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A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery

Beth Israel Lahey Health logo

Beth Israel Lahey Health

Status

Completed

Conditions

Weight Gain
Obesity

Treatments

Behavioral: Standard lifestyle intervention
Behavioral: Mind-body lifestyle intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02603601
2013P000259

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

18 participants in 2 patient groups

Standard lifestyle intervention
Active Comparator group
Description:
The standard lifestyle intervention is a 1-hour individual nutritional counseling session with a registered dietician at BIDMC.
Treatment:
Behavioral: Standard lifestyle intervention
Mind-body lifestyle intervention
Experimental group
Description:
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.
Treatment:
Behavioral: Mind-body lifestyle intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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