Portable Device for Weight Management

Overseen By Sarah Purcell, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Energy balance, Sleep affecting

Disqualifiers: Cardiovascular disease, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Obesity is a leading risk factor for chronic diseases such as type 2 diabetes, cancer, and cardiovascular disease. Generic weight management programs that target dietary intake and physical activity have been shown to be ineffective in maintaining weight loss beyond a 6-month period. Personalizing weight management programs produces more weight loss than generic programs, possibly through improved self-efficacy (confidence in one's ability to control weight through behavior). One way to personalize diet goals for individuals is by resting metabolic rate (RMR; 'metabolism'). This study will explore adherence and satisfaction of 6-weeks repeated at-home measures of metabolism using a portable device in healthy adults with and without obesity. Relationships among adherence and satisfaction outcomes to health behavior variables will be explored using dietary recalls, exercise monitors and questionnaires. Investigators will conduct a 6-week, one-arm feasibility study in order to address these questions. Twenty men and women ages 19-65 will be recruited (up to n=25 participants), among which 10 participants will have a body mass index (BMI) of ≥30kg/m2 (classified as having obesity), and the remaining 10 participants will have a body mass index (BMI) of \< 29.9kg/m2 (classified as not having obesity). The baseline study visit will evaluate participant's anthropometric measures, RMR using the ParvoMedics TrueOne 2400 and Breezing indirect calorimeters, psychological and behavioural related parameters. An activPAL device will be provided to measure participant physical activity. Completion of a 3-day diet record following the baseline study visit, in which participants keep a record of all food and beverages consumed over 2 weekdays and 1 weekend, is required. Participants will be asked to use the Breezing device from home to measure their RMR one time/week on the same day of the week (± one day) and at the same time each morning for six consecutive weeks following the baseline visit. A weekly Qualtrics survey will be sent to participants to monitor adherence. A follow-up visit after the six weeks will assess participant's body composition using a Dual X-ray Absorptiometry (DEXA), in addition to completion of a user satisfaction interview with a study team member for descriptive analysis. The measures taken at the baseline study visit will be repeated at the follow-up visit.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using regular medication that affects energy balance or sleep, you may not be eligible to participate.

What data supports the effectiveness of the Breezing Portable Indirect Calorimeter treatment for weight management?

The Breezing Portable Indirect Calorimeter is based on indirect calorimetry, which is a gold standard for measuring energy expenditure. This method helps customize a person's energy needs and nutrient delivery, potentially improving nutrition therapy outcomes and aiding in weight management. ^{1 2 3 4 5}

Is the Breezing Portable Indirect Calorimeter safe for use in humans?

The Breezing Portable Indirect Calorimeter, also known as Breezing Med, has been validated for accuracy and reliability in measuring metabolic rates, and it has FDA clearance, indicating it meets safety standards for use in humans. ^{6 7 8 9 10}

How does the portable device for weight management differ from other treatments?

This portable device for weight management is unique because it uses indirect calorimetry to measure resting metabolic rate (RMR), which helps tailor calorie intake for weight loss. Unlike traditional methods, this device is more affordable, convenient, and can be used in various settings, making it easier for individuals to manage their weight effectively. ^{2 8 9 11 12}

Eligibility Criteria

This trial is for men and women aged 19-65 who are either classified as having obesity with a BMI of ≥30kg/m2 or not having obesity with a BMI <29.9kg/m2. Participants must be healthy adults willing to track their metabolism at home using the Breezing device weekly, keep a food diary, and wear an exercise monitor.

Inclusion Criteria

BMI over 18.5

Access to a mobile device (i.e., smartphone or tablet) with reliable Bluetooth and Wi-Fi connection for the 6 week study duration

Ability to attend two in-person sessions at UBCO

Exclusion Criteria

I have or had major health issues like heart disease, diabetes, cancer, HIV, or others.

Currently or in the past six months: use of regular medication that may affect energy balance, or sleep, regular use of tobacco or nicotine products, starting any new prescription medication within two weeks of the first study day visit or planning to do so during the study, working night shifts or traveling across more than two time zones within two weeks of and throughout the study, history of surgical procedure for weight loss at any time (e.g., gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve); history of extensive bowel resection for other reasons, current alcohol or substance abuse (score ≥ 15 on the Alcohol Use Disorders Identification Test (AUDIT) 32, current or past history of eating disorders including anorexia nervosa, bulimia, binge eating disorder (self-report or score >20 on the Eating Attitudes Test - 26 (EATS-26) questionnaire) 33, current symptoms of depression (score ≥ 10 on the Center for Epidemiological Studies Depression Scale, 10-item version (CES-D-10))34, weight loss >5kg in past 12 weeks for any reason, weight loss of >20 kgs in past 3 years for any reason, degree or previous work experience (in the past 10 years) in fields highly related to energy balance (e.g., those exercise or nutrition)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including anthropometric measures, RMR using ParvoMedics and Breezing devices, and psychological and behavioral questionnaires.

