Clinical trial NCT01169428: Engaging Motivation for the Prevention of Weight Regain
Official title: Mindfulness Based Weight Loss Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Mindfulness-Based Weight Loss Maintenance
prevention of weight regain
Obesity
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-07-26
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 weight loss, a burgeoning literature reveals less encouraging results for weight loss maintenance (WLM). Hence, innovative approaches to WLM are necessary to buffer against disease risks associated with weight regain. Interventions utilizing mindfulness meditation show promise in treating unhealthy eating behaviors and other obesity-related problems, including mood, blood sugar control and addiction. By enhancing self-awareness and emotion regulation, such interventions may be particularly useful in facilitating the internalization of healthy behavior change. The proposed study aims to develop a novel intervention to promote WLM. Specifically, we will develop a 12 week Mindfulness-Based Weight Loss Maintenance (MBWLM) intervention and test its efficacy against an attention/education/support control (ASC) condition in a two-arm RCT of overweight and obese (BMI \> 25) men and women (N=95) who recently lost at least 10% of their initial body weight via non-surgical means. The primary endpoint will be percent change in weight from baseline to 12-month follow-up. We are also interested in testing the efficacy of the MBWLM program on improving secondary outcomes, including obesity/adiposity, health behaviors, and psychological well-being. In addition, we will study the impact of MBWLM on glucose metabolism, appetite/food intake regulation, and systemic inflammation. Outcome data will be collected at baseline, post-intervention, 6-month follow-up and 12-month follow-up. Multilevel ("mixed-effects") modeling will be used to test between-group differences on primary and secondary endpoints. Further, path analysis will be used to investigate mechanisms underlying successful WLM. Taken together, these data could provide support for the integration of mindfulness meditation into comprehensive treatment programs for obesity and weight management.

Eligibility criteria: 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:

1. 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.
2. Previous weight reduction surgery, or initiating weight reduction surgery during the 15 month study period.
3. 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.
4. 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.
5. 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.
6. Meeting diagnostic criteria for purging bulimia.
7. More than 1.5 hours of exposure to meditation-based eating or weight control techniques.
8. 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.
9. Not willing to be randomized.
10. No other household members can participate.
11. Baseline glucometer reading of \>125 for previously unknown diabetics, as this is likely to indicate undiagnosed diabetes that would require more intensive treatment.
12. 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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Primary outcomes:
measure: Weight Loss Maintenance
timeFrame: 16-month
Secondary outcomes:
measure: Body Mass Index
timeFrame: 16-month
measure: Waist circumference
timeFrame: 16 month
measure: Percent Body Fat
timeFrame: 16 month
measure: Psychological outcomes and lifestyle behavior
timeFrame: 16-month
measure: Biological markers of appetite
timeFrame: 16 months
measure: Glucose metabolism
timeFrame: 16 months
measure: Biological markers of inflammation
timeFrame: 16 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University - Duke Integrative Medicine
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania, Program for Mindfulness
state: Pennsylvania
Study officials:
affiliation: Duke University
name: Ruth Q Wolever, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of PENN, Program for Stress Management
name: Michael Baime, M.D
role: PRINCIPAL_INVESTIGATOR
References: