Viewing Study NCT02603601



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Study NCT ID: NCT02603601
Status: COMPLETED
Last Update Posted: 2017-05-03
First Post: 2015-02-04

Brief Title: A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery
Sponsor: Beth Israel Deaconess Medical Center
Organization: Beth Israel Deaconess Medical Center

Study Overview

Official Title: A Randomized Controlled Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery
Status: COMPLETED
Status Verified Date: 2017-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None