Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT04076618
Status:
COMPLETED
Last Update Posted:
2025-02-06
First Post:
2019-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Incorporating Nutrition, Vests, Education, and Strength Training in Bone Health (INVEST in Bone Health)
Sponsor:
Organization:
Raw JSON
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'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D006293', 'term': 'Health Promotion'}, {'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kbeavers@wakehealth.edu', 'phone': '336-758-5855', 'title': 'Kristen Beavers, PhD, MPH, RD', 'organization': 'Wake Forest University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline through Month 12', 'eventGroups': [{'id': 'EG000', 'title': 'Weight Loss Plus Vest', 'description': 'Vest: Weighted Vest worn \\> or = 8 hours per day\n\nweight loss program: a 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss Plus Vest', 'description': 'Vest: Weighted Vest worn \\> or = 8 hours per day\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary 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'45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss Plus Vest', 'description': 'Vest: Weighted Vest worn \\> or = 8 hours per day\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG001', 'title': 'Weight Loss Plus Resistance Exercise Training', 'description': 'Resistance Exercise Training: Structured exercise training 3 days a week\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG002', 'title': 'Weight Loss', 'description': 'weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.000', 'groupId': 'OG000', 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Loss Plus Vest', 'description': 'Vest: Weighted Vest worn \\> or = 8 hours per day\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG001', 'title': 'Weight Loss Plus Resistance Exercise Training', 'description': 'Resistance Exercise Training: Structured exercise training 3 days a week\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG002', 'title': 'Weight Loss', 'description': 'weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.020', 'groupId': 'OG000', 'lowerLimit': '0.002', 'upperLimit': '0.039'}, {'value': '0.037', 'groupId': 'OG001', 'lowerLimit': '0.018', 'upperLimit': '0.056'}, {'value': '0.017', 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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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '5 participants in Weight Loss Plus Vest arm did not complete DXA scan. 5 participants in Weight Loss Plus Resistance Exercise Training Arm did not complete DXA scan. 7 participants in Weight Loss arm did not complete DXA scan.'}, {'type': 'SECONDARY', 'title': 'Change in Total Hip Areal Bone Mineral Density (aBMD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss Plus Vest', 'description': 'Vest: Weighted Vest worn \\> or = 8 hours per 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'description': 'Resistance Exercise Training: Structured exercise training 3 days a week\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG002', 'title': 'Weight Loss', 'description': 'weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.000', 'groupId': 'OG000', 'lowerLimit': '-0.011', 'upperLimit': '0.010'}, {'value': '0.004', 'groupId': 'OG001', 'lowerLimit': '-0.007', 'upperLimit': '0.014'}, {'value': '0.004', 'groupId': 'OG002', 'lowerLimit': '-0.007', 'upperLimit': '0.015'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months from baseline', 'description': 'measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan', 'unitOfMeasure': 'g/cm2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants in Weight Loss Plus Vest arm did not complete DXA scan. 3 participants in Weight Loss Plus Resistance Exercise Training arm did not complete DXA scan. 5 participants in Weight Loss arm did not complete DXA scan.'}, {'type': 'SECONDARY', 'title': 'Change in Femoral Neck Areal Bone Mineral Density (aBMD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss Plus Vest', 'description': 'Vest: Weighted Vest worn \\> or = 8 hours per day\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG001', 'title': 'Weight Loss Plus Resistance Exercise Training', 'description': 'Resistance Exercise Training: Structured exercise training 3 days a week\n\nweight loss program: a 24-week 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participants in Weight Loss Plus Resistance Exercise Training arm did not complete DXA scan. 7 participants in Weight Loss arm did not complete DXA scan.'