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

Weight Loss Clinical Trial

— INVEST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04076618
• Other study ID #: IRB00058279
• Status: Completed
• Phase: N/A
• Start date: August 12, 2020
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 subsequent fracture risk.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Health
• Weight Loss

Intervention

Device:
• Vest
Weighted Vest worn > or = 8 hours per day

Behavioral:
• Resistance Exercise Training
Structured exercise training 3 days a week
• weight loss program
a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)

Locations

Country	Name	City	State
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mid-thigh muscle density measured in Hounsfield units (HU)	measurement taken during computed tomography (CT) scan	12 months from baseline
Other	Mid- thigh intermuscular fat cross sectional area (CSA) (cm2)	measurement taken during computed tomography (CT) scan	12 months from baseline
Other	Cortical thickness (mm)	measurement taken during computed tomography (CT) scan	12 months from baseline
Other	Finite element (FE) modeling of bone strength measured in Kilonewton (kN)	measurement taken during computed tomography (CT) scan	12 months from baseline
Other	Mid-thigh muscle CSA (cm2)	measurement taken during computed tomography (CT) scan	12 months from baseline
Other	L3 muscle density measured in HU	measurement taken during computed tomography (CT) scan	12 months from baseline
Other	L3 intermuscular fat CSA (cm2)	measurement taken during computed tomography (CT) scan	12 months from baseline
Other	L3 muscle CSA (cm2)	measurement taken during computed tomography (CT) scan	12 months from baseline
Other	Concentration of Procollagen 1 Intact N-Terminal Propeptide (P1NP) (ug/L)	Biomarkers of bone turnover measured via blood specimen	12 months from baseline
Other	Concentration of C-terminal telopeptide (CTX) (pg/mL)	Biomarkers of bone turnover measured via blood specimen	12 months from baseline
Other	D3-Creatine derived muscle mass measured in kg	measurement taken via urine sample	12 months from baseline
Other	Gait speed	measured in m/s during the 400 meter walk test	12 months from baseline
Other	expanded Short Physical Performance Battery (eSPPB)	The SPPB is a measure of balance, walking speed, and ability to stand from a chair. It provides a global measure of overall physical function and is a good predictor of future disability, institutionalization, and mortality in older persons. The SPPB score is calculated by assigning each of the test measures (balance, walking speed, and chair stands) a score from 0 (unable to do) to 4 (best) and then adding these scores together for a total score ranging from 0 to 12. An SPPB score less than 10 identifies persons at higher risk for mobility disability.	12 months from baseline
Other	Timed-Up-and-Go (TUG)	measured in seconds to assess physical performance; measures the time the participant takes to stand up from a standard chair, walk 3 meters, turn, walk back to the chair, and sit down again.	12 months from baseline
Other	Stair climbing time	measured in seconds using the participant's fastest time achieved to climb a 12 step staircase in two trials.	12 months from baseline
Other	Lower extremity muscle strength	measured using an isokinetic dynamometer with the participant sitting and the hips and knee flexed at 90°. Participants will be asked to extend the knee and push as hard as possible against the resistance pad. Strength is expressed as peak torque (Nm)	12 months from baseline
Other	Grip strength	measured twice in each hand to the nearest two kg using an isometric Jamar Hydraulic Hand Dynamometer with the mean value from the stronger hand used	12 months from baseline
Other	Cognitive Assessment	measured using the Montreal Cognitive Assessment (MOCA) with scores ranging from 0-30, with a score of 26 and higher generally considered normal.	12 months from baseline
Other	Fatigability	measured using the Pittsburgh Fatigability scale, which is a 10-item questionnaire that assesses fatigability, or the rate at which a person experiences mental or physical fatigue in the context of a standardized task. The scale ranges from 0-5, where those who exhibit more fatigability, score of 5, are more likely to limit activities of daily living and to reduce exertion during physical activities.	12 months from baseline
Other	Pain and Fatigue	measured using The Patient-Reported Outcomes Measurement Information System (PROMIS) instrument is an 8-item short-form that assesses pain and fatigue over the past 7 days. The scale ranges from 1-5, with higher scores indicated the presence of pain and fatigue.	12 months from baseline
Other	Physical activity among older adults	The CHAMPS questionnaire is a 40-43-item tool that assesses weekly frequency and duration of a variety of lifestyle physical activities that are appropriate for older adults. The purpose of this questionnaire is to evaluate the effectiveness of interventions to increase lifestyle physical activity among older adults. Physical activities are given a METS score, ranging from 2.0-7.0, where activities with an activities of moderate intensity (METS) score of 3.0 or higher, are considered moderate intensity.	12 months from baseline
Other	Overall limb loading	measured in Newtons via force-sensing insoles to assess overall limb loading and to determine if participants receive enough loading to prevent bone loss from resistance training and weighted vest use when compared to weight loss alone.	6 months from baseline
Other	Overall satisfaction participating in the optional insole visits	overall satisfaction measured by a scale from 1-5 with a higher score indicating greater satisfaction	6 months from baseline
Primary	Change in total hip trabecular volumetric bone mineral density (vBMD)	measured in mg/cm3 during computed tomography (CT) scan	12 months from baseline
Secondary	Change in total hip trabecular volumetric bone mineral density (vBMD)	measured in mg/cm3 during computed tomography (CT) scan	6 months from baseline
Secondary	Change in femoral neck volumetric bone mineral density (vBMD)	measured in mg/cm3 during computed tomography (CT) scan	12 months from baseline
Secondary	Change in lumbar spine volumetric bone mineral density (vBMD)	measured in mg/cm3 during computed tomography (CT) scan	12 months from baseline
Secondary	Trabecular bone score (TBS)	measurement taken during dual energy x-ray absorptiometry (DXA) scan; Trabecular Bone Score is a measure of bone architecture that has been shown to be an independent risk factor for fracture. The measure is unitless, and ranges from 1.0-1.6, where an elevated TBS greater than or equal to 1.3 appears to represent strong, fracture-resistant bone architecture, while a low TBS less than or equal to 1.2 reflects weak, fracture-prone bone architecture.	12 months from baseline
Secondary	Change in total hip areal bone mineral density (aBMD)	measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan	12 months from baseline
Secondary	Change in femoral neck areal bone mineral density (aBMD)	measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan	12 months from baseline
Secondary	Change in distal radius areal bone mineral density (aBMD)	measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan	12 months from baseline
Secondary	Change in lumbar spine areal bone mineral density (aBMD)	measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan	12 months from baseline
Secondary	Change in total body fat mass (kg)	measurement taken during dual energy x-ray absorptiometry (DXA) scan	12 months from baseline
Secondary	Change in total body lean mass (kg)	measurement taken during dual energy x-ray absorptiometry (DXA)	12 months from baseline