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

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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Weight Loss; Weight Control
• Intervention / Treatment: Behavioral: CHOICES - obese

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathryn E Demos, PhD; Phone Number: 401-793-8939; Email: kathryn_demos@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Active, not recruiting
      • Weight Control & Diabetes Research Center
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Weight Control & Diabetes Research Center
      • Contact: Kathryn E Demos, PhD; Phone Number: 401-793-8939; Email: kathryn_demos@brown.edu
      • Principal Investigator: Kathryn E Demos, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHOICES - obese; behavioral weight loss treatment - overweight/obese females	Behavioral: CHOICES - obese; Standard group behavioral weight loss treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
fMRI	pre- and post-treatment in obese group, single time point for SWLM and NW

Secondary Outcome Measures

Outcome Measure	Time Frame
Behavioral data	pre- and post-treatment of obese group, single time point for SWLM and NW

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); California Institute of Technology

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: October 7, 2010
• First Submitted That Met QC Criteria: October 8, 2010
• First Posted (Estimate): October 11, 2010

Study Record Updates

• Last Update Posted (Estimate): July 29, 2013
• Last Update Submitted That Met QC Criteria: July 25, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight Changes; Obesity; Weight Loss; Body Weight
• Other Study ID Numbers: BRAIN-T32; K01DK090445 (U.S. NIH Grant/Contract)