Post-Bariatric Weight Regain Behavioral Intervention

Obesity Clinical Trial

Official title:

The Investigation of a Remotely Delivered Behavioral Intervention for Postoperative Weight Regain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03564392
• Other study ID #: 16062305
• Status: Completed
• Phase: N/A
• Start date: March 28, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: March 2019
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Has undergone any type of weight loss surgery at least 1.5 years ago

• Demonstrate = 10% weight regain of maximum weight loss or 5% of their minimum weight post-surgery, with weight regain lasting for at least 3 months prior to enrollment.

• Ability to give consent and speak, write, and understand English.

Exclusion Criteria:

• Currently enrolled in structured weight loss program

• Currently pregnant/plan to become pregnant within 6 months of enrollment

• Have a serious medical condition that has the potential of affecting weight or that would prevent engagement in dietary changes and/or an exercise regimen

• Exhibit psychiatric symptoms that would interfere with the ability to benefit from the intervention, or report acute suicidality

• Non-ambulatory (i.e., unable to walk at least one city block without a cane or walker at the time of screening

• Use of medications known to affect body weight, such as chronic systemic steroids or psychiatric medications including lithium, tricyclic antidepressants, and antipsychotic agents

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Acceptance Based Behavioral Intervention
This intervention focuses on acceptance-based strategies with an emphasis on willingness to experience less pleasurable internal experiences (e.g., pleasure from eating calorically-dense foods) and aversive internal experiences (e.g., hunger, food cravings). Strategies to increase this willingness will be taught, including defusion (i.e., getting psychological distance from internal experiences to allow oneself to act independently of them). Mindful decision-making, as it relates to eating and exercise, will also be emphasized. Clarification and commitment to core values is another key component, as living life in accordance with one's values (e.g., health) makes willingness to make difficult choices worthwhile. Standard behavioral techniques for weight loss (i.e., self-monitoring, stimulus control, psychoeducation) will also be included.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		10 weeks
Secondary	Loss of Control Eating Scale (LOCES)	LOCES measures loss of control eating.	10 weeks
Secondary	Repetitive Eating Assessment-Questionnaire (Rep(eat))	Rep(eat) measures grazing behaviors.	10 weeks
Secondary	Emotional Eating Scale (EES)	EES will be used to measure emotional eating	10 weeks
Secondary	The Eating Inventory	The Eating Inventory will be used to measure disinhibition.	10 weeks
Secondary	Paffenbarger Physical Activity Recall	Paffenbarger will be used to measure physical activity engagement	10 weeks
Secondary	Philadelphia Mindfulness Scale (PHLMS)	PHLMS will be used to measure mindfulness	10 weeks
Secondary	Drexel Defusion Scale (DDS)	DDS will be used to measure delusion (a psychological construct of cognitive distancing)	10 weeks
Secondary	Food-Related Acceptance and Action Questionnaire (FAAQ)	FAAQ will be used to measure food-related acceptance	10 weeks