}, {'type': 'SECONDARY', 'title': 'Change in Distal Radius Areal Bone Mineral Density (aBMD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss Plus Vest', 'description': 'Vest: Weighted Vest worn \\> or = 8 hours per day\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG001', 'title': 'Weight Loss Plus Resistance Exercise Training', 'description': 'Resistance Exercise Training: Structured exercise training 3 days a week\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary 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Areal Bone Mineral Density (aBMD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss Plus Vest', 'description': 'Vest: Weighted Vest worn \\> or = 8 hours per day\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG001', 'title': 'Weight Loss Plus Resistance Exercise Training', 'description': 'Resistance Exercise Training: Structured exercise training 3 days a week\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG002', 'title': 'Weight Loss', 'description': 'weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary 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'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss Plus Vest', 'description': 'Vest: Weighted Vest worn \\> or = 8 hours per day\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG001', 'title': 'Weight Loss Plus Resistance Exercise Training', 'description': 'Resistance Exercise Training: Structured exercise training 3 days a week\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG002', 'title': 'Weight Loss', 'description': 'weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.006', 'groupId': 'OG000', 'lowerLimit': 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Plus Vest', 'description': 'Vest: Weighted Vest worn \\> or = 8 hours per day\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG001', 'title': 'Weight Loss Plus Resistance Exercise Training', 'description': 'Resistance Exercise Training: Structured exercise training 3 days a week\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG002', 'title': 'Weight Loss', 'description': 'weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.8', 'groupId': 'OG000', 'lowerLimit': '-9.1', 'upperLimit': '-6.5'}, {'value': '-8.8', 'groupId': 'OG001', 'lowerLimit': '-10.2', 'upperLimit': '-7.5'}, {'value': '-7.8', 'groupId': 'OG002', 'lowerLimit': '-9.2', 'upperLimit': '-6.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months from baseline', 'description': 'measurement taken during dual energy x-ray absorptiometry (DXA) scan', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants in Weight Loss Plus Vest arm did not complete DXA scan. 3 participants in Weight Loss Plus Resistance Exercise Training arm did not complete DXA scan. 5 participants in Weight Loss arm did not complete DXA scan.'}, {'type': 'SECONDARY', 'title': 'Change in Total Body Fat Mass (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss Plus Vest', 'description': 'Vest: Weighted Vest worn \\> or = 8 hours per day\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG001', 'title': 'Weight Loss Plus Resistance Exercise Training', 'description': 'Resistance Exercise Training: Structured exercise training 3 days a week\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG002', 'title': 'Weight Loss', 'description': 'weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.3', 'groupId': 'OG000', 'lowerLimit': '-8.9', 'upperLimit': '-5.7'}, {'value': '-10.0', 'groupId': 'OG001', 'lowerLimit': '-11.6', 'upperLimit': '-8.3'}, {'value': '-7.7', 'groupId': 'OG002', 'lowerLimit': '-9.4', 'upperLimit': '-6.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during dual energy x-ray absorptiometry (DXA) scan', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '5 participants in Weight Loss Plus Vest arm did not complete DXA scan. 5 participants in Weight Loss Plus Resistance Exercise Training arm did not complete DXA scan. 7 participants in Weight Loss arm did not complete DXA scan.'}, {'type': 'SECONDARY', 'title': 'Change in Total Body Lean Mass (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss Plus Vest', 'description': 'Vest: Weighted Vest worn \\> or = 8 hours per day\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG001', 'title': 'Weight Loss Plus Resistance Exercise Training', 'description': 'Resistance Exercise Training: Structured exercise training 3 days a week\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG002', 'title': 'Weight Loss', 'description': 'weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '0.0'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '-0.2'}, {'value': '-0.7', 'groupId': 'OG002', 'lowerLimit': '-1.2', 'upperLimit': '-0.