NCT02603601

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
9 months until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

February 4, 2015

Last Update Submit

May 2, 2017

Conditions

ObesityWeight Gain

Keywords

Randomized controlled trialMindfulnessObesity

Outcome Measures

Primary Outcomes (4)

  • Success meeting recruitment goals (20 patients within 3-4 months)

    4-month recruitment window

  • Willingness to participate in study (>10% of eligible)

    4-month recuitment window

  • Adherence rate (≥70% attendance, 7 of 10 classes)

    12-weeks

  • Retention (≤25% drop-out)

    6-months

Secondary Outcomes (9)

  • Changes in body weight as measured on a digital scale

    12 ± 2 weeks post intervention-baseline

  • Eating behaviors measured using the Three Factor Eating Questionnaire

    12 ± 2 weeks

  • Eating behaviors measured using the Binge Eating Scale

    12 ± 2 weeks

  • Quality of life measured using the Medical Outcomes Study Short-Form-36 scale

    12 ± 2 weeks

  • Quality of life measured using the Impact of Weight on Quality of Life scale

    12 ± 2 weeks

  • +4 more secondary outcomes

Other Outcomes (3)

  • Biomarkers of stress measured by bioassay techniques

    12 ± 2 weeks

  • Biomarkers of inflammation measured by bioassay techniques

    12 ± 2 weeks

  • Food-related attentional bias as measured by the Food-related Stroop task.

    12 ± 2 weeks

Study Arms (2)

Standard lifestyle intervention

ACTIVE COMPARATOR

The standard lifestyle intervention is a 1-hour individual nutritional counseling session with a registered dietician at BIDMC.

Behavioral: Standard lifestyle intervention

Mind-body lifestyle intervention

EXPERIMENTAL

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

Interventions

Mind-body lifestyle interventionBEHAVIORAL
Mind-body lifestyle intervention
Standard lifestyle interventionBEHAVIORAL
Standard lifestyle intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).
  • Plans to leave the study area within next 12 months
  • Serious psychiatric illness or personality disorder (by medical record and/or self-report)
  • Current alcohol and/or substance abuse
  • Pregnancy or plans to become pregnant in next year
  • Non-English speaking
  • \> 1 prior weight loss surgery (by medical record and self-report)
  • Gastric band removed prior to study contact.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconness Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

    PMID: 27670865DERIVED

MeSH Terms

Conditions

ObesityWeight Gain

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Christina C Wee, MD, MPH

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 4, 2015

First Posted

November 13, 2015

Study Start

March 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

US(1)