resultsThe Neural Correlates of Food Choice Decision-making in Obesity and Weight Loss (CHOICES)
Primary Purpose
Obesity, Weight Loss, Weight Control
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CHOICES - obese
Sponsored by
About this trial
This is an interventional basic science trial for Obesity
Eligibility 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
Sites / Locations
- Weight Control & Diabetes Research Center
- Weight Control & Diabetes Research CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CHOICES - obese
Arm Description
behavioral weight loss treatment - overweight/obese females
Outcomes
Primary Outcome Measures
fMRI
Secondary Outcome Measures
Behavioral data
Full Information
NCT ID
NCT01218503
First Posted
October 7, 2010
Last Updated
July 25, 2013
Sponsor
The Miriam Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), California Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT01218503
Brief Title
The Neural Correlates of Food Choice Decision-making in Obesity and Weight Loss
Acronym
CHOICES
Official Title
The Neural Correlates of Food Choice Decision-making in Obesity and Weight Loss (CHOICES)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), California Institute of Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss, Weight Control
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CHOICES - obese
Arm Type
Experimental
Arm Description
behavioral weight loss treatment - overweight/obese females
Intervention Type
Behavioral
Intervention Name(s)
CHOICES - obese
Intervention Description
Standard group behavioral weight loss treatment
Primary Outcome Measure Information:
Title
fMRI
Time Frame
pre- and post-treatment in obese group, single time point for SWLM and NW
Secondary Outcome Measure Information:
Title
Behavioral data
Time Frame
pre- and post-treatment of obese group, single time point for SWLM and NW
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathryn E Demos, PhD
Phone
401-793-8939
Email
kathryn_demos@brown.edu
Facility Information:
Facility Name
Weight Control & Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Weight Control & Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn E Demos, PhD
Phone
401-793-8939
Email
kathryn_demos@brown.edu
First Name & Middle Initial & Last Name & Degree
Kathryn E Demos, PhD
12. IPD Sharing Statement
Learn more about this trial
The Neural Correlates of Food Choice Decision-making in Obesity and Weight Loss
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