1 day

1 visit (in-person)

Treatment

Participants use the Breezing device to measure RMR weekly at home for six weeks, complete weekly Qualtrics surveys, and use activPAL activity monitors.

6 weeks

6 visits (virtual)

Follow-up

Participants undergo follow-up assessments including body composition using DEXA, repeat RMR measurements, and user satisfaction interviews.

1 day

1 visit (in-person)

Treatment Details

Interventions

• Breezing Portable Indirect Calorimeter

Trial Overview The study tests how feasible and satisfying it is for participants to use the Breezing Portable Indirect Calorimeter at home over six weeks to measure their resting metabolic rate (RMR). It also examines how this self-monitoring relates to diet, physical activity, and psychological factors.

Participant Groups

Group I: Breezing Portable Indirect Calorimeter Experimental Treatment 1 Intervention

Use Breezing to assess RMR once a week for six weeks

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Findings from Research

Indirect calorimetry is the gold standard for accurately measuring energy expenditure in clinical settings, which is crucial for assessing patients' energy needs and optimizing nutrition therapy.

Recent technological advancements have made indirect calorimeters more user-friendly, portable, and affordable, encouraging their increased use to enhance individualized patient care and improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indirect calorimetry: a practical guide for clinicians. Haugen, HA., Chan, LN., Li, F.[2017]

The Q-NRG® indirect calorimeter demonstrated high accuracy in measuring oxygen consumption (VO2), carbon dioxide production (VCO2), and energy expenditure (EE), with measurement errors of less than 1% in vitro and minimal differences compared to mass spectrometry in vivo.

The device showed excellent intra- and inter-unit precision, with coefficients of variation (CV%) of ≤1% for VO2 and EE, indicating it is a reliable tool for real-time energy expenditure measurement in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the accuracy and precision of a new generation indirect calorimeter in canopy dilution mode. Delsoglio, M., Dupertuis, YM., Oshima, T., et al.[2021]

A new bedside measuring instrument for indirect calorimetry has been developed to accurately assess energy expenditure in critically ill patients, offering a practical solution for healthcare providers.

This instrument is user-friendly, requires minimal maintenance, and has low operational costs, while its accuracy is validated to be comparable to existing measurement methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Determinations by indirect calorimetry need not be expensive and technically complicated. A new measurement system and its validation]. Höltermann, W., Leuchter, L., Lukasewitz, P., et al.[2006]

Indirect calorimetry is a valuable tool for accurately assessing resting energy expenditure, which helps in designing personalized nutritional regimens for patients based on their specific clinical conditions.

By controlling the testing environment and accounting for clinical factors, indirect calorimetry can reduce complications from overfeeding and lead to cost savings by avoiding unnecessary nutritional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of indirect calorimetry in clinical nutrition. McClave, SA., Snider, HL.[2017]

Indirect calorimetry (IC) significantly improves energy delivery in critically ill patients, leading to a reduction in short-term mortality compared to traditional predictive equations, based on a meta-analysis of 8 randomized controlled trials involving 991 adults.

The use of IC-guided nutrition did not increase the duration of mechanical ventilation or length of ICU and hospital stays, and the rate of adverse events was similar between IC and control groups, suggesting it is a safe and effective approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energy delivery guided by indirect calorimetry in critically ill patients: a systematic review and meta-analysis. Duan, JY., Zheng, WH., Zhou, H., et al.[2021]

The Vmax Encore indirect calorimeter is precise for measuring oxygen consumption (VO2) and resting metabolic rate (RMR) in spontaneously breathing individuals, with minimal differences from the Deltatrac device (4.5% lower for VO2 and 4.1% lower for RMR).

However, both devices showed imprecision in measuring carbon dioxide production (VCO2) and respiratory quotient (RQ), with significant discrepancies in 10% or more of the measurement pairs, indicating a limitation in their accuracy for these parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of an indirect calorimeter using n-of-1 methodology. Frankenfield, DC., Ashcraft, CM., Wood, C., et al.[2020]

The Breezing Med device, a novel wearable technology, has been validated against the FDA-cleared MGC CPX Ultima metabolic cart for accurately measuring Resting Energy Expenditure (REE), showing strong correlation and equivalence in results.

