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Keeping Weight Off: Brain Changes Associated With Healthy Behaviors

Keeping Weight Off: Brain Changes Associated With Healthy Behaviors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02189187
Enrollment
55
Registered
2014-07-14
Start date
2014-12-31
Completion date
2017-07-31
Last updated
2017-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Weight Loss, Body Weight Changes, Body Weight, Magnetic Resonance Imaging, Emotions, Emotion regulation, Health Behavior, Eating behavior

Brief 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.

Detailed 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.

Interventions

BEHAVIORALMindfulness
BEHAVIORALPsychoeducation

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Functional connectivity on fMRI8 weeksFunctional Magnetic Resonance Imaging (fMRI)

Secondary

MeasureTime frameDescription
Association of functional connectivity change with changes in depression symptoms6 monthsCenter for Epidemiological Studies-Depression Scale (CES-D)
Association of functional connectivity with maintenance of weight loss6 monthsBMI

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026