NCT03564392

Post-Bariatric Weight Regain Behavioral Intervention

Completed NA Last updated 28 March 2019

What this trial tests

NA trial testing Acceptance Based Behavioral Intervention in Obesity in 74 participants. Completed in 31 January 2019.

Timeline

28 March 2017

Primary endpoint
31 January 2019

31 January 2019

Quick facts

Lead sponsor	Rush University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	74
Start date	28 March 2017
Primary completion	31 January 2019
Estimated completion	31 January 2019
Sites	1 location across United States

Drugs / interventions tested

• Acceptance Based Behavioral Intervention

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Rush University Medical Center

Who can join

Adults 18 to 70, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.