Change in Six-Minute Walk Test (6MWT)Primary· Baseline, 12 weeks
A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m
Group
Value
95% CI
Develop & Refine MOWI w/o Amulet (2A)
47.5
± 83
Develop & Refine MOWI w Fitbit (2B)
39.3
± 51.6
Develop & Refine MOWI w Fitbit/Protein (2P)
31.8
± 27.8
Change in Gait Speed (m/s)Primary· Baseline, 12 weeks
Gait speed is measured by the time it takes to walk 20 meters. Gait speed predicts disability and mortality (significant change 0.1 m/s).
Group
Value
95% CI
Develop & Refine MOWI w/o Amulet (2A)
0.2
± 0.1
Develop & Refine MOWI w Fitbit (2B)
0.1
± 0.1
Develop & Refine MOWI w Fitbit/Protein (2P)
0.1
± 0.1
Change in Late-Life Function and Disability Instrument (LLFDI)Primary· Baseline, 12 weeks
LLFDI consists of a 32-item function and 16-item disability (life-task) scales that correlate with gait speed and lower limb function. Higher points indicate better function. Individual raw scores range from 0 to 80, scaled scores are 0 to 100. Each was assessed at baseline and at 12 weeks. We report the differences between baseline/follow-up. Positive score change reflect improved physical function.
Group
Value
95% CI
Develop & Refine MOWI w/o Amulet (2A)
8.6
± 8.6
Develop & Refine MOWI w Fitbit (2B)
9.0
± 8.6
Develop & Refine MOWI w Fitbit/Protein (2P)
6.3
± 6.9
Change in Behavioral Activation (Patient Activation Measure)Secondary· Baseline, 12 weeks post study
Patient Activation Measure (PAM) assesses knowledge, confidence and skill for managing health and grouped into 4 levels revealing insights into attitudes, motivators, behaviors \& outcomes. Higher points indicate better activation. Measures are scored 0-100 units. Scores below reflect changes between baseline and follow-up at 12-weeks. A positive change score indicates improvement in activation
Group
Value
95% CI
Develop & Refine MOWI w/o Amulet (2A)
9.2
± 11.3
Develop & Refine MOWI w Fitbit (2B)
18.8
± 14.5
Develop & Refine MOWI w Fitbit/Protein (2P)
11.0
± 10.8
Change in Subjective Health Status (PROMIS) PhysicalSecondary· Baseline, 12-weeks
Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Short Form. PROMIS is a 10-item instrument capturing physical, mental and social aspects of quality of life having undergone quantitative appraisal and is non-proprietary. Higher points indicate better health. Raw scores are scaled to 0-100. 50 is the mean, 10 points indicates 1 standard deviation. Positive change scores listed below indicate an improvement in subjective health
Group
Value
95% CI
Develop & Refine MOWI w/o Amulet (2A)
3.0
± 4.4
Develop & Refine MOWI w Fitbit (2B)
6.4
± 5.3
Develop & Refine MOWI w Fitbit/Protein (2P)
2.3
± 3.6
Change in Weight in kgSecondary· Baseline, 12 weeks
Change in weight in kg
Group
Value
95% CI
Develop & Refine MOWI w/o Amulet (2A)
-4.3
± 3.2
MOWI Weight Loss Maintenance
-3.5238
± 9.11762
Develop & Refine MOWI w Fitbit (2B)
-5.8
± 3.1
Develop & Refine MOWI w Fitbit/Protein (2P)
-3.5
± 2.9
Change in Waist Circumference in cmSecondary· Baseline, 12 weeks post study
Change in waist and hip circumference in cm
Group
Value
95% CI
Develop & Refine MOWI w/o Amulet (2A)
-7.6
± 4.9
Develop & Refine MOWI w Fitbit (2B)
-6.4
± 6.3
Develop & Refine MOWI w Fitbit/Protein (2P)
-14.8
± 45.5
Average Steps/ExpenditureSecondary· Mean steps over 12 week period of time
Average Steps will be measured over a 12 week period
Group
Value
95% CI
Develop & Refine MOWI w Fitbit (2B)
6494
± 3700
Develop & Refine MOWI w Fitbit/Protein (2P)
5127
± 3467
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of ActivitiesSecondary· Change Score between baseline and 12 weeks
CHAMPS is a self-reported tool in older adults that assesses activity levels and types -
Low intensity activities per week
Group
Value
95% CI
Develop & Refine MOWI w Fitbit (2B)
3.9
± 6.9
Develop & Refine MOWI w Fitbit/Protein (2P)
4.5
± 6.9
Moderate intensity activities per week
Group
Value
95% CI
Develop & Refine MOWI w Fitbit (2B)
8.6
± 9.2
Develop & Refine MOWI w Fitbit/Protein (2P)
5.2
± 9.1
Change in Body Composition - Lean MassSecondary· Baseline, 12 weeks
Lean mass was assessed using bioelectrical impedance for 2P and 2B. This technique was not available for MOWI 2A participants and hence not measured
Group
Value
95% CI
Develop & Refine MOWI w Fitbit (2B)
-0.62
± 1.4
Develop & Refine MOWI w Fitbit/Protein (2P)
-1.44
± 1.45
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology-assisted wellness intervention for older adults with obesity.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07403604 — Effect of Insulin Lowering on Lipogenesis
· Phase 1
· recruiting
NCT07509307 — AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee
· Phase 3
· recruiting
NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass
· recruiting
NCT07481630 — A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoart
· Phase 3
· recruiting
NCT07527195 — Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscl
· Phase 1
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center
Last refreshed: 29 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03104192.