A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603601
• Other study ID #: 2013P000259
• Status: Completed
• Phase: N/A
• First received: February 4, 2015
• Last updated: May 2, 2017
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: May 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Gain

Intervention

Behavioral:
• Mind-body lifestyle intervention

• Standard lifestyle intervention

Locations

Country	Name	City	State
United States	Beth Israel Deaconness Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Center for Nutritional Research Charitable Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarkers of stress measured by bioassay techniques		12 ± 2 weeks
Other	Biomarkers of inflammation measured by bioassay techniques		12 ± 2 weeks
Other	Food-related attentional bias as measured by the Food-related Stroop task.		12 ± 2 weeks
Primary	Success meeting recruitment goals (20 patients within 3-4 months)		4-month recruitment window
Primary	Willingness to participate in study (>10% of eligible)		4-month recuitment window
Primary	Adherence rate (=70% attendance, 7 of 10 classes)		12-weeks
Primary	Retention (=25% drop-out)		6-months
Secondary	Changes in body weight as measured on a digital scale		12 ± 2 weeks post intervention-baseline
Secondary	Eating behaviors measured using the Three Factor Eating Questionnaire		12 ± 2 weeks
Secondary	Eating behaviors measured using the Binge Eating Scale		12 ± 2 weeks
Secondary	Quality of life measured using the Medical Outcomes Study Short-Form-36 scale		12 ± 2 weeks
Secondary	Quality of life measured using the Impact of Weight on Quality of Life scale		12 ± 2 weeks
Secondary	Depression measured by the Center for Epidemiologic Studies Depression Scale		12 ± 2 weeks
Secondary	Perceived stress measured by the Perceived Stress Scale		12 ± 2 weeks
Secondary	Ability to cope measured by the Brief Cope questionnaire		12 ± 2 weeks
Secondary	Eating self-efficacy measured by the Weight Efficacy Lifestyle Questionnaire		12 ± 2 weeks