Using an API to Commercialize an Evidence-Based Weight Loss Intervention
NCT ID: NCT02812264
Last Updated: 2020-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
209 participants
INTERVENTIONAL
2017-06-07
2019-12-01
Brief Summary
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Detailed Description
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Participants (n=206) will be randomly assigned to use either the intervention app (intervention arm; n=103) or a weight loss app of their choosing (attention control arm; n=103) for 12 months. Assessments will take place at baseline, and 3, 6, and 12 months.
Statistical analysis: A linear mixed modeling approach will be used to test the hypothesis. Observed weight vs. time plots will be analyzed for all participants to discern general trends in weight change. The model will include an intervention effect, a time effect, an intervention by time interaction, and a random intercept.
In exploratory analysis, investigators will examine weight change across subgroups of interest; investigators will add the subgroup variable and its interaction with the intervention indicator to the primary model. All analyses will be evaluated at the 0.05 significance level.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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API App
use of API weight loss mobile application for 12 months, plus fitness tracker and scale.
API App
Mobile application that uses API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale
fitness tracker
fitness tracker to monitor physical activity and sleep patterns that is connected to transfer data to app
scale
Connected scale that will transfer weight information to app
Attention Control
use of non-API app for weight loss over 12 months, plus fitness tracker and scale.
Non-API App
Mobile application that does not use API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale.
fitness tracker
fitness tracker to monitor physical activity and sleep patterns that is connected to transfer data to app
scale
Connected scale that will transfer weight information to app
Interventions
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API App
Mobile application that uses API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale
Non-API App
Mobile application that does not use API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale.
fitness tracker
fitness tracker to monitor physical activity and sleep patterns that is connected to transfer data to app
scale
Connected scale that will transfer weight information to app
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* between 21-65 years old
* BMI between 25-40 kg/m2
* ownership and use of an Android smartphone during past 6 months with no plans to change phone/service during study
* consent for research team to monitor app utilization
Exclusion Criteria
* prior or planned bariatric surgery
* psychiatric hospitalization in past 12 months
* pregnancy, nursing, or planned pregnancy during the study
* history of cardiovascular disease (CVD) event
* self-reported history of an eating disorder
* use of medication for diabetes mellitus
* mobility restrictions for which exercise is contraindicated
* history of a condition (e.g., lithium, steroids, anti-psychotics) that would affect weight measurement, for which weight loss is contraindicated
* current participation in another weight treatment study and/or recent weight loss \>10%
* investigator discretion for safety reasons
21 Years
65 Years
ALL
Yes
Sponsors
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Coeus Health, LLC
INDUSTRY
Responsible Party
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Locations
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Coeus Health Offices
State College, Pennsylvania, United States
Countries
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Other Identifiers
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