Behavioral Intervention for Post-Bariatric Surgery Weight Regain

Recruiting at 1 trial location

Overseen By Sarah R Fischbach, MPH

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals who have regained more than 5% of their weight after bariatric surgery. It tests a remote program called Acceptance-Based Behavioral Intervention (ABTi), which includes videos, quizzes, and coaching calls to promote healthy eating and exercise habits. Researchers will compare participants to a control group receiving reminders about dietary and behavioral strategies taught before surgery. The trial seeks individuals who underwent gastric bypass or sleeve surgery 6 to 48 months ago, regained some weight, and are not currently taking weight loss medication.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve post-surgery weight management strategies.

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 prior data suggests that this behavioral intervention is safe for post-bariatric surgery patients?

Research has shown that treatments focused on acceptance, like the one in this trial, are generally safe. Studies have found that participants can easily handle this type of treatment. For instance, a small study with patients who regained weight after weight-loss surgery showed they could undergo the treatment without major problems. This method often includes activities like mindfulness and acceptance, which have been linked to improved quality of life without serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard post-bariatric surgery treatments that often focus on repeating dietary and behavioral instructions, the Acceptance-Based Behavioral Intervention (ABTi) offers a fresh approach by incorporating acceptance and mindfulness strategies. These methods are designed to help patients engage more effectively in weight control behaviors. Delivered remotely through 20 interactive modules, this intervention not only educates but also actively involves participants with quizzes, assignments, and weekly feedback sessions with a coach. Researchers are excited about ABTi because it leverages psychological strategies to potentially offer more sustainable weight management solutions.

What evidence suggests that this trial's interventions could be effective for post-bariatric surgery weight regain?

Research has shown that certain behavioral treatments can help manage weight gain after bariatric surgery. In this trial, participants will join one of two groups. One group will receive the Acceptance-Based Behavioral Intervention, which includes acceptance and commitment therapy to help patients accept their feelings and commit to healthy habits. This approach uses psychological strategies like mindfulness to aid patients in making better choices about eating and exercise. The other group, the Control condition, will receive dietary and behavioral instruction similar to what they received before bariatric surgery. Overall, these methods have shown promise in helping maintain weight loss after bariatric surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

David B Sarwer, PhD

Principal Investigator

Temple University

Are You a Good Fit for This Trial?

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

Current, self-reported use of tobacco products

I am on long-term oral steroid medication.

I am currently taking medication to lose weight.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26964997/

A Pilot Study of an Acceptance-Based Behavioral ... Methods: A sample of bariatric surgery patients (n = 11) who regained at least 10 % of their maximum lost postoperative weight was recruited. All participants ...

2. drexel.edu drexel.edu/~/media/Files/coas2/psychology/innovation-lab/Bradley%202016%20Obesity%20Surgery.ashx

A Pilot Study of an Acceptance-Based Behavioral ... Conclusions These findings provide initial support for the use of a psychological acceptance-based intervention for weight regain in bariatric surgery patients.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1871403X1100024X

Acceptance and commitment therapy for bariatric surgery ... While BS interventions result in significant long-term weight loss, 20–30% of patients regain some weight within 24 months following surgery [15], [16], [17], [ ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0282849

A randomised controlled feasibility trial of acceptance and ... However, around one in five people experience significant weight regain. Acceptance and Commitment Therapy (ACT) teaches acceptance of and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4472472/

Acceptance-based behavioral treatment for weight control In this paper we review the rationale for utilizing ABBT for weight control and the current research evaluating its effectiveness.

6. researchgate.net researchgate.net/publication/297746534_A_Pilot_Study_of_an_Acceptance-Based_Behavioral_Intervention_for_Weight_Regain_After_Bariatric_Surgery

(PDF) A Pilot Study of an Acceptance-Based Behavioral ... Methods A sample of bariatric surgery patients (n = 11) who regained at least 10 % of their maximum lost postoperative weight was recruited. All ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2212144724001078

An acceptance and commitment therapy and mindfulness ... This study suggests that an ACT and mindfulness-based group intervention could produce improvements in the impact of weight on quality of life.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10128967/

A randomised controlled feasibility trial of acceptance and ... Bariatric surgery is an effective treatment for obesity. However, around one in five people experience significant weight regain. Acceptance and Commitment ...