Behavioral Intervention for Post-Bariatric Surgery Weight Regain

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Temple University

Must not be taking: Weight loss medications

Disqualifiers: Pregnancy, Psychiatric issues, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 23

Duration: 6 months

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not currently use weight loss medications, whether over-the-counter or prescription. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the treatment Acceptance-Based Behavioral Intervention for post-bariatric surgery weight regain?

Research shows that Acceptance and Commitment Therapy (ACT), a component of the Acceptance-Based Behavioral Intervention, can help improve emotional eating, body dissatisfaction, and quality of life in bariatric surgery patients. Studies indicate that ACT enhances psychological flexibility, which is linked to better weight management outcomes after surgery. ^{1 2 3 4 5}

Is Acceptance and Commitment Therapy (ACT) safe for humans?

The studies on Acceptance and Commitment Therapy (ACT) for post-bariatric surgery patients do not report any specific safety concerns, suggesting it is generally safe for humans. Participants in these studies reported benefits such as improved emotional eating behaviors and quality of life. ^{1 2 3 4 5}

How is the Acceptance-Based Behavioral Intervention (ABBT) treatment different from other treatments for weight regain after bariatric surgery?

The Acceptance-Based Behavioral Intervention (ABBT) is unique because it focuses on psychological flexibility, helping patients accept difficult feelings and thoughts while engaging in healthy activities, which is not typically addressed by other treatments. This approach aims to improve outcomes by targeting emotional eating and body dissatisfaction, which are common challenges after bariatric surgery. ^{1 3 4 5 6}

What is the purpose of this trial?

The goal of this clinical trial is to test the effectiveness of remotely-delivered interventions (utilizing acceptance-based behavioral treatment skills (ABTi)) amongst bariatric surgery populations who are experiencing weight regain postoperatively (\> 5% from their lowest postoperative weight and after postoperative Month 6). Investigators aim to evaluate ABTi's efficacy for reversing weight regain and its effect on targeted weight control behaviors and weight-related comorbidities by comparing participants randomly assigned ABTi (n = 100) to those assigned to a Control group that also receives brief phone calls but that focus on reiterating instruction on the dietary and behavioral changes required of surgery and initially taught preoperatively (C, n = 100). The main research aims are: 1. To compare changes in body weight over 12 months in 200 bariatric patients who have regained \> 5% of their weight and are randomly assigned to ABTi or Control. 2. To compare changes in eating behaviors (i.e., caloric intake, frequency of maladaptive eating behaviors), physical activity, and weight-related comorbidities (i.e., biomarkers of diabetes, hypertension) over 12 months in the two groups. 3. Exploratory - To test ABTi's theoretical mechanisms of action, including a) effects of theory-based active ingredients (i.e., acceptance, defusion, values clarity, mindfulness) on weight outcomes and b) changes in impact of internal states (i.e., hunger, cravings) on eating behavior.

Eligibility Criteria

This trial is for individuals who have had bariatric surgery, are experiencing weight regain of more than 5% after the sixth postoperative month, and want to try a remotely-delivered behavioral treatment. It's not suitable for those who don't meet these specific conditions.

Inclusion Criteria

I am either a man or a woman.

Ability to give consent

Ability to speak, write, and understand English

Exclusion Criteria

I am on long-term oral steroid medication.

Current, self-reported use of tobacco products

I am currently taking medication to lose weight.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remotely delivered interventions using acceptance-based behavioral treatment skills (ABTi) or Control intervention over 6 months

6 months

20 modules with weekly self-monitoring and brief calls

Follow-up

Participants are monitored for changes in body weight, eating behaviors, physical activity, and weight-related comorbidities

12 months

Assessment points at baseline, 3 Month, 6 Month, 12 Month

Treatment Details

Interventions

• Acceptance-Based Behavioral Intervention

Trial Overview The study tests an acceptance-based behavioral intervention (ABTi) against standard post-surgery advice in controlling weight regain over 12 months. Participants will be randomly placed into two groups: one receiving ABTi and the other receiving regular dietary and behavior guidance calls.

Participant Groups

Group I: Acceptance-Based Behavioral Intervention Experimental Treatment 1 Intervention

Participants assigned to ABTi will receive a remotely delivered intervention consisting of 20 modules over 6 months. Based on theory derived from acceptance and mindfulness approaches, the intervention provides psychological strategies to facilitate engagement in weight control behaviors. Each module includes a video presentation of material synchronized with a slideshow illustrating session material, interactive features, quizzes that will ensure participants have mastered the material, and directed assignments to be completed throughout the week. Participants will be assigned to view each module, self-monitor their daily food intake, and weigh themselves weekly. At the completion of each module, a brief call with a coach will be scheduled to discuss and clarify the content of the session, review homework, and provide feedback on food records and weekly weights.

