N/A
N=12
Gaining Optimism After Weight Loss Surgery (GOALS) I
Bariatric Surgery
Bottom Line
View on ClinicalTrials.gov: NCT04867902 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Number of Intervention Sessions Completed — 8.5 sessions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Positive Psychology-Motivational Interviewing Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Intervention Sessions Completed |
8.5 | — |
| PRIMARY Ease and Utility of Intervention Sessions |
8.3; 8.7; 8.8; 8.7 | — |
| SECONDARY Change in Moderate to Vigorous Physical Activity (MVPA) |
105.0; 223.4 | — |
| SECONDARY Change in Steps |
5008.8; 6544.9 | — |
| SECONDARY Change in Light Physical Activity |
1767.6; 1786.5 | — |
| SECONDARY Change in Sedentary Time |
691.63; 743.71 | — |
| SECONDARY Change in Optimism |
11.3; 11.4 | — |
| SECONDARY Change in Depressive Symptoms |
5.0; 3.0 | — |
| SECONDARY Change in Anxiety |
7.5; 4.7 | — |
| SECONDARY Change in Motivation to Change |
10.39; 10.36 | — |
| SECONDARY Change in Exercise Identity |
26.6; 39.9 | — |
| SECONDARY Change in General Self-Efficacy |
32.5; 34.6 | — |
| SECONDARY Change in Exercise-specific Self-efficacy |
44.6; 55.3 | — |
| SECONDARY Change in Internalized Weight Bias |
4.0; 3.2 | — |
| SECONDARY Change in Body Image |
2.42; 3.26 | — |
| SECONDARY Change in Bariatric Surgery-specific Diet and Vitamin Adherence |
41.7; 46.0 | — |
| SECONDARY Change in Self-Reported Physical Activity |
11.25; 44.02 | — |
| SECONDARY Change in Body Weight |
257.95; 199.83 | — |
| SECONDARY Change in Waist Circumference (in Centimeters) |
114.4; 102.2 | — |
| SECONDARY Change in Systolic Blood Pressure |
116.83; 117.83 | — |
| SECONDARY Change in Aerobic Capacity and Endurance |
494.7; 583.2 | — |
| SECONDARY Change in Social Support for Exercise |
42.92; 54.33 | — |
| SECONDARY Change in Social Support for Eating Habits - Encouragement Subscale |
24.92; 26.17 | — |
| SECONDARY Change in Body Composition |
40.1; 39.1 | — |
| SECONDARY Change in A1C |
5.19; 5.25 | — |
| SECONDARY Change in High-density Lipoprotein (HDL) |
50.58; 56.33 | — |
| SECONDARY Change in Inflammation |
3.47; 4.17 | — |
Summary
This study 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.
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.
Data sourced from ClinicalTrials.gov (NCT04867902). 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.