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months from baseline', 'description': 'measurement taken during dual energy x-ray absorptiometry (DXA)', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants in Weight Loss Plus Vest arm did not complete DXA scan. 3 participants in Weight Loss Plus Resistance Exercise Training arm did not complete DXA scan. 5 participants in Weight Loss arm did not complete DXA scan.'}, {'type': 'SECONDARY', 'title': 'Change in Total Body Lean Mass (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Loss Plus Vest', 'description': 'Vest: Weighted Vest worn \\> or = 8 hours per day\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG001', 'title': 'Weight Loss Plus Resistance Exercise Training', 'description': 'Resistance Exercise Training: Structured exercise training 3 days a week\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'OG002', 'title': 'Weight Loss', 'description': 'weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '-0.2'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '-0.3'}, {'value': '-0.9', 'groupId': 'OG002', 'lowerLimit': '-1.5', 'upperLimit': '-0.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during dual energy x-ray absorptiometry (DXA)', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '5 participants in Weight Loss Plus Vest arm did not complete DXA scan. 5 participants in Weight Loss Plus Resistance Exercise Training arm did not complete DXA scan. 7 participants in Weight Loss arm did not complete DXA scan.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mid-thigh Muscle Density Measured in Hounsfield Units (HU)', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during computed tomography (CT) scan', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mid- Thigh Intermuscular Fat Cross Sectional Area (CSA) (cm2)', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during computed tomography (CT) scan', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cortical Thickness (mm)', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during computed tomography (CT) scan', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Finite Element (FE) Modeling of Bone Strength Measured in Kilonewton (kN)', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during computed tomography (CT) scan', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mid-thigh Muscle CSA (cm2)', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during computed tomography (CT) scan', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'L3 Muscle Density Measured in HU', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during computed tomography (CT) scan', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'L3 Intermuscular Fat CSA (cm2)', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during computed tomography (CT) scan', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'L3 Muscle CSA (cm2)', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during computed tomography (CT) scan', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Concentration of Procollagen 1 Intact N-Terminal Propeptide (P1NP) (ug/L)', 'timeFrame': '12 months from baseline', 'description': 'Biomarkers of bone turnover measured via blood specimen', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Concentration of C-terminal Telopeptide (CTX) (pg/mL)', 'timeFrame': '12 months from baseline', 'description': 'Biomarkers of bone turnover measured via blood specimen', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'D3-Creatine Derived Muscle Mass Measured in kg', 'timeFrame': '12 months from baseline', 'description': 'measurement taken via urine sample', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Gait Speed', 'timeFrame': '12 months from baseline', 'description': 'measured in m/s during the 400 meter walk test', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Expanded Short Physical Performance Battery (eSPPB)', 'timeFrame': '12 months from baseline', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Timed-Up-and-Go (TUG)', 'timeFrame': '12 months from baseline', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Stair Climbing Time', 'timeFrame': '12 months from baseline', 'description': "measured in seconds using the participant's fastest time achieved to climb a 12 step staircase in two trials.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Lower Extremity Muscle Strength', 'timeFrame': '12 months from baseline', 'description': '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)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Grip Strength', 'timeFrame': '12 months from baseline', 'description': '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', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cognitive Assessment', 'timeFrame': '12 months from baseline', 'description': 'measured using the Montreal Cognitive Assessment (MOCA) with scores ranging from 0-30, with a score of 26 and higher generally considered normal.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Fatigability', 'timeFrame': '12 months from baseline', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pain and Fatigue', 'timeFrame': '12 months from baseline', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Physical Activity Among Older Adults', 'timeFrame': '12 months from baseline', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Limb Loading', 'timeFrame': '6 months from baseline', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Satisfaction Participating in the Optional Insole Visits', 'timeFrame': '6 months from baseline', 'description': 'overall satisfaction measured by a scale from 1-5 with a higher score indicating greater satisfaction', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Weight Loss Plus Vest', 'description': 'Vest: Weighted Vest worn \\> or = 8 hours per day\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'FG001', 'title': 'Weight Loss Plus Resistance Exercise Training', 'description': 'Resistance Exercise Training: Structured exercise training 3 days a week\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'FG002', 'title': 'Weight Loss', 'description': 'weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Relocated out of state', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COVID concerns', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Weight Loss Plus Vest', 'description': 'Vest: Weighted Vest worn \\> or = 8 hours per day\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'BG001', 'title': 'Weight Loss Plus Resistance Exercise Training', 'description': 'Resistance Exercise Training: Structured exercise training 3 days a week\n\nweight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'BG002', 'title': 'Weight Loss', 'description': 'weight loss program: a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '66.9', 'spread': '4.5', 'groupId': 'BG000'}, {'value': '66.4', 'spread': '5.1', 'groupId': 'BG001'}, {'value': '65.9', 'spread': '4.2', 'groupId': 'BG002'}, {'value': '66.4', 'spread': '4.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '147', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (kg/m2)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '93.6', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '92.7', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '92.3', 'spread': '14.3', 'groupId': 'BG002'}, {'value': '92.9', 'spread': '12.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '166.5', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '166.0', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '166.0', 'spread': '8.8', 'groupId': 'BG002'}, {'value': '166.2', 'spread': '8.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '33.8', 'spread': '3.7', 'groupId': 'BG000'}, {'value': '33.6', 'spread': '3.0', 'groupId': 'BG001'}, {'value': '33.4', 'spread': '3.3', 'groupId': 'BG002'}, {'value': '33.6', 'spread': '3.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Education', 'classes': [{'title': 'High School Equivalent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}, {'title': 'College', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}]}, {'title': 'Post Graduate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbidities', 'classes': [{'title': 'Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Cardiovascular Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'Arthritis/Joint Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Low Bone Mass', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total Physical Activity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1941', 'groupId': 'BG000', 'lowerLimit': '1272', 'upperLimit': '2886'}, {'value': '2144', 'groupId': 'BG001', 'lowerLimit': '1147', 'upperLimit': '3514'}, {'value': '2042', 'groupId': 'BG002', 'lowerLimit': '1179', 'upperLimit': '3345'}, {'value': '2029', 'groupId': 'BG003', 'lowerLimit': '1179', 'upperLimit': '3263'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Kilocalories Per Week', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Fast Gait Speed', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '145', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '1.3', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '1.3', 'spread': '0.1', 'groupId': 'BG002'}, {'value': '1.3', 'spread': '0.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Meters Per Second', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '3 participants in the Weight Loss Plus Vest arm did not complete this task at baseline. 2 participants in the Resistance Exercise Training arm did not complete this task at baseline.'