Clinical trial NCT03137329: Surgical vs. Lifestyle in Obese Older Adults
Official title: Comparison of Surgical vs. Lifestyle Weight Treatment in Obese Older Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 2
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Physical Function
timeFrame: Years 1 and 2
Secondary outcomes:
measure: Change in anthropometric measurements-body weight
timeFrame: Years 1 and 2
measure: Change in anthropometric measurements-waist circumference
timeFrame: Years 1 and 2
measure: Change in body composition
timeFrame: Years 1 and 2
measure: Change in bone mineral density
timeFrame: Years 1 and 2
measure: Change in blood pressure
timeFrame: Years 1 and 2
measure: Change in biochemical assessments-hbA1C
timeFrame: Years 1 and 2
measure: Change in biochemical assessments-insulin and glucose
timeFrame: Years 1 and 2
measure: Change in biochemical assessments-bone and muscle metabolism
timeFrame: Years 1 and 2
measure: Change in quality of life
timeFrame: Years 1 and 2
measure: Change in pain
timeFrame: Years 1 and 2
measure: Change in disability
timeFrame: Years 1 and 2
measure: Change in medical history, medications and healthcare utilization from adverse events
timeFrame: Years 1 and 2
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Christina C Wee, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: