AzTrials
AzTrials

ObesityPhase 2EMPOWERNCT01169428

Engaging Motivation for the Prevention of Weight Regain

A Phase 2 study testing Mindfulness Based Weight Loss Maintenance (MBWLM) and Behavioral: Standard Behavioral Weight-Loss Maintenence in people with Obesity, run by Duke University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Mindfulness Based Weight Loss Maintenance (MBWLM) and Behavioral: Standard Behavioral Weight-Loss Maintenence
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
2 sitesUnited States
Study dates
Jul 2007to Jun 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.
  • -

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Duke University - Duke Integrative Medicine

    Durham, North Carolina, 27705

  • University of Pennsylvania, Program for Mindfulness

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Mindfulness Based Weight Loss Maintenance

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.

Read the 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.

Conditions
Obesity
Being tested
Mindfulness Based Weight Loss Maintenance (MBWLM), Behavioral: Standard Behavioral Weight-Loss Maintenence
Keywords
Mindfulness-Based Weight Loss Maintenance, prevention of weight regain, Obesity
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness Based Weight Loss Maintenance (MBWLM)Behavioural

    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: Standard Behavioral Weight-Loss MaintenenceBehavioural

    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.

Study groups in NCT01169428
Study groupRoleWhat they receive
Standard Behavioral Weight-Loss MaintenenceActive comparatorAttention/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)
Receives: Behavioral: Behavioral: Standard Behavioral Weight-Loss Maintenence
Behavioral: Mindfulness Based Weight Loss Maintenance (MBWLM)Active comparatorThis mindfulness-meditation based intervention is designed to increase awareness of the factors that affect weight loss maintenance after successful weight loss.
Receives: Behavioral: Mindfulness Based Weight Loss Maintenance (MBWLM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 16-month

Secondary outcomes (7)

  1. Body Mass Index

    BMI is the most widely accepted indicator of overweight and obesity.

    Measured: 16-month

  2. Waist circumference

    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.

    Measured: 16 month

  3. Percent Body Fat

    Total body fat will be assessed using a bioelectrical impedance scale (Tanita Scale).

    Measured: 16 month

  4. Psychological outcomes and lifestyle behavior

    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

    Measured: 16-month

  5. Biological markers of appetite

    Assessed by serum Leptin, Ghrelin, PYY

    Measured: 16 months

  6. Glucose metabolism

    Evaluated by fasting serum glucose, postprandial glucose, fasting insulin, postprandial insulin, hemoglobin A1C

    Measured: 16 months

  7. Biological markers of inflammation

    Inflamation assessed by serum Interleukin-6 and serum C-Reactive Protein

    Measured: 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2010 (estimated)
  2. Study startJul 2007
  3. Primary completionJul 2009
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01169428
Sponsor's protocol ID
Pro00013688
Other IDs
U01AT004159
Acronym
EMPOWER
Status last verified
Mar 2013
First submitted
22 Jul 2010
Last updated
14 Mar 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mindfulness Based Weight Loss Maintenance (MBWLM) and Behavioral: Standard Behavioral Weight-Loss Maintenence in people with Obesity, run by Duke University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Loss Maintenance (time frame: 16-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01169428.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in