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

58 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Positive Psychology & Motivational Interviewing for Post-Bariatric Surgery?

Research shows that Motivational Interviewing (MI) can help improve patient motivation and adherence to healthy behaviors, which is crucial for post-bariatric surgery success. Studies have demonstrated MI's effectiveness in enhancing readiness for change and adherence to dietary guidelines, which are important for maintaining weight loss after surgery. ^{1 2 3 4 5}

Is Positive Psychology & Motivational Interviewing safe for post-bariatric surgery patients?

Motivational interviewing, a key component of this treatment, is generally considered safe and has been used effectively in various healthcare settings to encourage behavior change without reported safety concerns. ^{1 2 6 7 8}

How is the Positive Psychology-Motivational Interviewing treatment different from other treatments for post-bariatric surgery patients?

The Positive Psychology-Motivational Interviewing (PP-MI) treatment is unique because it combines motivational interviewing, which helps patients find their own motivation to change, with positive psychology, which focuses on enhancing well-being and positive emotions. This approach is different from standard treatments that may not address the psychological and motivational aspects of adhering to post-surgery guidelines. ^{1 2 3 6 9}

What is the purpose of this trial?

This randomized controlled trial examines the feasibility, acceptability, and preliminary impact of an adapted positive psychology-motivational interviewing (PP-MI) intervention for physical activity among patients who have recently undergone bariatric surgery compared to an enhanced usual care control.

Research Team

Emily H Feig, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

References

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

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

2. United States 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. [2018]

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

Motivational interviewing in a family-based pediatric obesity program: a case study. [2021]

4. Ireland 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. [2017]

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

The impact of psychological support on weight loss post weight loss surgery: a randomised control trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Behaviour change in practice: targeting individuals. [2014]

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

Facilitating Behavior Change in Plastic Surgery Patients Who Inject Drugs Through Motivational Interviewing. [2023]

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

Patient and Provider Perceptions About Communication After Bariatric Surgery: A Qualitative Analysis. [2023]

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

The objective of psychological evaluation in the process of qualifying candidates for bariatric surgery. [2007]