Status:
COMPLETED
Engaging Motivation for the Prevention of Weight Regain
Lead Sponsor:
Duke University
Collaborating Sponsors:
University of Pennsylvania
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Obesity is now recognized as the 2nd leading cause of preventable death in the U.S. and is associated with significant impairment. While structured behavioral regimes typically lead to significant wei...
Eligibility Criteria
Inclusion
- 1) Gender: Men and women. 2) Ethnicity: Any, with over-sampling of African-Americans. 3) Age: \>18 4) Weight: BMI \> 20 at study entry. 5) Documented (by physician, community weight loss program, personal friend or family member) weight loss of at least 9% of total body weight completed within the previous 3 year period and not regained greater than half of the 9% loss.
- 6\) Planning to be in the area through the length of follow-up. 7) Availability of telephone. 8) English-speaking and English-literate. 9) Commitment to attend all treatment and assessment appointments. 10) If on medication that may affect outcome variables, on stable dose with willingness to remain at that dose from baseline through end of weekly (12-week) intervention and 12 month follow-up, unless physician orders otherwise.
- 11\) Willingness to not engage in any other formal weight loss program through the 12 month follow-up.
- 12\) Provides Informed consent. 13) Participants can have a weight loss or gain of more than 8.8lbs within the 3 month period prior to enrollment. However, due to the possibility that this will influence baseline inflammatory bio markers we will document the amount of self-reported weight change within the 3 month period prior to their baseline lab appointment.
Exclusion
- 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.
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Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT01169428
Start Date
July 1 2007
End Date
June 1 2010
Last Update
March 14 2013
Active Locations (2)
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1
Duke University - Duke Integrative Medicine
Durham, North Carolina, United States, 27705
2
University of Pennsylvania, Program for Mindfulness
Philadelphia, Pennsylvania, United States, 19104