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NCT03104192

MOWI Research Pilot

Completed NA Results posted Last updated 29 November 2022
What this trial tests

NA trial testing Develop & Refine MOWI w/o Amulet in Obesity in 69 participants. Completed in 11 January 2020.

Timeline
1 September 2017
Primary endpoint
3 January 2019
11 January 2020

Quick facts

Lead sponsorDartmouth-Hitchcock Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposehealth services research
Enrollment69
Start date1 September 2017
Primary completion3 January 2019
Estimated completion11 January 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Dartmouth-Hitchcock Medical Center

Who can join

65 and older, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Grip Strength Primary · Baseline, 12 weeks

Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.

GroupValue95% CI
Develop & Refine MOWI w/o Amulet (2A)6.2± 5.1
Develop & Refine MOWI w Fitbit (2B)-2.6± 5.2
Develop & Refine MOWI w Fitbit/Protein (2P)4.3± 3.4
Change in 5 Times Sit-to-Stand (STS) Primary · Baseline, 12 weeks

STS measures lower limb strength (minimal change 2.3 s).

GroupValue95% CI
Develop & Refine MOWI w/o Amulet (2A)-2.9± 2.9
Develop & Refine MOWI w Fitbit (2B)-1.5± 1.7
Develop & Refine MOWI w Fitbit/Protein (2P)-2.6± 2.2
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

GroupValue95% 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).

GroupValue95% 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.

GroupValue95% 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

GroupValue95% 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) Physical Secondary · 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

GroupValue95% 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 kg Secondary · Baseline, 12 weeks

Change in weight in kg

GroupValue95% 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 cm Secondary · Baseline, 12 weeks post study

Change in waist and hip circumference in cm

GroupValue95% 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/Expenditure Secondary · Mean steps over 12 week period of time

Average Steps will be measured over a 12 week period

GroupValue95% 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 Activities Secondary · 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
GroupValue95% 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
GroupValue95% 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 Mass Secondary · 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

GroupValue95% 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.

Develop & Refine MOWI w/o Amulet (2A)
Serious: 1/9 (11%)
Deaths: 0/9
MOWI Weight Loss Maintenance
Serious: 0/23 (0%)
Deaths: 0/23
Develop & Refine MOWI w Fitbit (2B)
Serious: 3/14 (21%)
Deaths: 0/14
Develop & Refine MOWI w Fitbit/Protein (2P)
Serious: 1/14 (7%)
Deaths: 0/14

Serious adverse events (2 terms)

ReactionSystemDevelop & Refine MOWI w/o …MOWI Weight Loss MaintenanceDevelop & Refine MOWI w Fi…Develop & Refine MOWI w Fi…
Chest painCardiac disorders
HeadacheNervous system disorders
Other adverse events (6 terms — click to expand)

ReactionSystemDevelop & Refine MOWI w/o …MOWI Weight Loss MaintenanceDevelop & Refine MOWI w Fi…Develop & Refine MOWI w Fi…
MusculoskeletalMusculoskeletal and connective tissue disorders
NeurologicalNervous system disorders
CardiovascularCardiac disorders
GastrointestinalGastrointestinal disorders
ConstitutionalGeneral disorders
RespiratoryRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Chest pain, Headache.

Data from ClinicalTrials.gov NCT03104192 adverse events section.

Sponsor's own description

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):

  1. Weight management intervention identifies association of decreased DNA methylation age with improved functional age measures in older adults with obesity.
    Petersen CL, Christensen BC, Batsis JA. · · 2021 · cited 15× · PMID 33653394 · DOI 10.1186/s13148-021-01031-7
  2. A Community-Based Feasibility Study of Weight-Loss in Rural, Older Adults with Obesity.
    Batsis JA, Petersen CL, Cook SB, Al-Nimr RI, et al · · 2020 · cited 8× · PMID 32907522 · DOI 10.1080/21551197.2020.1817226
  3. Relationship of Handgrip Strength and Asymmetry with Walking Ability in Older Adults with Excess Adiposity.
    Cook SB, Chaudhry BA, Petersen CL, Mackenzie TA, et al · · 2024 · cited 2× · PMID 39007213 · DOI 10.1002/adbi.202400068
  4. Adapting natural language processing and sentiment analysis methods for an intervention in older adults: Positive perceptions of health and technology.
    Petersen CL, Li X, Stevens CJ, Gooding TL, et al · · 2023 · cited 1× · PMID 38116325 · DOI 10.4017/gt.2023.22.1.824.06

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Other recruiting trials for Obesity

Currently open trials in the same condition.

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Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing