Surgical vs. Lifestyle in Obese Older Adults

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03137329
• Other study ID #: 2016P000188
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: June 28, 2019

Study information

• Verified date: July 2019
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 28, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in anthropometric measurements-body weight	Changes in: body weight	Years 1 and 2
Secondary	Change in anthropometric measurements-waist circumference	Changes in: waist circumference	Years 1 and 2
Secondary	Change in body composition	Change in: fat mass, lean body mass of the whole body	Years 1 and 2
Secondary	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
Secondary	Change in blood pressure	Change in: blood pressure	Years 1 and 2
Secondary	Change in biochemical assessments-hbA1C	Change in: hemoglobin A1c,	Years 1 and 2
Secondary	Change in biochemical assessments-insulin and glucose	Change in: insulin and fasting glucose (insulin resistance)	Years 1 and 2
Secondary	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
Secondary	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
Secondary	Change in pain	Change in: pain score using the Brief Pain Inventory	Years 1 and 2
Secondary	Change in disability	Change in: difficulty performing ADLs and IADLs	Years 1 and 2
Secondary	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