Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT04076618
Eligibility Criteria:
Inclusion Criteria:
* Age 60-85 years
* BMI=30-40 kg/m\^2 or BMI 27.0-\<30.0 kg/m\^2 plus one risk factor
* Weight stability - no weight loss \> 5% in past 6 months
* No contraindications for safe and optimal participation in exercise training/vest use.
* Approved for participation by Study Coordinator
* Willing to provide informed consent; agree to all study procedures and assessments; Able to provide own transit to assessment/intervention visits
* Willing to complete online/electronic study forms and participate in virtual group sessions, as needed.
Exclusion Criteria:
* Weight greater than 450 lbs
* Dependent on cane or walker: \>2 falls (injurious on non-injurious) in past year
* Any contraindications for participation in voluntary weight loss
* Smoker (\>1 cigarette/d or 4/wk within yr); Excessive alcohol use (\>14 drinks/wk)
* Participation in regular resistance training and/or high intensity/high impact aerobic exercise for \>60 mins per day on \> 5 days/week for the past 6 months
* Evidence of cognitive impairment (MoCA\<20)
* Osteoporosis (self-report and on prescription medication, T-score \< or = -2.5 on total hip, femoral neck, lumbar spine or distal radius scan at screening visit, or fracture risk assessment tool (FRAX) 10-year risk scores \>3% for hip fracture or \>20% for major osteoporotic fracture (TBS adjusted FRAX is preferable if available)
* Self-reported prior spine, hip, wrist, or shoulder fracture after age 40 (except when caused by trauma or fall from height)
* Chronic back/shoulder/knee pain with current or past (within 1 year) prescription medication use for at least 3 months
* Severe, diagnosed arthritis (osteoarthritis, rheumatoid arthritis, or gout) with current or past (within 1 year) prescription medication use for at least 3 months
* Past (ever) or planned (next 12 months) back surgery
* Past (6 months prior) or planned (next 12 months) joint replacement surgery; or past (ever) unilateral or bilateral hip replacement surgery
* Past (ever) metal device or fixation in the hip, pelvis, or femur
* Uncontrolled hypertension (BP \> 160/90 mmHg)
* Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease requiring oxygen, neurological or hematological disease requiring treatment for at least 3 months in past year
* Cancer requiring treatment in past year, except non-melanoma skin cancer
* Low Vitamin D (\<20 ng/mL)
* Abnormal kidney or liver function (2x upper limits of normal)
* estimated glomerular filtration rate (eGFR)\<45 mL/min/1.73m2,
* Anemia (Hb \<13 g/dL in men/\<12 g/dL in women)
* Uncontrolled diabetes (fasting glucose \> 140 mg/dL)
* Regular use of: growth hormones, weight loss medications, oral steroids, insulin, or prescription osteoporosis medications in the past year
* No home computer, laptop or tablet with reliable home internet OR no smartphone (touch-screen enabled phone) with reliable unlimited mobile internet
* Involved in another behavioral/interventional research study, weight loss program, or undergoing physical therapy.
* Unable to tolerate diet, vest, or CT scan (claustrophobia)
* Judged unsuitable for the trial for any reason by clinic staff
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT04076618
Study Brief:
Protocol Section:
NCT04076618