Keeping Weight Off: Brain Changes Associated With Healthy Behaviors

Obesity Clinical Trial

Official title:

Keeping Weight Off: Brain Changes Associated With Healthy Behaviors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189187
• Other study ID #: 5R34AT006963
• Status: Completed
• Phase: N/A
• First received: June 24, 2014
• Last updated: July 26, 2017
• Start date: December 2014
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this project is to characterize changes in emotion regulation pathways associated with healthy behaviors in people who have recently lost weight and are seeking to maintain weight loss over a 1-year period.

Description:

Unhealthy behaviors such as overeating and a sedentary lifestyle are largely responsible for overweight and obesity which substantially increase risk for chronic conditions such as heart disease, high blood pressure, stroke, diabetes, arthritis and certain cancers. The rapid rise in obesity threatens to reverse recent gains in life expectancy and account for a large percentage of premature deaths in the U.S. Although there is evidence for the short-term efficacy of a number of methods for initiating health behavior change to lose weight, these interventions have shown only limited ability to affect significant, long-term behavioral changes in the majority of adults. In part this may be because they fail to adequately address how psychological factors that lead to relapse to unhealthy behaviors and failure to maintain long-term behavior change.

The purpose of the study is to understand brain changes that accompany participation in programs that foster healthy behaviors in people seeking to maintain weight loss. We will use MRI scans to study brain function in men and women 25-60 years old who have lost weight in the last year without surgery. Participants will be assigned to one of two programs to help them maintain weight loss and will be compensated for their time. Our goal is to gain a better understanding of the brain changes that lead to long-term success in keeping weight off, in the hope that this knowledge will assist in the development of improved treatments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

• 25 to 60 years old

• Healthy individuals who have intentionally lost at least 5% of their body weight over the past year

• BMI >20.5 kg/m2 at study entry and >25 in past 2 years

Exclusion Criteria:

• Weight-loss surgery or medications

• Serious Psychiatric or medical conditions

• Substance abuse

• Ineligible for MRI

• Pregnant

• Eating disorder

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Mindfulness

• Psychoeducation

Locations

Country	Name	City	State
United States	Umass Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional connectivity on fMRI	Functional Magnetic Resonance Imaging (fMRI)	8 weeks
Secondary	Association of functional connectivity change with changes in depression symptoms	Center for Epidemiological Studies-Depression Scale (CES-D)	6 months
Secondary	Association of functional connectivity with maintenance of weight loss	BMI	6 months