MetabolismNCT06467578
RMR Monitoring Feasibility and Acceptability
A study testing Breezing Portable Indirect Calorimeter in people with Metabolism and Obesity, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism, Obesity, Weight Loss
- What is being tested?
- Breezing Portable Indirect Calorimeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 19 Apr 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 19-65 years
- Ability to read, understand, and speak in English
- BMI over 18.5
- Live within a 1-hour radius of UBCO
- Sedentary or recreationally active, defined as: <300-minutes per week of self-reported voluntary exercise at moderate intensity or greater over the past 12-weeks
- Not currently pregnant or lactating, not planning to become pregnant in the next 12 weeks
Show all 12Show fewer
- Ability to attend two in-person sessions at UBCO
- Ability and willingness to fast for 12 hours before each study day visit and at least once a week before completing RMR measures using the portable indirect calorimeter
- Access to a mobile device (i.e., smartphone or tablet) with reliable Bluetooth and Wi-Fi connection for the 6 week study duration
- If applicable:
- For people who occasionally (i.e., <1x/day) use cannabis (including cannabidiol-based products): ability and willingness to abstain from cannabis for two days prior to each study day visit, and the morning of each study visit.
- For people who use cannabis daily: ability and willingness to continue to use the exact same amount of cannabis as they normally use for two days prior to each study day visit, the morning of each study visit (if applicable), and during the 6 week study duration.
Who cannot join
- Current or previous major comorbidities, by self-report, including:
- Cardiovascular disease
- Diabetes (type 1, type 2, pervious gestational)
- Cancer
- Thyroid diseases
- Human immunodeficiency virus or hepatitis B or C
Show all 26Show fewer
- Renal diseases
- Polycystic ovary syndrome
- Uncontrolled/untreated, by self-report:
- Hypertension
- Dyslipidemia
- Sleep disorders
- Severe depression
- Any other condition that may affect energy balance
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia - Okanagan Campus
Kelowna, British Columbia, V1V1V7
Sarah Purcell, PhD, 250 807 9827, sarah.purcell@ubc.ca
About this study
Official title: Feasibility and Acceptability of 6-week Repeated Measures of Resting Metabolic Rate Using a Portable Indirect Calorimeter
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.
Read the detailed description
Study visits:
Participants will be asked to refrain from food and calorie- or caffeine-containing beverages for at least 12 hours, alcohol for at least 24 hours, and vigorous-intensity exercise for at least 48 hours before each study visit.
Baseline study visit (~3-3.5 hours):
Prior to the baseline study visit, participants will meet with a member of the study team to review the consent form to establish participation status. Participants will be required to confirm their body weight using a digital scale. Participants will then be randomized using online software (http://www.randomization.com) in a 1:1 fashion for the order of RMR measurement device (i.e., starting with Breezing than Parvo or vice versa). RMR will be measured with the Parvo for 15-20 minutes after a period of 25-30 minutes of quiet rest. RMR will be measured with the Breezing for 6-10 minutes using the Breezing mobile application. In addition, participants will be provided a series of validated and standard questionnaires to assess psychological and behavioural related parameters during this visit. Finally, participants will be asked to create an account for the Breezing mobile application, will be provided with a activPAL activity monitoring device, and will be instructed as to how to complete the 3-day diet record.
Follow-up study visit (~3-3.5 hours, 6-8 weeks post baseline visit):
Repeat measures will be taken for body weight, RMR (using both devices), and behavioural questionnaires. In addition, Dual X-ray absorptiometry (DEXA; Hologic Model A) will measure participant's fat-mass, fat-free mass, body fat percentage and bone mineral density. Body composition variables will be expressed in absolute terms and controlling for height (e.g., FM index: FM [kg]/height [m2]); FFM will also be expressed in relation to FM (FM:FFM). Study team members will then conduct 5-10-minute user satisfaction interviews, where participants will be asked to comment on a few open-ended statements. The interviews will be descriptively examined and will not be analyzed in-depth or used to create themes.
Repeated RMR assessment (~20-30 minutes/week, for six consecutive weeks post baseline study visit):
Participants will be instructed to use Breezing one time/week on the same day of the week (± one day) and at the same time each morning for six consecutive weeks. Participants will be asked to use Breezing after a night of their typical sleep quality and quantity, immediately after waking while lying down and in a fasted state. Participants will send weekly Breezing measurements to study team via email. Breezing RMR results will be recorded in secure OneDrive, separate from personal identifying data and the email and pdf will be deleted. If the participants Breezing RMR values are outside of an error range of 15% lesser or greater than baseline values for two consecutive weeks a study team member will email the participant to check if the RMR measurement protocol is being adhered to and possibly schedule a Zoom call with study team member using UBC secure Zoom link to review the Breezing device measurement protocol. Each week participants will be emailed a link to a Qualtrics survey as a weekly check-in for measurement adherence. On weeks 1, 3 and 6 participants will be asked to complete the Systems Usability Scale 47 to assess the usability of the Breezing device and Breezing mobile application.
Physical activity behaviour:
Physical activity will be quantified using activPAL activity monitors (PALTechnologies: Glasgow, Scotland) worn on the mid-thigh for seven days after the baseline study visit and for seven days before the follow-up study visit. This device is a type of accelerometer that records information about time spent sitting, lying, standing, and stepping. Data on total step count, time spent in activities of different intensities, sedentary time, and sleep time will be delineated using the activPAL software, PALanalysis. Participants will be asked to track time in bed and napping, exercise and activPAL removal (if applicable) to help interpret the data.
Feasibility and acceptability outcomes will be assessed using descriptive statistics.
