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Completed

NCT Number: NCT02603601

A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconness Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Mind-body lifestyle intervention

Behavioral

Standard Lifestyle Intervention

Behavioral

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Center for Nutritional Research Charitable Trust

Registry information

Official study title

A Randomized Controlled Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 13, 2015
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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