A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery
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|ClinicalTrials.gov Identifier: NCT02603601|
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : May 3, 2017
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.
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.
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Success meeting recruitment goals (20 patients within 3-4 months) [ Time Frame: 4-month recruitment window ]
- Willingness to participate in study (>10% of eligible) [ Time Frame: 4-month recuitment window ]
- Adherence rate (≥70% attendance, 7 of 10 classes) [ Time Frame: 12-weeks ]
- Retention (≤25% drop-out) [ Time Frame: 6-months ]
- Changes in body weight as measured on a digital scale [ Time Frame: 12 ± 2 weeks post intervention-baseline ]
- Eating behaviors measured using the Three Factor Eating Questionnaire [ Time Frame: 12 ± 2 weeks ]
- Eating behaviors measured using the Binge Eating Scale [ Time Frame: 12 ± 2 weeks ]
- Quality of life measured using the Medical Outcomes Study Short-Form-36 scale [ Time Frame: 12 ± 2 weeks ]
- Quality of life measured using the Impact of Weight on Quality of Life scale [ Time Frame: 12 ± 2 weeks ]
- Depression measured by the Center for Epidemiologic Studies Depression Scale [ Time Frame: 12 ± 2 weeks ]
- Perceived stress measured by the Perceived Stress Scale [ Time Frame: 12 ± 2 weeks ]
- Ability to cope measured by the Brief Cope questionnaire [ Time Frame: 12 ± 2 weeks ]
- Eating self-efficacy measured by the Weight Efficacy Lifestyle Questionnaire [ Time Frame: 12 ± 2 weeks ]
- Biomarkers of stress measured by bioassay techniques [ Time Frame: 12 ± 2 weeks ]
- Biomarkers of inflammation measured by bioassay techniques [ Time Frame: 12 ± 2 weeks ]
- Food-related attentional bias as measured by the Food-related Stroop task. [ Time Frame: 12 ± 2 weeks ]
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
|United States, Massachusetts|
|Beth Israel Deaconness Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Christina C Wee, MD, MPH||Beth Israel Deaconess Medical Center|