Image Based Mobile System for Dietary Assessment and Coaching

NCT03897426 | Completed DMC

• 1 other identifier: HHSN261201400053C_SBIR 308
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Vignet partnered with The George Washington University Hospital to conduct a randomized control trial (RCT) with to evaluate the system's potential to improve health outcomes for patients with CVD. Results from the RCT have the potential to be applied to patients in other chronic disease contexts.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• Compare the Mediterranean Diet Compliance Score at 3 months between the intervention and standard of care groups

  The primary endpoint is to compare the Mediterranean Diet Compliance Score, on a scale of 0 to 14, at 3 months between the intervention and standard of care groups. Basic comparisons will be made using Wilcoxon tests to compare medians between the two groups with repeated measures analysis of variance used to compare differences across groups and over time. The higher value represents a better outcome. Subscales will not be combined.

  3 months

• Compare the Mediterranean Diet Compliance Score at 6 months between the intervention and standard of care groups

  The primary endpoint is to compare the Mediterranean Diet Compliance Score, on a scale of 0 to 14, at 6 months between the intervention and standard of care groups. Basic comparisons will be made using Wilcoxon tests to compare medians between the two groups with repeated measures analysis of variance used to compare differences across groups and over time. The higher value represents a better outcome. Subscales will not be combined.

  6 months

Study Arms (2)

Standard-of-care arm

NO INTERVENTION

Patients randomized to the Standard-of-care-arm were provided 60 minutes of RD time for consultation through in person visits.

Intervention arm

EXPERIMENTAL

Mediterranean Diet - Remote Coaching using a Mobile App. Patients randomized to the intervention arm were allotted 60 minutes of RD time through a Mobile App (for remote consultation), given an instruction booklet on using Mobile App, directed to a website for additional instruction on its use, and have the app set up to establish connectivity to the RD. Remote coaching by RD was the intervention.

Behavioral: Mediterranean Diet - Remote Coaching using a Mobile App

Interventions

Mediterranean Diet - Remote Coaching using a Mobile App BEHAVIORAL

Patients randomized to the intervention arm will be then given an instruction booklet on using Mobile App, directed to a website for additional instruction on its use, and have the app set up to establish connectivity to the RD.

Intervention arm

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive patients with ongoing cardiology care with a cardiologist based at the GWU MFA and are expected to remain in the care of that cardiologist for at least 6 months.
• Patients must own their own Android- or Apple iOS-based smartphone with a data plan.
• Patients must give informed consent.
• English language requirement.
• At least 5th grade literacy level as assessed with Rapid Estimate of Adult Literacy in Medicine (REALM).\[ \]
• Patients must demonstrate an ability to download and install the Vignet FitNinja app.
• Patient must be at least 18 years of age.
• Patient with evidence of prior acute coronary syndrome, history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, ischemic non-embolic stroke/TIA, or peripheral artery disease presumed to be of atherosclerotic origin.
• Patient is on optimal medical therapy as determined by the primary cardiologist at time of enrollment.

You may not qualify if:

• Clinical instability at time of enrollment.
• Co-morbid medical disease that would preclude ability to participate in a nutrition intervention study (e.g., digestive disease with fat intolerance, life expectancy less than 5 years, severe neurologic, psychiatric or endocrine abnormalities).
• Immunodeficiency or HIV-positive status.
• Illegal drug use, alcoholism or daily alcohol intake \>80 g/d.
• BMI\>40 kg/m2.
• Inability or unwillingness to change dietary habits as predicted by the Prochaska and DiClemente stages of change model.\[ \]
• Inability or unwillingness to adhere to a Mediterranean diet (e.g., religious/moral reasons, disorders or chewing or swallowing).
• Allergies to major components of the Mediterranean diet (i.e., nuts, olive oil).
• Participation in any drug trial or use of any investigational drug within the past one year.
• Patients who are institutionalized, lack autonomy, are non-ambulatory, lack a stable address, or have a history of missing more than one appointment in the past 6 months.
• Patients with an acute infection or inflammation (e.g., pneumonia) in the past 3 months.
• Pregnancy.

Sponsors & Collaborators

• Vibrent Health: lead
• George Washington University: collaborator

Related Publications (1)

• Choi BG, Dhawan T, Metzger K, Marshall L, Akbar A, Jain T, Young HA, Katz RJ. Image-Based Mobile System for Dietary Management in an American Cardiology Population: Pilot Randomized Controlled Trial to Assess the Efficacy of Dietary Coaching Delivered via a Smartphone App Versus Traditional Counseling. JMIR Mhealth Uhealth. 2019 Apr 23;7(4):e10755. doi: 10.2196/10755.

  PMID: 31012860 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2017
• First Posted: April 1, 2019
• Study Start: March 4, 2016
• Primary Completion: June 2, 2017
• Study Completion: August 31, 2017
• Last Updated: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share