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

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 one of three interventions (n=50/group): WL alone (WL; caloric restriction targeting 10% WL); WL plus weighted vest use (WL+Vest); targeting ≥8 hours/day, weight replacement titrated up to 10% WL); or, WL plus structured RT (WL+RT; 3 days/week). Total hip trabecular volumetric bone mineral density (vBMD) is the primary outcome. This outcome will be complemented by exploratory assessment of several fracture-related risk factors, including: (1) femoral neck and lumbar spine vBMD, cortical thickness, finite element modeling of bone strength, and regional fat and muscle volumes, measured by CT; (2) areal bone mineral density (aBMD) at the total hip, femoral neck, lumbar spine, and distal radius; trabecular bone score; and total body fat/lean masses, measured by dual energy x-ray absorptiometry (DXA); (3) muscle function and strength; (4) biomarkers of bone turnover; and (5) bone-regulating hormones/cytokines known to influence bone metabolism during WL. Therefore, the investigators Specific Aims are to:

Aim 1: Determine the effects of WL+Vest compared to WL and WL+RT on 12 month change in total hip trabecular vBMD. Despite similar reductions in total body weight, Hypothesis 1: Participants in the WL+Vest group will show attenuated losses of total hip trabecular vBMD versus WL; and Hypothesis 2: Loss in total hip trabecular vBMD will be no greater in WL+Vest compared to WL+RT.

Aim 2: Explore the effects of WL+Vest compared to WL and WL+RT on the 12 month change in fracture-related risk factors. Despite similar reductions in total body weight, we hypothesize that WL+Vest and WL+RT will demonstrate improvements in fracture-related risk factors compared to WL.

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