Clinical trial NCT02603601: A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery
Official title: A Randomized Controlled Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Gain
Keywords: Randomized controlled trial
Mindfulness
Obesity
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Center for Nutritional Research Charitable Trust
First posted: 2015-11-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Success meeting recruitment goals (20 patients within 3-4 months)
timeFrame: 4-month recruitment window
measure: Willingness to participate in study (>10% of eligible)
timeFrame: 4-month recuitment window
measure: Adherence rate (≥70% attendance, 7 of 10 classes)
timeFrame: 12-weeks
measure: Retention (≤25% drop-out)
timeFrame: 6-months
Secondary outcomes:
measure: Changes in body weight as measured on a digital scale
timeFrame: 12 ± 2 weeks post intervention-baseline
measure: Eating behaviors measured using the Three Factor Eating Questionnaire
timeFrame: 12 ± 2 weeks
measure: Eating behaviors measured using the Binge Eating Scale
timeFrame: 12 ± 2 weeks
measure: Quality of life measured using the Medical Outcomes Study Short-Form-36 scale
timeFrame: 12 ± 2 weeks
measure: Quality of life measured using the Impact of Weight on Quality of Life scale
timeFrame: 12 ± 2 weeks
measure: Depression measured by the Center for Epidemiologic Studies Depression Scale
timeFrame: 12 ± 2 weeks
measure: Perceived stress measured by the Perceived Stress Scale
timeFrame: 12 ± 2 weeks
measure: Ability to cope measured by the Brief Cope questionnaire
timeFrame: 12 ± 2 weeks
measure: Eating self-efficacy measured by the Weight Efficacy Lifestyle Questionnaire
timeFrame: 12 ± 2 weeks
Other outcomes:
measure: Biomarkers of stress measured by bioassay techniques
timeFrame: 12 ± 2 weeks
measure: Biomarkers of inflammation measured by bioassay techniques
timeFrame: 12 ± 2 weeks
measure: Food-related attentional bias as measured by the Food-related Stroop task.
timeFrame: 12 ± 2 weeks
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconness Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Christina C Wee, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chacko SA, Yeh GY, Davis RB, Wee CC. A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial. Complement Ther Med. 2016 Oct;28:13-21. doi: 10.1016/j.ctim.2016.07.001. Epub 2016 Jul 12.