Surgical vs. Lifestyle in Obese Older Adults

Stopped early · Not applicable

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT03137329

Run by

Beth Israel Deaconess Medical Center

People needed

2

Starts

2016-07-01

Expected to finish

2019-06-28

Last updated by the study team

2019-07-23

Who can join

Age: 55 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 The investigators will recruit additional subjects to replace lifestyle subjects who are withdrawn from the study for this reason.

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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