N/A
Completed N=50
Pilot Behavioral Support Intervention After Bariatric Surgery
Source: ClinicalTrials.gov NCT03092479 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Difference in Mean Health-Related Quality of Life (HRQoL) Scores Related to Physical Function, Energy Level and General Health. — 11.4; 4.6 score on a scale
Summary
Prospective, randomized pilot trial to evaluate a comprehensive postoperative behavioral support intervention using a 4-month bi-weekly program in 40 bariatric surgery patients (all surgical procedure types) from the Geisinger Health System Center for Nutrition and Weight Management compared to 40 usual care patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Mean Health-Related Quality of Life (HRQoL) Scores Related to Physical Function, Energy Level and General Health. |
11.4; 4.6 | — |
| SECONDARY Difference Between Groups in Depression Scores. |
-0.9; -1.1 | — |
| SECONDARY Difference Between Groups in Anxiety Scores. |
0.9; 0.3; -1.5; -0.4 | — |
| SECONDARY Difference Between Groups in Measured Self-efficacy. |
2.0; -1.6 | — |
| SECONDARY Difference in Physical Activity Levels Between Groups. |
71; -14 | — |
| SECONDARY Difference in Emotional Eating Scale Results Between Groups. |
1.5; 0.1; -0.4; 1.9; 1.5; 0.0 | — |
| SECONDARY Differences Between Groups in Loss of Eating Control. |
0.1; -0.7 | — |
Eligibility Criteria
Inclusion Criteria
- BMI>35 kg/m2 at time of surgery
- Primary bariatric surgery completion < 1 year
- Understanding of informed consent
Exclusion Criteria
- Pregnancy
- Revision of bariatric surgery
- Significant cognitive impairment that prevents informed consent
Data sourced from ClinicalTrials.gov (NCT03092479). 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. Informational only — not medical advice.