Incorporating Nutrition, Vests, Education, and Strength Training in Bone Health (INVEST in Bone Health)

Completed · Not applicable

Conditions studied: Weight Loss, Bone Health

In brief

The main goal of the proposed study is to compare the effects of weight loss (WL) alone with WL plus weighted vest use or WL plus resistance exercise training (RT) on indicators of bone health and subsequent fracture risk.

Key facts

Study ID: NCT04076618
Run by: Wake Forest University Health Sciences
People needed: 150
Starts: 2020-08-12
Expected to finish: 2024-04-01
Last updated by the study team: 2025-02-06

Who can join

Age: 60 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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)

Where it is running

Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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