}, {'title': 'Moderate Intensity Physical Activity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '165'}, {'value': '45', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '135'}, {'value': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '105'}, {'value': '30', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '135'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Minutes Per Week', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-04', 'size': 471094, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-13T10:35', 'hasProtocol': True}, {'date': '2024-03-05', 'size': 197956, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-29T10:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2019-08-29', 'resultsFirstSubmitDate': '2025-01-15', 'studyFirstSubmitQcDate': '2019-08-30', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-15', 'studyFirstPostDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mid-thigh Muscle Density Measured in Hounsfield Units (HU)', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during computed tomography (CT) scan'}, {'measure': 'Mid- Thigh Intermuscular Fat Cross Sectional Area (CSA) (cm2)', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during computed tomography (CT) scan'}, {'measure': 'Cortical Thickness (mm)', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during computed tomography (CT) scan'}, {'measure': 'Finite Element (FE) Modeling of Bone Strength Measured in Kilonewton (kN)', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during computed tomography (CT) scan'}, {'measure': 'Mid-thigh Muscle CSA (cm2)', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during computed tomography (CT) scan'}, {'measure': 'L3 Muscle Density Measured in HU', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during computed tomography (CT) scan'}, {'measure': 'L3 Intermuscular Fat CSA (cm2)', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during computed tomography (CT) scan'}, {'measure': 'L3 Muscle CSA (cm2)', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during computed tomography (CT) scan'}, {'measure': 'Concentration of Procollagen 1 Intact N-Terminal Propeptide (P1NP) (ug/L)', 'timeFrame': '12 months from baseline', 'description': 'Biomarkers of bone turnover measured via blood specimen'}, {'measure': 'Concentration of C-terminal Telopeptide (CTX) (pg/mL)', 'timeFrame': '12 months from baseline', 'description': 'Biomarkers of bone turnover measured via blood specimen'}, {'measure': 'D3-Creatine Derived Muscle Mass Measured in kg', 'timeFrame': '12 months from baseline', 'description': 'measurement taken via urine sample'}, {'measure': 'Gait Speed', 'timeFrame': '12 months from baseline', 'description': 'measured in m/s during the 400 meter walk test'}, {'measure': 'Expanded Short Physical Performance Battery (eSPPB)', 'timeFrame': '12 months from baseline', 'description': '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.'}, {'measure': 'Timed-Up-and-Go (TUG)', 'timeFrame': '12 months from baseline', 'description': '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.'}, {'measure': 'Stair Climbing Time', 'timeFrame': '12 months from baseline', 'description': "measured in seconds using the participant's fastest time achieved to climb a 12 step staircase in two trials."}, {'measure': 'Lower Extremity Muscle Strength', 'timeFrame': '12 months from baseline', 'description': '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)'}, {'measure': 'Grip Strength', 'timeFrame': '12 months from baseline', 'description': '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'}, {'measure': 'Cognitive Assessment', 'timeFrame': '12 months from baseline', 'description': 'measured using the Montreal Cognitive Assessment (MOCA) with scores ranging from 0-30, with a score of 26 and higher generally considered normal.'}, {'measure': 'Fatigability', 'timeFrame': '12 months from baseline', 'description': '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.'}, {'measure': 'Pain and Fatigue', 'timeFrame': '12 months from baseline', 'description': '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.'}, {'measure': 'Physical Activity Among Older Adults', 'timeFrame': '12 months from baseline', 'description': '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.'}, {'measure': 'Overall Limb Loading', 'timeFrame': '6 months from baseline', 'description': '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.'