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Completed

NCT Number: NCT03564392

Post-Bariatric Weight Regain Behavioral Intervention

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acceptance Based Behavioral Intervention

Behavioral

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.

Primary outcomes

  1. Weight loss

    Time frame: 10 weeks

Secondary outcomes

  1. Loss of Control Eating Scale (LOCES)

    Time frame: 10 weeks

    LOCES measures loss of control eating.

  2. Repetitive Eating Assessment-Questionnaire (Rep(eat))

    Time frame: 10 weeks

    Rep(eat) measures grazing behaviors.

  3. Emotional Eating Scale (EES)

    Time frame: 10 weeks

    EES will be used to measure emotional eating

  4. The Eating Inventory

    Time frame: 10 weeks

    The Eating Inventory will be used to measure disinhibition.

  5. Paffenbarger Physical Activity Recall

    Time frame: 10 weeks

    Paffenbarger will be used to measure physical activity engagement

  6. Philadelphia Mindfulness Scale (PHLMS)

    Time frame: 10 weeks

    PHLMS will be used to measure mindfulness

  7. Drexel Defusion Scale (DDS)

    Time frame: 10 weeks

    DDS will be used to measure delusion (a psychological construct of cognitive distancing)

  8. Food-Related Acceptance and Action Questionnaire (FAAQ)

    Time frame: 10 weeks

    FAAQ will be used to measure food-related acceptance

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 20, 2018
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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