Group II: Control Active Control 1 Intervention

Participants assigned to the Control condition will receive telephone contacts from the coaches on the same schedule as those who receive ABTi. The content will focus on the (re) delivery of the dietary and behavioral instruction that patients received prior to bariatric surgery. For example, participants will be reminded to consume reduced portion sizes, avoid foods higher in sugar and fat, and eat discrete meals throughout the day. They will receive a Wi-Fi scale and will be asked to weigh themselves weekly, similar to those receiving ABTi.

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials

321

Recruited

89,100+

Rush University

Collaborator

Trials

46

Recruited

3,294,000+

Findings from Research

A randomized controlled trial involving 80 participants tested Acceptance and Commitment Therapy (ACT) after bariatric surgery, but attendance was low, with only 29% of ACT participants completing more than half of the sessions.

Despite the low attendance, participants who did attend the ACT groups reported benefits such as behavior change, indicating that while the intervention was not well accepted in its current format, it has potential if delivery methods are improved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing a critical need: A randomised controlled feasibility trial of acceptance and commitment therapy for bariatric surgery patients at 15-18 months post-surgery. Barley, EA., Bovell, M., Bennett-Eastley, K., et al.[2023]

This randomized controlled trial will involve 480 adults with overweight or obesity, assessing the effectiveness of two low-contact weight loss maintenance interventions based on Acceptance and Commitment Therapy (ACT) and self-regulation (SR) after an initial 3-month weight loss program.

The primary outcome will be weight change over 30 months post-randomization, allowing for a comprehensive evaluation of the long-term efficacy of these interventions in preventing weight regain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a randomized controlled trial comparing two low-intensity weight loss maintenance interventions based on acceptance and commitment therapy or self-regulation. Lillis, J., Schumacher, L., Thomas, JG., et al.[2022]

A 10-week acceptance-based behavioral intervention for bariatric surgery patients showed feasibility and acceptability, with 72% retention and high satisfaction ratings (4.25 out of 5).

The intervention effectively stopped and even reversed weight regain, resulting in an average weight loss of 3.58% among participants who had previously regained at least 10% of their maximum lost weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of an Acceptance-Based Behavioral Intervention for Weight Regain After Bariatric Surgery. Bradley, LE., Forman, EM., Kerrigan, SG., et al.[2018]

A study involving 39 participants showed that Acceptance and Commitment Therapy (ACT) significantly improved psychological outcomes such as body dissatisfaction and quality of life after bariatric surgery, compared to treatment as usual (TAU).

The improvements in body dissatisfaction and quality of life were linked to increased psychological flexibility, suggesting that incorporating psychological interventions like ACT can enhance the overall effectiveness of bariatric surgery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological flexibility and the gains of acceptance-based treatment for post-bariatric surgery: six-month follow-up and a test of the underlying model. Weineland, S., Hayes, SC., Dahl, J.[2015]

A randomized controlled trial with 39 participants demonstrated that acceptance and commitment therapy (ACT) significantly improved emotional eating behaviors, body dissatisfaction, and quality of life in patients who underwent bariatric surgery compared to standard follow-up care.

The study suggests that addressing emotional eating through ACT can enhance the long-term effectiveness of bariatric surgery, which is crucial since 20-30% of patients tend to regain weight within 24 months post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy for bariatric surgery patients, a pilot RCT. Weineland, S., Arvidsson, D., Kakoulidis, TP., et al.[2014]

Weight regain after bariatric surgery is often linked to problematic eating behaviors, including driven overeating, which is characterized by a loss of control over eating and can lead to overeating.

The review suggests that addressing emotional and reward-based eating, along with impulsivity, through tailored treatment strategies may help patients manage increased hunger and cravings, potentially reducing weight regain after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Interventions to Attenuate Driven Overeating and Weight Regain After Bariatric Surgery. Ames, GE., Koball, AM., Clark, MM.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Addressing a critical need: A randomised controlled feasibility trial of acceptance and commitment therapy for bariatric surgery patients at 15-18 months post-surgery. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Study protocol for a randomized controlled trial comparing two low-intensity weight loss maintenance interventions based on acceptance and commitment therapy or self-regulation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A Pilot Study of an Acceptance-Based Behavioral Intervention for Weight Regain After Bariatric Surgery. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Psychological flexibility and the gains of acceptance-based treatment for post-bariatric surgery: six-month follow-up and a test of the underlying model. [2015]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy for bariatric surgery patients, a pilot RCT. [2014]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Behavioral Interventions to Attenuate Driven Overeating and Weight Regain After Bariatric Surgery. [2022]