Positive Psychology & Motivational Interviewing for Post-Bariatric Surgery

(GOALS Trial)

Overseen By Emily H Feig, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Cognitive deficits, Severe psychiatric condition, others

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

Compensation: Varies

Number of Visits: 4

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a combination of positive psychology and motivational interviewing, known as Positive Psychology-Motivational Interviewing, can increase physical activity in individuals who have undergone bariatric surgery. The study compares this approach to a control group receiving general physical activity information and a Fitbit. Ideal participants are adults who had bariatric surgery 6-12 months ago, wish to become more active, and currently engage in less than 200 minutes of moderate to intense exercise weekly. Participants should also be comfortable using a phone and speaking English to join the sessions. As an unphased trial, this study provides a unique opportunity to explore innovative methods to enhance physical activity post-surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

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

Research has shown that positive psychology and motivational interviewing (MI) are safe and well-received. In past studies, participants attended 85% of the sessions, indicating that this approach is both feasible and liked. People rated the sessions highly, with scores over 8 out of 10 for being helpful and easy to understand, suggesting that most found the sessions useful and simple to follow.

Motivational interviewing is particularly known for its supportive and non-judgmental nature. It aims to increase motivation without being pushy or making participants feel uncomfortable, creating a welcoming environment.

No major negative side effects were reported, making the combination of positive psychology and motivational interviewing a promising choice for those seeking to become more active after bariatric surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Positive Psychology and Motivational Interviewing for post-bariatric surgery patients because this approach focuses on enhancing mental well-being and motivation, rather than just physical recovery. Unlike traditional post-surgery care that often emphasizes physical exercise through general recommendations, this method incorporates psychological skills to boost positive emotions and motivation during physical activity. Additionally, the use of a Fitbit to set personalized activity goals makes the approach highly individualized, aiming to improve adherence and long-term success in maintaining a healthy lifestyle. This mental and motivational focus offers a fresh perspective that could significantly enhance patient outcomes beyond what standard care achieves.

What evidence suggests that this trial's treatments could be effective for post-bariatric surgery patients?

Research has shown that combining positive thinking with motivational conversations can help individuals who have undergone weight-loss surgery become more active. In this trial, participants in the Positive Psychology-Motivational Interviewing Intervention arm will engage in these activities. Studies indicate that these methods can lead to better control over eating habits and adherence to healthy routines. Specifically, participants in similar activities reported fewer binge eating episodes and better diet adherence over 12 weeks. Additionally, focusing on positive feelings may help patients overcome emotional challenges, making it easier to stay active and maintain weight loss. Overall, this approach could increase motivation and support long-term health improvements after surgery. ^{3 6 7 8 9}

Who Is on the Research Team?

Emily H Feig, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak English and had bariatric surgery (gastric bypass or sleeve gastrectomy) at one of two medical centers in the last 6-12 months. They should have low physical activity, want to be more active, and can talk on the phone for study sessions. People with severe mental health issues, life-threatening illnesses, or other physical activity programs are excluded.

Inclusion Criteria

I had weight loss surgery at a major hospital within the last year.

You are willing to participate in activities that increase your physical activity.

Access to telephone for study sessions

Exclusion Criteria

I cannot be physically active due to a condition like severe arthritis.

You cannot participate in any other physical activity program besides the ones offered at the surgery center.

You have a serious mental health condition that could prevent you from joining the study, such as psychosis or current drug addiction.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 10-week physical activity intervention with weekly phone calls, a written manual, and a Fitbit activity tracker, or a Fitbit alone with educational materials.

10 weeks

4 visits (2 at baseline, 1 at 10 weeks, 1 at 24 weeks)

Follow-up

Participants are monitored for changes in physical activity and other outcomes at 10 and 24 weeks.

14 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Usual Care Control
• Physical Activity Education Control
• Positive Psychology-Motivational Interviewing

Trial Overview

The GOALS II trial is testing a program that combines positive psychology with motivational interviewing to encourage physical activity after weight loss surgery. It's compared against enhanced usual care control to see if it's feasible, acceptable, and effective.

How Is the Trial Designed?

Group I: Positive Psychology-Motivational Interviewing Intervention Experimental Treatment 1 Intervention

Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.

Group II: Physical Activity Education Control Active Control 1 Intervention

Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The pilot study involving 51 post-operative bariatric patients showed that Adapted Motivational Interviewing (AMI) significantly improved patients' readiness for change, self-efficacy, and dietary adherence immediately after the intervention.

Participants who received AMI reported better outcomes in binge eating symptoms and dietary adherence over a 12-week follow-up compared to those in the wait-list control group, indicating that AMI may be a promising approach to enhance post-surgical dietary compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial examining the feasibility, acceptability, and efficacy of Adapted Motivational Interviewing for post-operative bariatric surgery patients. David, LA., Sockalingam, S., Wnuk, S., et al.[2018]

Effective communication between patients and providers is crucial for influencing weight-related behaviors after bariatric surgery, as highlighted by interviews with 45 participants, including 24 patients and various healthcare providers.

Patients from socioeconomically disadvantaged backgrounds often feel less trust towards providers and require more effort in rapport-building, indicating that personalized communication and reassurance are key to improving postoperative care and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Provider Perceptions About Communication After Bariatric Surgery: A Qualitative Analysis. Lam, CS., Alagoz, E., Jawara, D., et al.[2023]

Motivational interviewing techniques, originally developed for addiction treatment, can be effectively applied to medical consultations for behavior change, particularly in managing obesity.

