Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02603601
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
Center for Nutritional Research Charitable Trust
Information provided by (Responsible Party):
Christina Wee, Beth Israel Deaconess Medical Center

Brief Summary:

This randomized controlled trial is designed to test the feasibility and efficacy of a novel 10-week mindfulness-based intervention (MBI) on weight maintenance as well as behavioral and psychosocial outcomes in patients who have undergone bariatric surgery.

Primary hypothesis:

Bariatric patients who have stopped losing weight (< 5 lbs weight loss in past month) 1-5 years post-surgery will be willing to participate in this 10-week intervention. The investigators expect a high adherence rate (>70%) and no issues with meeting recruitment goals.

Secondary hypotheses:

Patients assigned to the MBI will show greater improvement in a) weight control (defined by differences in body weight between baseline and follow-up); b) eating behaviors (binge eating, emotional eating); and c) psychosocial measures (quality of life, depression, perceived stress, eating self-efficacy, coping ability) than a standard lifestyle intervention (1 hr lifestyle counseling).

Patients assigned to the MBI intervention will show greater improvement in biomarkers of stress and inflammation [salivary cortisol, high sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha)] as compared with a standard lifestyle intervention.

Food-related attentional bias as measured by the food-related Stroop task will be differentially affected among patients assigned to the MBI as compared with the intensive lifestyle intervention and standard lifestyle intervention.


Condition or disease Intervention/treatment Phase
Obesity Weight Gain Behavioral: Mind-body lifestyle intervention Behavioral: Standard lifestyle intervention Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery
Study Start Date : March 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard lifestyle intervention
The standard lifestyle intervention is a 1-hour individual nutritional counseling session with a registered dietician at BIDMC.
Behavioral: Standard lifestyle intervention
Experimental: Mind-body lifestyle intervention
The mind-body lifestyle intervention is a 10-week mindfulness-based intervention that integrates mindfulness with traditional behavioral strategies to improve long-term weight maintenance.
Behavioral: Mind-body lifestyle intervention



Primary Outcome Measures :
  1. Success meeting recruitment goals (20 patients within 3-4 months) [ Time Frame: 4-month recruitment window ]
  2. Willingness to participate in study (>10% of eligible) [ Time Frame: 4-month recuitment window ]
  3. Adherence rate (≥70% attendance, 7 of 10 classes) [ Time Frame: 12-weeks ]
  4. Retention (≤25% drop-out) [ Time Frame: 6-months ]

Secondary Outcome Measures :
  1. Changes in body weight as measured on a digital scale [ Time Frame: 12 ± 2 weeks post intervention-baseline ]
  2. Eating behaviors measured using the Three Factor Eating Questionnaire [ Time Frame: 12 ± 2 weeks ]
  3. Eating behaviors measured using the Binge Eating Scale [ Time Frame: 12 ± 2 weeks ]
  4. Quality of life measured using the Medical Outcomes Study Short-Form-36 scale [ Time Frame: 12 ± 2 weeks ]
  5. Quality of life measured using the Impact of Weight on Quality of Life scale [ Time Frame: 12 ± 2 weeks ]
  6. Depression measured by the Center for Epidemiologic Studies Depression Scale [ Time Frame: 12 ± 2 weeks ]
  7. Perceived stress measured by the Perceived Stress Scale [ Time Frame: 12 ± 2 weeks ]
  8. Ability to cope measured by the Brief Cope questionnaire [ Time Frame: 12 ± 2 weeks ]
  9. Eating self-efficacy measured by the Weight Efficacy Lifestyle Questionnaire [ Time Frame: 12 ± 2 weeks ]

Other Outcome Measures:
  1. Biomarkers of stress measured by bioassay techniques [ Time Frame: 12 ± 2 weeks ]
  2. Biomarkers of inflammation measured by bioassay techniques [ Time Frame: 12 ± 2 weeks ]
  3. Food-related attentional bias as measured by the Food-related Stroop task. [ Time Frame: 12 ± 2 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who have undergone bariatric surgery 1-5 years prior to study start (by medical record and/or self report)
  2. Weight loss plateau (< 5 lbs weight loss in past month) (by medical report and/or self report)
  3. Ages 18-65 years (by medical record and/or self report)
  4. Able to complete outcome assessments

Exclusion Criteria:

  1. Prior experience with meditation course (past 6 months), current mindfulness/meditation practice, or regular meditation or mindfulness practice in past year ("Regular practice" defined as practicing formally 1 or more times a week for 2 months).
  2. Plans to leave the study area within next 12 months
  3. Serious psychiatric illness or personality disorder (by medical record and/or self-report)
  4. Current alcohol and/or substance abuse
  5. Pregnancy or plans to become pregnant in next year
  6. Non-English speaking
  7. > 1 prior weight loss surgery (by medical record and self-report)
  8. Gastric band removed prior to study contact.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603601


Locations
Layout table for location information
United States, Massachusetts
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Center for Nutritional Research Charitable Trust
Investigators
Layout table for investigator information
Principal Investigator: Christina C Wee, MD, MPH Beth Israel Deaconess Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Christina Wee, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02603601    
Other Study ID Numbers: 2013P000259
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Keywords provided by Christina Wee, Beth Israel Deaconess Medical Center:
Randomized controlled trial
Mindfulness
Obesity
Additional relevant MeSH terms:
Layout table for MeSH terms
Body Weight
Weight Gain
Body Weight Changes