}, {'measure': 'Overall Satisfaction Participating in the Optional Insole Visits', 'timeFrame': '6 months from baseline', 'description': 'overall satisfaction measured by a scale from 1-5 with a higher score indicating greater satisfaction'}], 'primaryOutcomes': [{'measure': 'Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD)', 'timeFrame': '12 months from baseline', 'description': 'measured in mg/cm3 during computed tomography (CT) scan'}], 'secondaryOutcomes': [{'measure': 'Change in Total Hip Trabecular Volumetric Bone Mineral Density (vBMD)', 'timeFrame': '6 months from baseline', 'description': 'measured in mg/cm3 during computed tomography (CT) scan'}, {'measure': 'Change in Femoral Neck Volumetric Bone Mineral Density (vBMD)', 'timeFrame': '6 months from baseline', 'description': 'measured in mg/cm3 during computed tomography (CT) scan'}, {'measure': 'Change in Femoral Neck Volumetric Bone Mineral Density (vBMD)', 'timeFrame': '12 months from baseline', 'description': 'measured in mg/cm3 during computed tomography (CT) scan'}, {'measure': 'Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD)', 'timeFrame': '6 months from baseline', 'description': 'measured in mg/cm3 during computed tomography (CT) scan'}, {'measure': 'Change in Lumbar Spine Volumetric Bone Mineral Density (vBMD)', 'timeFrame': '12 months from baseline', 'description': 'measured in mg/cm3 during computed tomography (CT) scan'}, {'measure': 'Change in Trabecular Bone Score (TBS)', 'timeFrame': '6 months from baseline', 'description': '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.'}, {'measure': 'Change in Trabecular Bone Score (TBS)', 'timeFrame': '12 months from baseline', 'description': '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.'}, {'measure': 'Change in Total Hip Areal Bone Mineral Density (aBMD)', 'timeFrame': '6 months from baseline', 'description': 'measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan'}, {'measure': 'Change in Total Hip Areal Bone Mineral Density (aBMD)', 'timeFrame': '12 months from baseline', 'description': 'measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan'}, {'measure': 'Change in Femoral Neck Areal Bone Mineral Density (aBMD)', 'timeFrame': '6 months from baseline', 'description': 'measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan'}, {'measure': 'Change in Femoral Neck Areal Bone Mineral Density (aBMD)', 'timeFrame': '12 months from baseline', 'description': 'measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan'}, {'measure': 'Change in Distal Radius Areal Bone Mineral Density (aBMD)', 'timeFrame': '6 months from baseline', 'description': 'measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan'}, {'measure': 'Change in Distal Radius Areal Bone Mineral Density (aBMD)', 'timeFrame': '12 months from baseline', 'description': 'measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan'}, {'measure': 'Change in Lumbar Spine Areal Bone Mineral Density (aBMD)', 'timeFrame': '6 months from baseline', 'description': 'measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan'}, {'measure': 'Change in Lumbar Spine Areal Bone Mineral Density (aBMD)', 'timeFrame': '12 months from baseline', 'description': 'measured in g/cm2 during dual energy x-ray absorptiometry (DXA) scan'}, {'measure': 'Change in Total Body Fat Mass (kg)', 'timeFrame': '6 months from baseline', 'description': 'measurement taken during dual energy x-ray absorptiometry (DXA) scan'}, {'measure': 'Change in Total Body Fat Mass (kg)', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during dual energy x-ray absorptiometry (DXA) scan'}, {'measure': 'Change in Total Body Lean Mass (kg)', 'timeFrame': '6 months from baseline', 'description': 'measurement taken during dual energy x-ray absorptiometry (DXA)'}, {'measure': 'Change in Total Body Lean Mass (kg)', 'timeFrame': '12 months from baseline', 'description': 'measurement taken during dual energy x-ray absorptiometry (DXA)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['nutrition', 'vest'], 'conditions': ['Weight Loss', 'Bone Health']}, 'referencesModule': {'references': [{'pmid': '40540267', 'type': 'DERIVED', 'citation': 'Beavers KM, Lynch SD, Fanning J, Howard M, Lawrence E, Lenchik L, Shapses SA, Weaver AA, Wherry SJ, Zamora Z, Nicklas BJ, Beavers DP. Weighted Vest Use or Resistance Exercise to Offset Weight Loss-Associated Bone Loss in Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2516772. doi: 10.1001/jamanetworkopen.2025.16772.'}, {'pmid': '37668075', 'type': 'DERIVED', 'citation': 'Beavers KM, Avery AE, Shankaran M, Evans WJ, Lynch SD, Dwyer C, Howard M, Beavers DP, Weaver AA, Lenchik L, Cawthon PM. Application of the D3 -creatine muscle mass assessment tool to a geriatric weight loss trial: A pilot study. J Cachexia Sarcopenia Muscle. 2023 Oct;14(5):2350-2358. doi: 10.1002/jcsm.13322. Epub 2023 Sep 5.'}, {'pmid': '33631359', 'type': 'DERIVED', 'citation': 'Miller RM, Beavers DP, Cawthon PM, Crotts C, Fanning J, Gerosa J, Greene KA, Hsieh KL, Kiel J, Lawrence E, Lenchik L, Lynch SD, Nesbit BA, Nicklas BJ, Weaver AA, Beavers KM. Incorporating Nutrition, Vests, Education, and Strength Training (INVEST) in Bone Health: Trial Design and Methods. Contemp Clin Trials. 