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ObesityNCT03137329

Surgical vs. Lifestyle in Obese Older Adults

A study testing Exercise program, Nutrition and WLS in people with Obesity, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 55 to 75 years
Conditions the study is for
Obesity
What is being tested?
Exercise program, Nutrition and WLS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
1 Jul 2016to 28 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: 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.
Read the 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
Being tested
Exercise program, Nutrition, WLS
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise programBehavioural

    Physical therapy for aerobic and resistance training exercises

  • NutritionDietary supplement

    Nutrition supplementation via HMR for lifestyle arm only

  • WLSProcedure or surgery

    Weight loss surgery as planned

Study groups in NCT03137329
Study groupRoleWhat they receive
Weight Loss Surgery (WLS) ArmOtherSubjects 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.
Receives: Behavioral: Exercise program; Procedure: WLS
Lifestyle ArmOtherSubjects 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.
Receives: Behavioral: Exercise program; Dietary Supplement: Nutrition

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.[

    Measured: Years 1 and 2

Secondary outcomes (12)

  1. Change in anthropometric measurements-body weight

    Changes in: body weight

    Measured: Years 1 and 2

  2. Change in anthropometric measurements-waist circumference

    Changes in: waist circumference

    Measured: Years 1 and 2

  3. Change in body composition

    Change in: fat mass, lean body mass of the whole body

    Measured: Years 1 and 2

  4. 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)

    Measured: Years 1 and 2

  5. Change in blood pressure

    Change in: blood pressure

    Measured: Years 1 and 2

  6. Change in biochemical assessments-hbA1C

    Change in: hemoglobin A1c,

    Measured: Years 1 and 2

  7. Change in biochemical assessments-insulin and glucose

    Change in: insulin and fasting glucose (insulin resistance)

    Measured: Years 1 and 2

  8. Change in biochemical assessments-bone and muscle metabolism

    Change in: biomarkers related to bone and muscle metabolism including vitamin D and bone alkaline phosphatase

    Measured: Years 1 and 2

  9. 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

    Measured: Years 1 and 2

  10. Change in pain

    Change in: pain score using the Brief Pain Inventory

    Measured: Years 1 and 2

  11. Change in disability

    Change in: difficulty performing ADLs and IADLs

    Measured: Years 1 and 2

  12. Change in medical history, medications and healthcare utilization from adverse events

    all visits, hospitalizations, and emergency room visits including any study related visits.

    Measured: Years 1 and 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2017
  2. Study start1 Jul 2016
  3. Primary completion28 Jun 2019
  4. Study completion28 Jun 2019

Why it stopped: Did not meet enrollment requirements with limited funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03137329
Sponsor's protocol ID
2016P000188
Status last verified
Jul 2019
First submitted
27 Mar 2017
Last updated
23 Jul 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise program, Nutrition and WLS in people with Obesity, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Did not meet enrollment requirements with limited funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Physical Function (time frame: Years 1 and 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03137329.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.

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