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Post-Bariatric Weight Regain Behavioral Intervention

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03564392
Enrollment
74
Registered
2018-06-20
Start date
2017-03-28
Completion date
2019-01-31
Last updated
2019-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

BEHAVIORALAcceptance 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.

Sponsors

Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Weight loss10 weeks

Secondary

MeasureTime frameDescription
Loss of Control Eating Scale (LOCES)10 weeksLOCES measures loss of control eating.
Repetitive Eating Assessment-Questionnaire (Rep(eat))10 weeksRep(eat) measures grazing behaviors.
Emotional Eating Scale (EES)10 weeksEES will be used to measure emotional eating
The Eating Inventory10 weeksThe Eating Inventory will be used to measure disinhibition.
Philadelphia Mindfulness Scale (PHLMS)10 weeksPHLMS will be used to measure mindfulness
Drexel Defusion Scale (DDS)10 weeksDDS will be used to measure delusion (a psychological construct of cognitive distancing)
Food-Related Acceptance and Action Questionnaire (FAAQ)10 weeksFAAQ will be used to measure food-related acceptance
Paffenbarger Physical Activity Recall10 weeksPaffenbarger will be used to measure physical activity engagement

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026