Pilot Behavioral Support Intervention After Bariatric Surgery
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/6/2018 |
| Start Date: | January 20, 2017 |
| End Date: | December 22, 2017 |
A Randomized Trial of a Pilot Behavioral Support Intervention After Bariatric Surgery
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.
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.
Bariatric surgery patients may experience significant psychosocial changes after surgery, but
little psychological support is available beyond support groups postoperatively. Psychosocial
changes after surgery, including mood fluctuations, interpersonal issues and substance use,
have the potential to lower quality of life and interfere with adherence to the postoperative
diet and lifestyle, diminishing weight loss outcomes.
This prospective randomized pilot trial will evaluate the effect of a postoperative support
program targeting quality of life, psychosocial functioning and adherence to behavior change
in Geisinger Health System (GHS) bariatric surgery patients.
In this study there will be two arms. The intervention arm will include forty bariatric
surgery patients (all procedure types) from the GHS Center for Nutrition and Weight
Management (CNWM) who will participate in a four month bi-weekly postoperative behavioral
support program to address psychosocial changes after surgery, strategies for postoperative
diet and adherence and preventing weight regain. The control arm will include 40 usual care
(UC) patients from the same center that completed bariatric surgery within one year.
Both groups will complete two sets of surveys. The first set will be administered at study
initiation. The second set will be administered upon completion of the 8 sessions for the
intervention group. The control group will also complete surveys during this same timeframe
(approximately 4-6 months after baseline survey completion).
Upon study completion, control group members will be afforded an opportunity to participate
in the same postoperative behavioral support program offered to the intervention group.
The primary endpoint of this study will be quality of life with secondary endpoints including
differences in psychosocial functioning (mood, eating behaviors) and adherence (diet,
physical activity, appointments) as well as patient satisfaction, treatment feasibility and
attrition.
little psychological support is available beyond support groups postoperatively. Psychosocial
changes after surgery, including mood fluctuations, interpersonal issues and substance use,
have the potential to lower quality of life and interfere with adherence to the postoperative
diet and lifestyle, diminishing weight loss outcomes.
This prospective randomized pilot trial will evaluate the effect of a postoperative support
program targeting quality of life, psychosocial functioning and adherence to behavior change
in Geisinger Health System (GHS) bariatric surgery patients.
In this study there will be two arms. The intervention arm will include forty bariatric
surgery patients (all procedure types) from the GHS Center for Nutrition and Weight
Management (CNWM) who will participate in a four month bi-weekly postoperative behavioral
support program to address psychosocial changes after surgery, strategies for postoperative
diet and adherence and preventing weight regain. The control arm will include 40 usual care
(UC) patients from the same center that completed bariatric surgery within one year.
Both groups will complete two sets of surveys. The first set will be administered at study
initiation. The second set will be administered upon completion of the 8 sessions for the
intervention group. The control group will also complete surveys during this same timeframe
(approximately 4-6 months after baseline survey completion).
Upon study completion, control group members will be afforded an opportunity to participate
in the same postoperative behavioral support program offered to the intervention group.
The primary endpoint of this study will be quality of life with secondary endpoints including
differences in psychosocial functioning (mood, eating behaviors) and adherence (diet,
physical activity, appointments) as well as patient satisfaction, treatment feasibility and
attrition.
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
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