N/A
N=58
Gaining Optimism After Weight Loss Surgery (GOALS) II
Bariatric Surgery
Bottom Line
View on ClinicalTrials.gov: NCT04868032 ↗Enrolled (actual)
58
Serious AEs
3.5%
Results posted
Mar 2026
Primary outcome: Primary: Number of Intervention Sessions Completed — 9.6 Sessions completed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Positive Psychology-Motivational Interviewing (Behavioral); Physical Activity Education Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Intervention Sessions Completed |
9.6 | — |
| PRIMARY Intervention Acceptability |
8.5; 8.9; 8.6; 9.0 | — |
| SECONDARY Change in Moderate to Vigorous Physical Activity (MVPA) |
109.47; 110.33; 113.05; 103.46; 125.75; 93.09 | — |
| SECONDARY Change in Steps |
5180.53; 4782.07; 5219.74; 4849.27; 5306.91; 4572.32 | — |
| SECONDARY Change in Light Physical Activity |
253.28; 230.44; 253.86; 232.11; 245.69; 234.66 | — |
| SECONDARY Change in Positive Affect |
34.90; 28.28; 38.38; 30.96; 36.27; 32.15 | — |
| SECONDARY Change in Optimism |
10.28; 11.59; 10.07; 11.73; 10.69; 11.24 | — |
| SECONDARY Change in Depressive Symptoms |
3.34; 5.14; 2.67; 4.19; 3.42; 4.08 | — |
| SECONDARY Change in Anxiety |
6.38; 8; 5.56; 7.77; 5.04; 7.32 | — |
| SECONDARY Change in Exercise Identity |
30.83; 25.03; 41.04; 30.69; 38.19; 28.04 | — |
| SECONDARY Change in General Self-Efficacy |
32.55; 31.76; 34.00; 32.00; 33.65; 31.52 | — |
| SECONDARY Change in Exercise-specific Self-efficacy |
46.52; 45.63; 57.56; 37.00; 50.08; 36.96 | — |
| SECONDARY Change in Internalized Weight Bias |
3.33; 3.56; 2.89; 3.33; 2.58; 3.13 | — |
| SECONDARY Change in Bariatric Surgery-specific Diet and Vitamin Adherence |
44.59; 41.90; 49.44; 42.00; 47.96; 41.04 | — |
| SECONDARY Change in Self-Reported Physical Activity |
1341.31; 771.83; 1719.82; 1424.11; 2358.94; 1309.01 | — |
| SECONDARY Change in Body Mass Index |
35.68; 36.46; 34.40; 36.11; 33.652; 35.91 | — |
| SECONDARY Change in Systolic Blood Pressure (Millimeters of Mercury) |
121.24; 116.55; 123.20; 119.21; 121.75; 120.64 | — |
| SECONDARY Change in Aerobic Capacity and Endurance |
477.20; 482.39; 515.24; 507.68; 511.41; 500.72 | — |
| SECONDARY Change in Body Composition |
47.90; 46.4; 44.97; 44.75; 45.22; 45.28 | — |
| SECONDARY Change in A1C |
5.45; 5.19; 5.43; 5.27; 5.38; 5.36 | — |
| SECONDARY Change in HDL Cholesterol |
53.62; 52.28; 57.88; 56.30; 62.87; 57.88 | — |
| SECONDARY Change in Inflammation |
4.11; 3.80; 2.71; 2.55; 3.07; 2.86 | — |
| SECONDARY Change in Physical Activity Enjoyment |
83.38; 83; 96.85; 89.21; 89.69; 82.76 | — |
| SECONDARY Change in Diastolic Blood Pressure (Millimeters of Mercury) |
69.00; 66.59; 69.12; 71.58; 70.04; 70.84 | — |
| SECONDARY Change in LDL Cholesterol |
105.28; 92.63; 103.96; 97.39; 104.96; 89.48 | — |
| SECONDARY Change in Triglycerides |
102.93; 124.28; 102.72; 113.61; 91.13; 109.36 | — |
Summary
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT04868032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.