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

• Sponsor: The Miriam Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01218503
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), California Institute of Technology (Other)
• Enrollment: 90
• Locations: 2
• Arm: 1
• Duration (Months): 79
• Patients Per Site: 45
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Weight Loss; Weight Control	Behavioral: CHOICES - obese	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: N/A
• 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)
• Study Start Date: Mar 1, 2010
• Anticipated Primary Completion Date: Oct 1, 2016
• Anticipated Study Completion Date: Oct 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. fMRI [pre- and post-treatment in obese group, single time point for SWLM and NW]

Secondary Outcome Measures

1. Behavioral data [pre- and post-treatment of obese group, single time point for SWLM and NW]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Weight Control & Diabetes Research Center	Providence	Rhode Island	United States	02903
2	Weight Control & Diabetes Research Center	Providence	Rhode Island	United States	02903

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kathryn E. Demos, Assistant Professor (Research), The Miriam Hospital
• ClinicalTrials.gov Identifier: NCT01218503
• Other Study ID Numbers: BRAIN-T32; K01DK090445
• First Posted: Oct 11, 2010
• Last Update Posted: Jul 29, 2013
• Last Verified: Jul 1, 2013

• Additional relevant MeSH terms: Obesity; Body Weight; Weight Loss

Study Results

No Results Posted as of Jul 29, 2013