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Surgical vs. Lifestyle in Obese Older Adults

NCT03137329 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-07-23

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Christina C Wee, MD, MPH · Beth Israel Deaconess Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2019-06-28
Completion
2019-06-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03137329 on ClinicalTrials.gov