Ignite Creation Date:
2024-05-06 @ 7:47 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
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
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