Recruiting

Observational Study

Sponsor:

The Miriam Hospital

Code:

NCT01218503

Conditions

Obesity

Weight Loss

Weight Control

Eligibility Criteria

Sex: Female

Age: 35 - 55

Healthy Volunteers: Accepted

Interventions

CHOICES - obese

Study Details

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

Study ID

NCT01218503

Start date

Mar, 2010

Status verified date

Jul, 2013

Completion date

Oct, 2016

Anticipated

Primary completion date

Oct, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 35 - 55

Healthy Volunteers: Accepted

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

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: CHOICES - obese

behavioral weight loss treatment - overweight/obese females

Interventions

CHOICES - obese

Standard group behavioral weight loss treatment

Primary outcome measure

  • fMRI [ Time Frame: pre- and post-treatment in obese group, single time point for SWLM and NW ]

Central Contacts and Locations

Central contacts

Kathryn E Demos, PhD

401-793-8939kathryn_demos@brown.edu

Locations

Weight Control & Diabetes Research Center

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Kathryn E Demos, PhD

401-793-8939kathryn_demos@brown.edu

Principal Investigator:

Kathryn E Demos, PhD

More Information

Sponsor

The Miriam Hospital

Last update posted

Jul 29, 2013

Last verified

Jul, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2013-07-29.