- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01169428
Engaging Motivation for the Prevention of Weight Regain (EMPOWER)
Mindfulness Based Weight Loss Maintenance
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke University - Duke Integrative Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania, Program for Mindfulness
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: 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 Criteria:
- 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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard Behavioral Weight-Loss Maintenence
Attention/Education/Support Control Group designed to control for educational content as well as multiple nonspecific treatment factors (e.g., support, time invested, leader attention, positive expectancy) |
Attention/Education/Support Control group, designed to control for educational content as well as nonspecific treatment factors [e.g., natural history (time), amount of time and energy spent in the intervention, attention by group leaders, social support, as well as information & education].
Like the experimental group(MBWLM), this group meet once a week for 2 hours during the 12-week intervention, and then at 4 weeks, 8 weeks, and 12 weeks post the 12 week intervention.
Participants also receive the same amount of telephonic support through Maintenance Partners as the experimental group, but their Maintenance Partners employed empathic listening only rather than myriad coaching techniques.
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Active Comparator: Behavioral: Mindfulness Based Weight Loss Maintenance (MBWLM)
This mindfulness-meditation based intervention is designed to increase awareness of the factors that affect weight loss maintenance after successful weight loss.
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This mindfulness-meditation based intervention is designed to increase awareness of the factors that affect weight loss maintenance after successful weight loss.
Mindfulness meditation is a technique for training awareness.
The program will train subjects to increase awareness of the somatic, cognitive, affective, interpersonal and environmental factors that mediate eating and physical activity by incorporating empirically-supported and theoretically-synergized components, including: general mindfulness meditation skills, mindful and intuitive eating, appetite-satiety awareness, mindful movement and yoga, a mindful approach to exercise engagement, and training in enhancing emotion regulation and stress management skills.
In addition, the MBWLM group will be supported by Maintenance Partners who are trained as Integrative Health Coaches.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight Loss Maintenance
Time Frame: 16-month
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Our primary endpoint will be an evaluation of differential weight loss maintenance (WLM) or weight regain between the two conditions.
All weight measures will be taken on the Tanita scale in a standardized fashion, in the morning following a 12 hour fast, after voiding and in bare feet while wearing a standardized outfit.
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16-month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index
Time Frame: 16-month
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BMI is the most widely accepted indicator of overweight and obesity.
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16-month
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Waist circumference
Time Frame: 16 month
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Waist circumference will be assessed using methods prescribed by the United States Department of Health and Human Services.
The point of measurement will be determined by locating the right iliac crest.
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16 month
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Percent Body Fat
Time Frame: 16 month
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Total body fat will be assessed using a bioelectrical impedance scale (Tanita Scale).
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16 month
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Psychological outcomes and lifestyle behavior
Time Frame: 16-month
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Questionnaires used to measure these outcomes, included POMS,PSS,SF-12, BES,IES,IPAQ,Modified Block Food Frequency Questionnaire,CAMS-R, 5-Factor Mindfulness Questionnaire,TAS-20
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16-month
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Biological markers of appetite
Time Frame: 16 months
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Assessed by serum Leptin, Ghrelin, PYY
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16 months
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Glucose metabolism
Time Frame: 16 months
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Evaluated by fasting serum glucose, postprandial glucose, fasting insulin, postprandial insulin, hemoglobin A1C
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16 months
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Biological markers of inflammation
Time Frame: 16 months
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Inflamation assessed by serum Interleukin-6 and serum C-Reactive Protein
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16 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ruth Q Wolever, PhD, Duke University
- Principal Investigator: Michael Baime, M.D, University of PENN, Program for Stress Management
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00013688
- U01AT004159 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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