Engaging Motivation for the Prevention of Weight Regain (EMPOWER)
|ClinicalTrials.gov Identifier: NCT01169428|
Recruitment Status : Completed
First Posted : July 26, 2010
Last Update Posted : March 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Mindfulness Based Weight Loss Maintenance (MBWLM) Behavioral: Behavioral: Standard Behavioral Weight-Loss Maintenence||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Mindfulness Based Weight Loss Maintenance|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||June 2010|
Active Comparator: Standard Behavioral Weight-Loss Maintenence
Group designed to control for educational content as well as multiple nonspecific treatment factors (e.g., support, time invested, leader attention, positive expectancy)
Behavioral: Behavioral: Standard Behavioral Weight-Loss Maintenence
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.
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.
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. 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.
- Weight Loss Maintenance [ Time Frame: 16-month ]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.
- Body Mass Index [ Time Frame: 16-month ]BMI is the most widely accepted indicator of overweight and obesity.
- Waist circumference [ Time Frame: 16 month ]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.
- Percent Body Fat [ Time Frame: 16 month ]Total body fat will be assessed using a bioelectrical impedance scale (Tanita Scale).
- Psychological outcomes and lifestyle behavior [ Time Frame: 16-month ]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
- Biological markers of appetite [ Time Frame: 16 months ]Assessed by serum Leptin, Ghrelin, PYY
- Glucose metabolism [ Time Frame: 16 months ]Evaluated by fasting serum glucose, postprandial glucose, fasting insulin, postprandial insulin, hemoglobin A1C
- Biological markers of inflammation [ Time Frame: 16 months ]Inflamation assessed by serum Interleukin-6 and serum C-Reactive Protein
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169428
|United States, North Carolina|
|Duke University - Duke Integrative Medicine|
|Durham, North Carolina, United States, 27705|
|United States, Pennsylvania|
|University of Pennsylvania, Program for Mindfulness|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Ruth Q Wolever, PhD||Duke University|
|Principal Investigator:||Michael Baime, M.D||University of PENN, Program for Stress Management|