Surgical vs. Lifestyle in Obese Older Adults

NCT ID: NCT03137329

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2019-06-28

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Weight Loss Surgery (WLS) Arm

Subjects enrolled in the WLS arm will undergo WLS as part of the routine care provided by the respective WLS centers. During routine care patients typically meet with their dietician at least twice prior to WLS and are placed on a higher protein meal replacement supplement and calorie controlled diet. For weeks 1-52, the investigators will ensure that patients are receiving 1500mg of elemental calcium and 3000 IU of vitamin D based on recent best practice guidelines. In addition, participants will complete an individualized pragmatic exercise program for the first 52 weeks after surgery. Patients will begin the program after receiving clearance from their surgeon. Patients will meet with a physical therapist at BIDMC for individual sessions.

Group Type: OTHER

Exercise program

Intervention Type: BEHAVIORAL

Physical therapy for aerobic and resistance training exercises

WLS

Intervention Type: PROCEDURE

Weight loss surgery as planned

Lifestyle Arm

Subjects enrolled in the lifestyle group will be prescribed a balanced high protein diet (1g high quality protein/kg body weight/day) that provides an energy deficit of 500 to 750 kcal /day from their daily energy requirements\[58\] and prescribed a weight loss goal of 10% over the course of 6 months. Participants will meet with a trained dietician/nutritionist at the BIDMC General Clinical Research Unit. The investigators will incorporate the HMR (Health Management Resources) high protein meal replacement supplements into participants' diet regimen for the first 24 weeks. In addition, participants will complete a comparable 52-week exercise program consisting of an individualized pragmatic exercise program.

Group Type: OTHER

Exercise program

Intervention Type: BEHAVIORAL

Physical therapy for aerobic and resistance training exercises

Nutrition

Intervention Type: DIETARY_SUPPLEMENT

Nutrition supplementation via HMR for lifestyle arm only

Interventions

Exercise program

Physical therapy for aerobic and resistance training exercises

Intervention Type: BEHAVIORAL

Nutrition

Nutrition supplementation via HMR for lifestyle arm only

Intervention Type: DIETARY_SUPPLEMENT

WLS

Weight loss surgery as planned

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Christina Wee

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christina C Wee, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2016P000188

Identifier Type: -

Identifier Source: org_study_id