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

NCT01218503 | Unknown

• 2 other identifiers: BRAIN-T32K01DK090445
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity; Weight Loss; Weight Control

Outcome Measures

Primary Outcomes (1)

• fMRI

  pre- and post-treatment in obese group, single time point for SWLM and NW

Secondary Outcomes (1)

• Behavioral data

  pre- and post-treatment of obese group, single time point for SWLM and NW

Study Arms (1)

CHOICES - obese

EXPERIMENTAL

behavioral weight loss treatment - overweight/obese females

Behavioral: CHOICES - obese

Interventions

CHOICES - obese BEHAVIORAL

Standard group behavioral weight loss treatment

CHOICES - obese

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Weight Control & Diabetes Research Center

Providence, Rhode Island, 02903, United States

ACTIVE NOT RECRUITING

Weight Control & Diabetes Research Center

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Central Study Contacts

Kathryn E Demos, PhD

CONTACT

401-793-8939; kathryn_demos@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Research)

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 11, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 29, 2013

Record last verified: 2013-07

Locations

US (2)