N/A
N=50
Pilot Behavioral Support Intervention After Bariatric Surgery
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03092479 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Geisinger Clinic
- Primary completion
- Dec 2017
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 | — |
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.
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.