This device is user-friendly and can be used at home, making it particularly valuable for telemedicine applications, especially during the COVID-19 pandemic and for individuals with limited access to healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study of a novel portable indirect calorimeter to a reference breath-by-breath instrument and its use in telemedicine settings. Mora, SJ., Sprowls, M., Tipparaju, VV., et al.[2022]

The Gem handheld indirect calorimeter has been validated in 12 studies, showing it is accurate in measuring resting metabolic rate (RMR) with a mean difference of less than 1% compared to Douglas-bag methods, indicating its reliability for assessing daily energy needs.

While some studies suggest the Gem may measure RMR slightly lower than traditional metabolic carts, it generally performs comparably, making it a valid tool for energy assessment in both adults and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review on use of a handheld indirect calorimeter to assess energy needs in adults and children. McDoniel, SO.[2022]

A pilot study involving 19 overweight and obese adolescents found that a portable indirect calorimeter reliably measures resting metabolic rate (RMR), showing no significant difference compared to the traditional indirect calorimeter (P = .22).

The portable device demonstrated a high reliability with an intraclass correlation coefficient of 0.91, suggesting it is a valid alternative for assessing RMR in clinical settings for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Resting Metabolic Rate in Overweight and Obese Adolescents With a Portable Indirect Calorimeter: A Pilot Study for Validation and Reliability. Henes, ST., Johnson, A., Toner, M., et al.[2017]

The BIOPAC indirect calorimeter is effective for measuring resting energy expenditure (REE) in healthy older adults, especially when using a newly developed prediction equation that improved accuracy significantly, with 72.9% of subjects' REE measurements falling within 10% of the actual values.

However, the BIOPAC calorimeter is not suitable for use in frail older individuals, indicating that while it is a good tool for healthy seniors, caution is needed when considering its application in more vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the BIOPAC indirect calorimeter for determining resting energy expenditure in healthy free-living older people. Khalaj-Hedayati, K., Bosy-Westphal, A., Müller, MJ., et al.[2019]

Indirect calorimetry is identified as the most effective method for determining calorie needs during nutrition support, ensuring patients receive appropriate energy intake.

The article reviews advancements in indirect calorimetry technology and provides practical guidance for clinicians on how to accurately evaluate and apply energy expenditure measurements in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring energy metabolism with indirect calorimetry: instruments, interpretation, and clinical application. Holdy, KE.[2017]

In a study of 39 overweight women, the hand-held indirect calorimeter provided significantly different estimates of resting energy expenditure (REE) and total energy expenditure (TEE) compared to standardized prediction equations, indicating a lack of agreement between the two methods.

Less than 50% of the prediction equation values were within 10% of the calorimeter measurements, suggesting that these equations may not be reliable for accurately estimating energy needs in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand-held indirect calorimeter offers advantages compared with prediction equations, in a group of overweight women, to determine resting energy expenditures and estimated total energy expenditures during research screening. Spears, KE., Kim, H., Behall, KM., et al.[2009]

References

1. United States pubmed.ncbi.nlm.nih.gov

Indirect calorimetry: a practical guide for clinicians. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of the accuracy and precision of a new generation indirect calorimeter in canopy dilution mode. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

[Determinations by indirect calorimetry need not be expensive and technically complicated. A new measurement system and its validation]. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Use of indirect calorimetry in clinical nutrition. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Energy delivery guided by indirect calorimetry in critically ill patients: a systematic review and meta-analysis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Validation of an indirect calorimeter using n-of-1 methodology. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Comparative study of a novel portable indirect calorimeter to a reference breath-by-breath instrument and its use in telemedicine settings. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Systematic review on use of a handheld indirect calorimeter to assess energy needs in adults and children. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Assessing Resting Metabolic Rate in Overweight and Obese Adolescents With a Portable Indirect Calorimeter: A Pilot Study for Validation and Reliability. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Validation of the BIOPAC indirect calorimeter for determining resting energy expenditure in healthy free-living older people. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Monitoring energy metabolism with indirect calorimetry: instruments, interpretation, and clinical application. [2017]

12. United States pubmed.ncbi.nlm.nih.gov

Hand-held indirect calorimeter offers advantages compared with prediction equations, in a group of overweight women, to determine resting energy expenditures and estimated total energy expenditures during research screening. [2009]