Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-01 @ 5:33 PM
Study NCT ID:
NCT03564392
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2018-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Bariatric Weight Regain Behavioral Intervention
Sponsor:
Rush University Medical Center
Organization:
Study Overview
Official Title:
The Investigation of a Remotely Delivered Behavioral Intervention for Postoperative Weight Regain
Status:
COMPLETED
Status Verified Date:
2019-03
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 project aims to evaluate a newly developed Internet-delivered (via e-learning modules) acceptance-based behavioral intervention (ABTi) for individuals who are experiencing weight regain after bariatric surgery. Specifically, the investigators aim to assess ABTi's efficacy on stopping and/or reversing weight by comparing it to a wait-list control (WLC) condition. The investigators also aim to evaluate its effect on targeted weight control behaviors and acceptance-based skills. Finally, the investigators will examine the relationship between weight outcomes and changes in process variables through exploratory analyses. Treatment outcomes (i.e., weight, maladaptive behaviors, physical activity, acceptance-based skills) will be measured at assessments pre-, mid-, and post-treatment, as well as at 3 months after treatment has ended.
Primary Aims.
1. To test the hypothesis that participants randomly assigned to ABTi will display greater weight loss from pre- to post-treatment than those assigned to WLC.
2. To test the hypothesis those receiving ABTi, compared to WLC, will display decreased maladaptive eating behaviors (i.e., loss of control episodes, grazing, emotional eating, disinhibition), increased physical activity, and greater improvements in acceptance-based skills (i.e., mindfulness, defusion, food-related acceptance).
Exploratory Aim.
(1) To assess if changes in acceptance-based skills, maladaptive eating behaviors, and physical activity are associated with pre- to post-treatment weight outcomes.
Primary Aims.
1. To test the hypothesis that participants randomly assigned to ABTi will display greater weight loss from pre- to post-treatment than those assigned to WLC.
2. To test the hypothesis those receiving ABTi, compared to WLC, will display decreased maladaptive eating behaviors (i.e., loss of control episodes, grazing, emotional eating, disinhibition), increased physical activity, and greater improvements in acceptance-based skills (i.e., mindfulness, defusion, food-related acceptance).
Exploratory Aim.
(1) To assess if changes in acceptance-based skills, maladaptive eating behaviors, and physical activity are associated with pre- to post-treatment weight outcomes.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: