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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Physical therapy for aerobic and resistance training exercises
Nutrition supplementation via HMR for lifestyle arm only
Weight loss surgery as planned
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Change in Physical Function
The primary outcome will be change in physical function as measured change in score on the Short Physical Performance Battery (SPPB) between the two groups at 6 months and 12 months. Secondary physical function outcomes includes change in performance on the Timed 400m walk and the sum of the one-repetition maximal weight subjects are able to lift in the biceps curl, bench press, seated row, knee extension and flexion, and leg press.\[
Time frame: Years 1 and 2
Change in anthropometric measurements-body weight
Changes in: body weight
Time frame: Years 1 and 2
Change in anthropometric measurements-waist circumference
Changes in: waist circumference
Time frame: Years 1 and 2
Change in body composition
Change in: fat mass, lean body mass of the whole body
Time frame: Years 1 and 2
Change in bone mineral density
Change in: bone density at the total hip and radius as measured by dual energy x-ray absorptiometry (DEXA) among subjects who weigh up to 450 lbs (equipment weight limit)
Time frame: Years 1 and 2
Change in blood pressure
Change in: blood pressure
Time frame: Years 1 and 2
Change in biochemical assessments-hbA1C
Change in: hemoglobin A1c,
Time frame: Years 1 and 2
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Change in biochemical assessments-insulin and glucose
Change in: insulin and fasting glucose (insulin resistance)
Time frame: Years 1 and 2
Change in biochemical assessments-bone and muscle metabolism
Change in: biomarkers related to bone and muscle metabolism including vitamin D and bone alkaline phosphatase
Time frame: Years 1 and 2
Change in quality of life
Change in: Quality of life scores as measured by the Impact of Weight on Quality of Life and the Short Form-36
Time frame: Years 1 and 2
Change in pain
Change in: pain score using the Brief Pain Inventory
Time frame: Years 1 and 2
Change in disability
Change in: difficulty performing ADLs and IADLs
Time frame: Years 1 and 2
Change in medical history, medications and healthcare utilization from adverse events
all visits, hospitalizations, and emergency room visits including any study related visits.
Time frame: Years 1 and 2