Surgical vs. Lifestyle in Obese Older Adults

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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Exercise program; Procedure: WLS; Dietary supplement: Nutrition

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Behavioral: Exercise program; Physical therapy for aerobic and resistance training exercises; Procedure: WLS; Weight loss surgery as planned
Other: 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.	Behavioral: Exercise program; Physical therapy for aerobic and resistance training exercises; Dietary supplement: Nutrition; Nutrition supplementation via HMR for lifestyle arm only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Function	The primary outcome will be change in physical function as measured change in score on the Short Physical Performance Battery (SPPB) between the two groups at 6 months and 12 months. Secondary physical function outcomes includes change in performance on the Timed 400m walk and the sum of the one-repetition maximal weight subjects are able to lift in the biceps curl, bench press, seated row, knee extension and flexion, and leg press.[	Years 1 and 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anthropometric measurements-body weight	Changes in: body weight	Years 1 and 2
Change in anthropometric measurements-waist circumference	Changes in: waist circumference	Years 1 and 2
Change in body composition	Change in: fat mass, lean body mass of the whole body	Years 1 and 2
Change in bone mineral density	Change in: bone density at the total hip and radius as measured by dual energy x-ray absorptiometry (DEXA) among subjects who weigh up to 450 lbs (equipment weight limit)	Years 1 and 2
Change in blood pressure	Change in: blood pressure	Years 1 and 2
Change in biochemical assessments-hbA1C	Change in: hemoglobin A1c,	Years 1 and 2
Change in biochemical assessments-insulin and glucose	Change in: insulin and fasting glucose (insulin resistance)	Years 1 and 2
Change in biochemical assessments-bone and muscle metabolism	Change in: biomarkers related to bone and muscle metabolism including vitamin D and bone alkaline phosphatase	Years 1 and 2
Change in quality of life	Change in: Quality of life scores as measured by the Impact of Weight on Quality of Life and the Short Form-36	Years 1 and 2
Change in pain	Change in: pain score using the Brief Pain Inventory	Years 1 and 2
Change in disability	Change in: difficulty performing ADLs and IADLs	Years 1 and 2
Change in medical history, medications and healthcare utilization from adverse events	all visits, hospitalizations, and emergency room visits including any study related visits.	Years 1 and 2

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Christina C Wee, MD, MPH, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): June 28, 2019
• Study Completion (Actual): June 28, 2019

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: May 1, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 19, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2016P000188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No