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

Obesity Clinical Trial

— CHOICES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01218503
• Other study ID #: BRAIN-T32
• Secondary ID: K01DK090445
• Status: Recruiting
• Phase: N/A
• First received: October 7, 2010
• Last updated: July 25, 2013
• Start date: March 2010
• Est. completion date: October 2016

Study information

• Verified date: July 2013
• Source: The Miriam Hospital
• Contact: Kathryn E Demos, PhD
• Phone: 401-793-8939
• Email: kathryn_demos[@]brown.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 55 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Control
• Weight Loss

Intervention

Behavioral:
• CHOICES - obese
Standard group behavioral weight loss treatment

Locations

Country	Name	City	State
United States	Weight Control & Diabetes Research Center	Providence	Rhode Island
United States	Weight Control & Diabetes Research Center	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
The Miriam Hospital	California Institute of Technology, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI		pre- and post-treatment in obese group, single time point for SWLM and NW	No
Secondary	Behavioral data		pre- and post-treatment of obese group, single time point for SWLM and NW	No