Improving physical activity after weight loss surgery
Gaining Optimism After Weight Loss Surgery (GOALS) II: Randomized Controlled Trial of a Positive Psychology-based Intervention to Increase Physical Activity After Bariatric Surgery
This study is testing a new program that combines motivational support and a Fitbit to help people who have had weight loss surgery become more active.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04868032 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates the feasibility and acceptability of a positive psychology-motivational interviewing (PP-MI) intervention aimed at promoting physical activity among patients who have recently undergone bariatric surgery. Participants will be randomly assigned to either a 10-week intervention that includes weekly phone calls, a written manual, and a Fitbit activity tracker, or to a control group receiving only the Fitbit. The study will assess primary outcomes related to the intervention's feasibility and acceptability, as well as secondary outcomes including changes in physical activity and psychological, behavioral, and physiological measures at 10 and 24 weeks. A total of 58 participants will be enrolled from two academic medical centers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone bariatric surgery within the past 6-12 months and are interested in increasing their physical activity.
Not a fit: Patients with severe cognitive deficits, illnesses likely to lead to death in the next 6 months, or those unable to engage in physical activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance physical activity levels and overall well-being in patients post-bariatric surgery.
How similar studies have performed: Other studies have shown promise in using motivational interviewing and positive psychology approaches to improve health outcomes, suggesting potential success for this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (age 18+) * History of bariatric surgery (gastric bypass or sleeve gastrectomy) at one of two academic medical centers within the past 6-12 months * Interest in increasing physical activity * Low physical activity, defined as \<200 minutes/week self-reported moderate- to-vigorous physical activity * Access to telephone for study sessions * Able to read and speak English Exclusion Criteria: * Cognitive deficits precluding participation or informed consent * Illness likely to lead to death in the next 6 months * Inability to be physically active (e.g., severe arthritis) * Participation in another program targeting physical activity besides their standard offerings at the surgery center. * Severe psychiatric condition limiting ability to participate (e.g., psychosis, active substance use disorder)
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Emily H Feig, PhD — Massachusetts General Hospital
- Study coordinator: Emily H Feig, PhD
- Email: efeig@mgh.harvard.edu
- Phone: 617-724-9140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.