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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK077102 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of the trial is to determine whether a preoperative lifestyle intervention (targeting diet, exercise, and preparation for surgery) will favorably impact obesity-related parameters prior to bariatric surgery and improve short-term postoperative outcomes.
This is a randomized, controlled trial to evaluate the impact of a preoperative lifestyle intervention that targets diet, exercise, and preparation for surgery as an adjunct to the surgical treatment of obesity. Patients will be randomized to a 6-month lifestyle intervention (n = 100) or to usual care (n = 100) prior to undergoing bariatric surgery. We aim to evaluate the effect of the intervention on select pre- and postoperative outcomes. We hypothesize that patients who participate in the preoperative intervention will exhibit greater improvements in weight and related outcomes and better preparation for surgery than those who receive usual care. After operation, we hypothesize that patients who participate in the intervention will exhibit better compliance and fewer behavior-related eating problems, as well as a lower rate of complications and fewer outpatient visits with surgery-related conditions than those who received usual preoperative care. Our secondary aim is to determine whether the intervention affects weight/BMI trajectory through 24 months after operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Usual preoperative care | |
| 2 | Experimental | Preoperative Lifestyle Intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative lifestyle Intervention | Behavioral | 6 month individual intervention consisting of weekly face-to-face and telephone sessions addressing diet, activity and preparation for surgery, followed by 3 "booster" telephone calls after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| weight and related outcomes (BMI, cardiovascular risk, quality of life) | pre and post intervention | |
| preparation for surgery (eating, activity and knowledge of surgery) | pre and post intervention | |
| compliance and eating problems (vomiting, dumping, plugging etc.) | 6- and 12-months post surgery | |
| surgical complications and outpatient visits | 6- and 12-months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Weight/BMI trajectory | pre- and post-intervention; 6-, 12 and 24 months postop |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa A Kalarchian, PhD | Duquesne University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duquesne University | Pittsburgh | Pennsylvania | 15282 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25443069 | Derived | Kalarchian MA, Marcus MD, Courcoulas AP, Cheng Y, Levine MD. Self-report of gastrointestinal side effects after bariatric surgery. Surg Obes Relat Dis. 2014 Nov-Dec;10(6):1202-7. doi: 10.1016/j.soard.2014.08.007. Epub 2014 Aug 23. |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |