Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Bone Health
  • Weight Loss
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Investigator, Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Between 60 years and 85 years
Gender
Both males and females

Description

The study team proposes that a 12 month trial in 192 older (60-85 years) adults with obesity (Body mass index or BMI=30-40 kg/m2) randomized to one of three interventions (n=64/group): WL alone (WL; caloric restriction targeting 10% WL); WL plus weighted vest use (WL+Vest); targeting ?8 hours/day, w...

The study team proposes that a 12 month trial in 192 older (60-85 years) adults with obesity (Body mass index or BMI=30-40 kg/m2) randomized to one of three interventions (n=64/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.

Tracking Information

NCT #
NCT04076618
Collaborators
Not Provided
Investigators
Principal Investigator: Kristen Beavers, MD Wake Forest University Health Sciences