Engaging Motivation for the Prevention of Weight Regain

Completed · Phase 2

Conditions studied: Obesity

In brief

The purpose of this study is to determine whether a 12 week Mindfulness-Based Weight Loss Maintenance (MBWLM) intervention is effective in maintaining recent loss of 10% or more of initial body weight.

Key facts

Study ID

NCT01169428

Run by

Duke University

People needed

95

Starts

2007-07-01

Expected to finish

2010-06-01

Last updated by the study team

2013-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Concurrent participation in a structured weight loss program, fad diet or use of weight loss medication or herbal supplements during 15 month course of the trial. If has been taking a weight loss medication or supplement, must go through a 1 month washout period before enrollment.
• Previous weight reduction surgery, or initiating weight reduction surgery during the 15 month study period.
• Inability to participate fully or behave appropriately in the group setting, as observed by (a). interviewing clinician and evidenced by two or more of the exclusionary criteria on the Appropriateness for Group Participation Behavioral Checklist or (b) baseline acknowledgement of substance abuse, psychotic episode(s), psychiatric hospitalization or history of self-harm within the past 2 years, or current suicidal or homicidal ideation.
• Unstable medical condition, medical condition underlying weight or eating problems (e.g., Blood sugar greater than 350, Cancer and currently receiving radiation or chemo treatment, Cushing's Syndrome; thyroid disorder) or medical condition requiring strict dietary regimen.
• Pregnant, breast-feeding, or unwilling to take contraceptive measures to prevent pregnancy during the 15 month study. If a woman has recently been pregnant, is currently nursing, or recently quit nursing, she must have stopped nursing and had 3 normal menstrual cycles or be using approved contraceptive measures for 3 months before being eligible.
• Meeting diagnostic criteria for purging bulimia.
• More than 1.5 hours of exposure to meditation-based eating or weight control techniques.
• More than 60 minutes per week, for a consecutive 4 week time period, during the last 2 years, of regular sitting (Mindfulness Based Stress Reduction, Transcendental Meditation, or other meditation practice) meditation practice.
• Not willing to be randomized.
• No other household members can participate.
• Baseline glucometer reading of >125 for previously unknown diabetics, as this is likely to indicate undiagnosed diabetes that would require more intensive treatment.
• Known diabetes likely to require more intensive treatment, defined as a baseline glucometer reading > 350 or the inability to maintain a stable diabetes medication regimen for the previous 6 months.

Where it is running

• Duke University - Duke Integrative Medicine — Durham, North Carolina, United States
• University of Pennsylvania, Program for Mindfulness — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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