NCT03137329

Surgical vs. Lifestyle in Obese Older Adults

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Exercise program	Physical therapy for aerobic and resistance training exercises
DIETARY_SUPPLEMENT	Nutrition	Nutrition supplementation via HMR for lifestyle arm only
PROCEDURE	WLS	Weight loss surgery as planned

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-06-28
• Completion: 2019-06-28
• First posted: 2017-05-02
• Last updated: 2019-07-23

Locations

1 site across 1 country: United States