2021 May;104:106326. doi: 10.1016/j.cct.2021.106326. Epub 2021 Feb 22.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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:\n\nAim 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.\n\nAim 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 60-85 years\n* BMI=30-40 kg/m\\^2 or BMI 27.0-\\<30.0 kg/m\\^2 plus one risk factor\n* Weight stability - no weight loss \\> 5% in past 6 months\n* No contraindications for safe and optimal participation in exercise training/vest use.\n* Approved for participation by Study Coordinator\n* Willing to provide informed consent; agree to all study procedures and assessments; Able to provide own transit to assessment/intervention visits\n* Willing to complete online/electronic study forms and participate in virtual group sessions, as needed.\n\nExclusion Criteria:\n\n* Weight greater than 450 lbs\n* Dependent on cane or walker: \\>2 falls (injurious on non-injurious) in past year\n* Any contraindications for participation in voluntary weight loss\n* Smoker (\\>1 cigarette/d or 4/wk within yr); Excessive alcohol use (\\>14 drinks/wk)\n* 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\n* Evidence of cognitive impairment (MoCA\\<20)\n* 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)\n* Self-reported prior spine, hip, wrist, or shoulder fracture after age 40 (except when caused by trauma or fall from height)\n* Chronic back/shoulder/knee pain with current or past (within 1 year) prescription medication use for at least 3 months\n* Severe, diagnosed arthritis (osteoarthritis, rheumatoid arthritis, or gout) with current or past (within 1 year) prescription medication use for at least 3 months\n* Past (ever) or planned (next 12 months) back surgery\n* Past (6 months prior) or planned (next 12 months) joint replacement surgery; or past (ever) unilateral or bilateral hip replacement surgery\n* Past (ever) metal device or fixation in the hip, pelvis, or femur\n* Uncontrolled hypertension (BP \\> 160/90 mmHg)\n* 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\n* Cancer requiring treatment in past year, except non-melanoma skin cancer\n* Low Vitamin D (\\<20 ng/mL)\n* Abnormal kidney or liver function (2x upper limits of normal)\n* estimated glomerular filtration rate (eGFR)\\<45 mL/min/1.73m2,\n* Anemia (Hb \\<13 g/dL in men/\\<12 g/dL in women)\n* Uncontrolled diabetes (fasting glucose \\> 140 mg/dL)\n* Regular use of: growth hormones, weight loss medications, oral steroids, insulin, or prescription osteoporosis medications in the past year\n* No home computer, laptop or tablet with reliable home internet OR no smartphone (touch-screen enabled phone) with reliable unlimited mobile internet\n* Involved in another behavioral/interventional research study, weight loss program, or undergoing physical therapy.\n* Unable to tolerate diet, vest, or CT scan (claustrophobia)\n* Judged unsuitable for the trial for any reason by clinic staff'}, 'identificationModule': {'nctId': 'NCT04076618', 'acronym': 'INVEST', 'briefTitle': 'Incorporating Nutrition, Vests, Education, and Strength Training in Bone Health (INVEST in Bone Health)', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Incorporating Nutrition, Vests, Education, and Strength Training in Bone Health (INVEST in Bone Health)', 'orgStudyIdInfo': {'id': 'IRB00058279'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Weight Loss plus Vest', 'interventionNames': ['Device: Vest', 'Behavioral: weight loss program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Weight Loss Plus Resistance Exercise Training', 'interventionNames': ['Behavioral: Resistance Exercise Training', 'Behavioral: weight loss program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Weight Loss', 'interventionNames': ['Behavioral: weight loss program']}], 'interventions': [{'name': 'Vest', 'type': 'DEVICE', 'description': 'Weighted Vest worn \\> or = 8 hours per day', 'armGroupLabels': ['Weight Loss plus Vest']}, {'name': 'Resistance Exercise Training', 'type': 'BEHAVIORAL', 'description': 'Structured exercise training 3 days a week', 'armGroupLabels': ['Weight Loss Plus Resistance Exercise Training']}, {'name': 'weight loss program', 'type': 'BEHAVIORAL', 'description': 'a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)', 'armGroupLabels': ['Weight Loss', 'Weight Loss Plus Resistance Exercise Training', 'Weight Loss plus Vest']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Kristen Beavers, PhD, MPH, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}