Surgical vs. Lifestyle in Obese Older Adults



Status:Active, not recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:55 - 75
Updated:6/21/2018
Start Date:July 1, 2016
End Date:June 30, 2019

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Comparison of Surgical vs. Lifestyle Weight Treatment in Obese Older Adults

The study aims are

1. to demonstrate the feasibility of recruiting and enrolling 10 subjects aged 55-75
planning to undergo sleeve gastrectomy and enrolling 10-20 (1-2 per surgical patient)
matched subjects to the described intensive lifestyle intervention.

2. to collect preliminary data on the comparative effectiveness of the two interventions on
physical function, weight loss, body composition, bone density and QOL.

The investigators propose a 1-year pilot feasibility study to examine the comparative
effectiveness of sleeve gastrectomy compared to an intensive lifestyle intervention of a high
protein low carbohydrate, hypocaloric weight loss diet combined with exercise training among
older adults aged 60-75. For pragmatic and ethical reasons, the investigators are employing a
nonrandomized design. The investigators will recruit 10 older patients undergoing sleeve
gastrectomy and match, recruit, and enroll 1-2 subjects to the lifestyle intervention for
each surgical subject. The investigators will assess physical function, weight loss, body
composition, bone density, QOL and adverse events/health utilization at baseline and 6 and 12
months.

Inclusion Criteria:

- Patients must be aged 55-75 at the time of recruitment,

- speak English,

- meet medical eligibility criteria for WLS (i.e. BMI of >40 or >35 with a major obesity
comorbidity),

- and be willing and able to participate in study procedures including the physical
activity intervention and complete follow-up.

Exclusion Criteria:

The investigators will exclude participants for whom

- intentional weight loss might be inappropriate (e.g. patients with serious
life-limiting illness)

- or who might be psychologically unstable (e.g. moderate to severe depression on the
PHQ-9)

- or who have contraindications to a high protein diet or the physical activity
intervention (e.g. recent MI/CVA in last 6 months, uncontrolled congestive heart
failure, serum creatinine > 2.0 mg/dl/on dialysis, h/o celiac disease/crohn's
disease/ulcerative colitis.)

- or patients whose weight exceeds 450 lbs (weight limit of DXA).

- The investigators will withdraw bariatric subjects who do not undergo weight loss
surgery and his or her matched lifestyle subject. The investigators will withdraw
subjects in the lifestyle group who do not attend at least attend two of the first
three nutrition and physical therapy visits. The investigators will recruit additional
subjects to replace lifestyle subjects who are withdrawn from the study for this
reason.
We found this trial at
1
site
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-754-1402
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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from
Boston, MA
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