Surgical vs. Lifestyle in Obese Older Adults

NCT03137329 | Terminated

• 1 other identifier: 2016P000188
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims are

1. 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. 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

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in anthropometric measurements-body weight

  Years 1 and 2

• Change in anthropometric measurements-waist circumference

  Years 1 and 2

• Change in body composition

  Years 1 and 2

• Change in bone mineral density

  Years 1 and 2

• Change in blood pressure

  Years 1 and 2

Study Arms (2)

Weight Loss Surgery (WLS) Arm

OTHER

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; Procedure: WLS

Lifestyle Arm

OTHER

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; Dietary Supplement: Nutrition

Interventions

Exercise program BEHAVIORAL

Physical therapy for aerobic and resistance training exercises

Lifestyle Arm; Weight Loss Surgery (WLS) Arm

Nutrition DIETARY_SUPPLEMENT

Nutrition supplementation via HMR for lifestyle arm only

Lifestyle Arm

WLS PROCEDURE

Weight loss surgery as planned

Weight Loss Surgery (WLS) Arm

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Resistance Training; Nutritional Status

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Christina C Wee, MD, MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: May 2, 2017
• Study Start: July 1, 2016
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)