ChOcolate COnsumption And Blood Pressure (COCOA-BP): A Wearable Devices Pilot Trial

Not Applicable

Completed

• Conditions: Blood Pressure; Health Behavior
• Interventions: Other: Dark Chocolate; Device: Wearable devices

• Registration Number: NCT02764203
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

The COCOA-BP Trial is designed to assess the impact of 50g daily dark chocolate intake on blood pressure and compare outcome data derived from wearable/digital health devices to data derived from standard methods. Additionally, the usability of the wearable technology will be evaluated.

Detailed Description

The COCOA-BP Trial is a prospective, single-center, single-arm, Boston Scientific volunteer trial, designed to assess the impact of 50g daily dark chocolate intake on blood pressure and compare outcome data derived from wearable/digital health devices to data derived from standard methods. Additionally, the usability of the wearable technology will be evaluated.

Study Timeline

• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-06
• Study Start: 2016-09-16
• Primary Completion: 2017-09-12
• Study Completion: 2017-09-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-01
• Last Update Posted: 2017-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Subject is at least 18 years of age
• Subject has an iPhone (5 or higher)
• Subject is willing to comply with all trial requirements
• Subject understands the trial requirements and procedures and provides written informed consent before any trial-specific procedures are performed

Exclusion Criteria

• Anyone part of the study execution team cannot be part of the trial
• Current smoker or history of smoking in the last 5 years (including E-cigarettes)
• Diabetes mellitus including those managed by diet alone
• Medically treated hypertension
• Diagnosed with persistent or frequent irregular heart beat (e.g. atrial flutter, atrial fibrillation)
• Permanent pacemaker or defibrillator implanted
• Subject is a women who is pregnant
• Known allergy to chocolate or cacao products
• Known allergy to skin adhesives

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chocolate consumption	Dark Chocolate	Subjects will consume 50g of dark chocolate for 2 weeks and have their blood pressure compared before chocolate and after chocolate
Chocolate consumption	Wearable devices	Subjects will consume 50g of dark chocolate for 2 weeks and have their blood pressure compared before chocolate and after chocolate

Primary Outcome Measures

Name	Time	Method
Change in resting systolic blood pressure after daily dark chocolate	14 days after daily consumption of dark chocolate

Secondary Outcome Measures

Name	Time	Method
Correlation of physical activity (steps) to resting blood pressure and heart rate	daily, for four weeks
Comparison of blood pressure derived from wearable digital health devices to data derived from standard methods	End of week two and end of week four
Comparison of heart rate derived from wearable digital health devices to data derived from standard methods	End of week two and end of week four