The paper outlines four clinical strategies that encourage patient engagement during consultations, helping practitioners provide more effective advice and avoid common pitfalls in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behaviour change in practice: targeting individuals. Rollnick, S.[2014]

Motivational Interviewing (MI) was successfully integrated into a family-based, multidisciplinary weight management program for a 14-year-old girl, demonstrating its potential effectiveness in treating obesity.

Further research is needed to explore how MI can be applied in various care teams, including the necessary training frequency and its feasibility in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing in a family-based pediatric obesity program: a case study. Irby, M., Kaplan, S., Garner-Edwards, D., et al.[2021]

Motivational interviewing is an effective, evidence-based technique that helps patients with upper limb issues from intravenous drug use to change their unhealthy behaviors, leading to better health outcomes.

The authors emphasize that plastic surgeons should be trained in motivational interviewing to support patients in their journey towards behavior change, as it can be applied effectively even in brief clinical encounters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating Behavior Change in Plastic Surgery Patients Who Inject Drugs Through Motivational Interviewing. Olaiya, O., Alagabi, A., Igboanugo, S., et al.[2023]

Training all clinic staff in motivational interviewing (MI) through a coaching model led to improved clinician satisfaction, reduced burnout, and enhanced self-rated MI skills among staff in intervention clinics, compared to control clinics.

Patient satisfaction significantly increased in the clinics where staff received MI training, indicating that this approach can positively impact both clinician and patient experiences in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of teaching motivational interviewing via communication coaching on clinician and patient satisfaction in primary care and pediatric obesity-focused offices. Pollak, KI., Nagy, P., Bigger, J., et al.[2017]

A psychological evaluation is crucial for patients undergoing bariatric surgery, as it helps identify psychosocial factors that could affect treatment outcomes.

In a study involving 80 patients, clinical interviews revealed key elements that should be assessed to provide effective psychological support before and after surgery, enhancing the overall treatment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The objective of psychological evaluation in the process of qualifying candidates for bariatric surgery. Dziurowicz-Kozlowska, AH., Wierzbicki, Z., Lisik, W., et al.[2007]

In a study involving 162 patients undergoing Roux-en-Y gastric bypass, the addition of a health psychology-led bariatric rehabilitation service (BRS) did not significantly improve weight loss outcomes at 1 year compared to standard treatment.

Both groups experienced similar reductions in BMI, with an average change of approximately -16.5, suggesting that psychological support may be more beneficial for patients who begin to regain weight after surgery rather than as a routine pre- and post-operative intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of psychological support on weight loss post weight loss surgery: a randomised control trial. Ogden, J., Hollywood, A., Pring, C.[2022]

Nonadherence to healthy habits is common in adults at risk for lifestyle diseases and those undergoing bariatric surgery, which can lead to poor outcomes post-surgery.

Motivational interviewing is an effective counseling technique that can enhance patient motivation and adherence to behavioral recommendations by addressing ambivalence and improving clinician-patient communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Why won't my patients do what's good for them?" Motivational interviewing and treatment adherence. Zuckoff, A.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9585441/

A Positive Emotion–Focused Intervention to Increase ...

Physical activity interventions that include positive psychology may be particularly effective after bariatric surgery. In addition to improving overall well- ...

2.

withpower.com

withpower.com/trial/positive-psychology-motivational-interviewing-for-post-bariatric-surgery-3a5b0

Positive Psychology & Motivational Interviewing for Post- ...

Participants who received AMI reported better outcomes in binge eating symptoms and dietary adherence over a 12-week follow-up compared to those in the wait- ...

3.

sciencedirect.com

sciencedirect.com/science/article/am/pii/S1077722923000342

Using Positive Psychology to Address Emotional Barriers ...

POSITIVE PSYCHOLOGY FOR PHYSICAL ACTIVITY POST-BARIATRIC SURGERY 18. Results. Baseline Data. Recruitment and retention information is provided in Figure 3. All ...

4.

ahajournals.org

ahajournals.org/doi/10.1161/circ.147.suppl_1.MP70

Abstract MP70: Proof-of-Concept Trial of a Positive ...

We tested feasibility, acceptability, and pre-post change in PA and psychological, behavioral, and physiological outcomes in a single-arm proof- ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36201380/

Protocol for a Pilot Randomized Controlled Trial

Positive psychological well-being is associated with improved adherence to health behaviors, but bariatric surgery patients often have negative ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11052544/

Using Positive Psychology to Address Emotional Barriers to ...

Results showed that the intervention was feasible (85% of sessions completed) and acceptable (average participant ratings of session ease and utility above 8.0 ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1077722923000342

Proof-of-Concept Trial of the Gaining Optimism After ...

Results showed that the intervention was feasible (85% of sessions completed) and acceptable (average participant ratings of session ease and utility above 8.0 ...

8.

researchprotocols.org

researchprotocols.org/2022/10/e39856/

A Positive Emotion–Focused Intervention to Increase ...

Positive psychological well-being is associated with improved adherence to health behaviors, but bariatric surgery patients often have negative ...

9.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1002/osp4.70057

Motivational Interviewing (MI) in Obesity Care: Cultivating ...

Motivational interviewing (MI) has the potential to transform clinical interactions by using non-stigmatizing language, communication, and ...