Validation of a Personal Breath Analyzer for Diet and Energy Expenditure Assessment and Management (Breezing)

Banner Health

Status: Withdrawn

Conditions: Obesity

Treatments: Other: Dietary

Study type: Interventional

Funder types: Other

Identifiers

NCT02981160

Breezing Study

Details and patient eligibility

About

The purpose of the research is to determine energy expenditure rates and diet and/ physical activity metabolic features of an individual using current state technologies and a new technology created at the Center for Bioelectronics and Biosensors at ASU. This is a pilot study which intent is to validate this device for use in the weight loss patient population.

This study will involve research of metabolic physiological parameters that are measured through the breath of the individuals, together with other physical parameters (weight, height, date of birth, fat and lean body composition via bio-impedance, heart rate, blood pressure, and breathing rate) assessed in the clinic, and a questionnaire about diary physical activities. The study will involve withdrawn of breath samples at resting conditions, and under diets or physical activities regimes.

This instrument will assist our patients in terms of tailoring their diet/nutrition through their weight loss journey prior and after surgery. As a new technology, it will be an excellent tool for compliance assessment and engagement with the Weight Loss Program as well as for long term follow up.

Full description

The Breezing® device is a new technology locally invented in the state of Arizona that uses a sensor cartridge and a flow meter to determine the rate of consumed oxygen and produced carbon dioxide in the breath. The sensing technology of the new indirect calorimeter, which used a cell-phone camera as the optical detector. The current Breezing® device uses a code to carry calibration parameters of a single-use sensor cartridge, which can be scanned and recognized by the mobile application (app). The device is 6.0 oz. (170 g), and 1.8 in × 2.1 in × 4.8 in (4.7 cm × 5.4 cm × 12.3 cm), and connects wirelessly to an iOS mobile device, using Bluetooth 4.0 technology.

The mobile device (phone or tablet) receives data from the device, processes information, and then provides test results and summaries through a graphic user interface. It determines the energy expenditure from the measurement of VO2 and VCO2 according to the Weir equation, along with RQ. In addition to the sensor cartridge, the Breezing® device is used with a non-rebreathing 2-valvesmouthpiece.

This new device will provide a more precise information regarding metabolic rate in our Bariatric Patients to better tailor their preoperative diet and monitor their weight loss.

Up to date, this device was never used or validated before in the Bariatric population under this setting.

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females or Males between 18 and 50 yo
• Class II and Class III Obesity (BMI 35 and above)

Exclusion criteria

• No Obesity. Patients with normal BMI

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Standard Care Group

No Intervention group

Description:

The participants assigned to this group will follow a standard weight loss program for 12-months. This patients will be instructed by the Weight loss program registered dietitian/diet tech in clinic in terms of nutrition regimen, daily intake and calories.Patients will be followed up monthly as per clinic protocol. All visits will include physical measurements including body mass index (BMI) based on height and weight, blood pressure, and body composition (fat percentage). Body composition will be assessed during clinic visits by bio-impedance. Waist circumference (cm) will be measured at the umbilicus.

Mobile Device Assistant Group

Experimental group

Description:

This group will follow the same weight loss protocol, monitoring, and clinic visits as the standard weight loss group described above, but will also use the mobile health tool (Breezing) to track REE every visit. This data will be loaded onto an accompanying electronic pad using the Breezing "app" and will be transmitted electronically to the study investigators who will use the information to adjust dietary and physical activity recommendations and targets. The test will be performed at initial visit, 2 weeks, 1, 3, 6 and 12 months after started.

Treatment:

Other: Dietary