Status:
COMPLETED
Incorporating Nutrition, Vests, Education, and Strength Training in Bone Health (INVEST in Bone Health)
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Weight Loss
Bone Health
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief Summary
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 sub...
Detailed Description
The study team proposes that a 12 month trial in 150 older (60-85 years) adults with obesity (Body mass index or BMI=30-40 kg/m2 OR 27.0-\<30 kg/m² and one obesity-related risk factor) randomized to o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04076618
Start Date
August 12 2020
End Date
April 1 2024
Last Update
February 6 2025
Active Locations (1)
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1
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157