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

NCT02981160 | Withdrawn

• 1 other identifier: Breezing Study
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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 The study will involve withdrawn of breath samples at resting conditions, and under diets or physical activities regimes.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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Improve weight loss measures

  Improve weight loss from a standard weight loss program from a mobile breath analyzer device. The device may provide more precise information regarding the metabolic rate in bariatric patients, this device may better tailor patients preoperative diet and assist in monitoring their weight loss.

  12 months

Study Arms (2)

Standard Care Group

NO INTERVENTION

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

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.

Other: Dietary

Interventions

Dietary OTHER

The REE testing will be done with the Breezing device, a breath analyzer developed at Arizona State University. The Breezing device is an indirect calorimetry analyzer that measures the rate of oxygen consumption and carbon dioxide production, and determines how much energy the body is burning (REE), and the type of nutrients the body uses to produce energy (energy source). The Breezing device is a cellphone-size, battery-operated, portable technology that syncs with smartphones and electronic pads. The patients will be asked to breathe into a mouthpiece connected to the Breezing device; the data will be then beamed wirelessly to the device. The breath analysis data will displayed on the screen in conjunction with an estimate of total calories burned each day (total energy expenditure, TEE).

Mobile Device Assistant Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- No Obesity. Patients with normal BMI

Sponsors & Collaborators

• Banner Health: lead
• Arizona State University: collaborator
• University of Arizona: collaborator

Study Sites (2)

Banner Gateway Medical Center

Gilbert, Arizona, 85234, United States

Location

Banner Estrella Medical Center

Phoenix, Arizona, 85037, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bariatric Surgeon

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: December 5, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: April 13, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)