Engaging Motivation for the Prevention of Weight Regain

NCT01169428 | Completed Phase 2 DMC

• 2 other identifiers: Pro00013688U01AT004159
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Keywords

Mindfulness-Based Weight Loss Maintenance; prevention of weight regain; Obesity

Outcome Measures

Primary Outcomes (1)

• Weight Loss Maintenance

  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.

  16-month

Secondary Outcomes (7)

• Body Mass Index

  16-month

• Waist circumference

  16 month

• Percent Body Fat

  16 month

• Psychological outcomes and lifestyle behavior

  16-month

• Biological markers of appetite

  16 months

Study Arms (2)

Standard Behavioral Weight-Loss Maintenence

ACTIVE COMPARATOR

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)

Behavioral: Behavioral: Standard Behavioral Weight-Loss Maintenence

Behavioral: Mindfulness Based Weight Loss Maintenance (MBWLM)

ACTIVE COMPARATOR

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)

Interventions

Mindfulness Based Weight Loss Maintenance (MBWLM) BEHAVIORAL

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.

Behavioral: Mindfulness Based Weight Loss Maintenance (MBWLM)

Behavioral: Standard Behavioral Weight-Loss Maintenence BEHAVIORAL

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.

Standard Behavioral Weight-Loss Maintenence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.
• \) Willingness to not engage in any other formal weight loss program through the 12 month follow-up.
• \) 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.

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.
• 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.

Sponsors & Collaborators

• Duke University: lead
• University of Pennsylvania: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

Duke University - Duke Integrative Medicine

Durham, North Carolina, 27705, United States

Location

University of Pennsylvania, Program for Mindfulness

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruth Q Wolever, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Michael Baime, M.D

  University of PENN, Program for Stress Management

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 26, 2010
• Study Start: July 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: June 1, 2010
• Last Updated: March 14, 2013

Record last verified: 2013-03

Locations

US (2)