Obesity Clinical Trial - Surgical vs. Lifestyle in Obese Older Adults

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Obesity

Clinical Trial Details

NCT number	NCT03137329
Study type	Interventional
Source	Beth Israel Deaconess Medical Center
Contact
Status	Terminated
Phase	N/A
Start date	July 1, 2016
Completion date	June 28, 2019

View Details

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