- Conditions
- Metabolism, Obesity, Weight Loss
- Being tested
- Breezing Portable Indirect Calorimeter
- Keywords
- resting metabolic rate, portable indirect calorimeter, feasibility, acceptability
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breezing Portable Indirect CalorimeterDevice
Indirect calorimeter with face mask and smartphone compatible application
| Study group | Role | What they receive |
|---|---|---|
| Breezing Portable Indirect Calorimeter | Other | Use Breezing to assess RMR once a week for six weeks Receives: Device: Breezing Portable Indirect Calorimeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Qualtrics survey
Measured: 6 weeks
RMR (portable indirect calorimeter - BreezingTM)
Using Breezing device
Measured: 6 weeks
Satisfaction & feedback (feasibility)
In-person interview
Measured: 6 weeks
Secondary outcomes (11)
Resting metabolic rate (RMR) - metabolic cart indirect calorimeter
Using Parvo device
Measured: 6-8 weeks
Dietary intake
Record of all food and beverages consumed
Measured: 3 days
Physical activity (accelerometry-derived patterns in moderate-to-vigorous activity)
Using activPAL device
Measured: 7 days post-baseline and 7 days pre-follow-up
Self-regulation
Exercise and Eating Self-Regulation Questionnaire (Exercise 350-420; Diet 10-50, optimal outcome is subjective)
Measured: 6-8 weeks
Eating behaviours
Three-Factor Eating Questionnaire Revised 18-item version (TFEQ-R18, Cognitive restraint 6-24; Uncontrolled eating 9-36; and Emotional eating 3-12, optimal outcome is subjective)
Measured: 6-8 weeks
Subjective physical activity
Leisure Time Exercise Questionnaire (0-21, Higher scores indicate better outcome), Barriers Self-Efficacy Scale (BARSE, 0-130, higher scores indicate better outcome) (responses to multiple questionnaires will be considered in assessing this outcome)
Measured: 6-8 weeks
Weight management knowledge questionnaires- Obesity knowledge
Obesity Knowledge Questionnaire (percentage correct; 0-100%, higher scores indicate better outcome)
Measured: 6-8 weeks
Weight management knowledge questionnaires- Physical activity knowledge
Physical Activity Knowledge Questionnaire (Level 1 1-5; Level 2 0-12; Level 3 no min max values; Level 4 1-5, optimal outcome is subjective)
Measured: 6-8 weeks
Body weight
Digital scale (Min dependant on hight (Min BMI = 18.6), no Max, optimal outcome is subjective)
Measured: 6-8 weeks
Weight management knowledge questionnaires- Nutrition knowledge
Weight Management Nutrition Knowledge Questionnaire (percentage correct; 0-100%, optimal outcome is subjective)
Measured: 6-8 weeks
Weight management knowledge questionnaires- Health beliefs and weight efficacy
Compensatory Health Beliefs Scale (17-102, optimal outcome is subjective), Weight Efficacy Lifestyle Questionnaire (WELQ, 0-200, higher scores indicate better outcome) (responses to multiple questionnaires will be considered in assessing this outcome)
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start19 Apr 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolismStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Purcell, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467578
- Sponsor's protocol ID
- H23-03165
- Status last verified
- Jun 2024
- First submitted
- 13 May 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of 6-week Repeated Measures of Resting Metabolic Rate Using a Portable Indirect Calorimeter
- ClinicalTrials.gov ID
- NCT06467578
- Acronym / sponsor ID
- H23-03165
- Conditions
- Metabolism, Obesity, Weight Loss
- Keywords
- resting metabolic rate, portable indirect calorimeter, feasibility, acceptability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study visits:
Participants will be asked to refrain from food and calorie- or caffeine-containing beverages for at least 12 hours, alcohol for at least 24 hours, and vigorous-intensity exercise for at least 48 hours before each study visit.
Baseline study visit (~3-3.5 hours):
Prior to the baseline study visit, participants will meet with a member of the study team to review the consent form to establish participation status. Participants will be required to confirm their body weight using a digital scale. Participants will then be randomized using online software (http://www.randomization.com) in a 1:1 fashion for the order of RMR measurement device (i.e., starting with Breezing than Parvo or vice versa). RMR will be measured with the Parvo for 15-20 minutes after a period of 25-30 minutes of quiet rest. RMR will be measured with the Breezing for 6-10 minutes using the Breezing mobile application. In addition, participants will be provided a series of validated and standard questionnaires to assess psychological and behavioural related parameters during this visit. Finally, participants will be asked to create an account for the Breezing mobile application, will be provided with a activPAL activity monitoring device, and will be instructed as to how to complete the 3-day diet record.
Follow-up study visit (~3-3.5 hours, 6-8 weeks post baseline visit):
Repeat measures will be taken for body weight, RMR (using both devices), and behavioural questionnaires. In addition, Dual X-ray absorptiometry (DEXA; Hologic Model A) will measure participant's fat-mass, fat-free mass, body fat percentage and bone mineral density. Body composition variables will be expressed in absolute terms and controlling for height (e.g., FM index: FM [kg]/height [m2]); FFM will also be expressed in relation to FM (FM:FFM). Study team members will then conduct 5-10-minute user satisfaction interviews, where participants will be asked to comment on a few open-ended statements. The interviews will be descriptively examined and will not be analyzed in-depth or used to create themes.
Repeated RMR assessment (~20-30 minutes/week, for six consecutive weeks post baseline study visit):
Participants will be instructed to use Breezing one time/week on the same day of the week (± one day) and at the same time each morning for six consecutive weeks. Participants will be asked to use Breezing after a night of their typical sleep quality and quantity, immediately after waking while lying down and in a fasted state. Participants will send weekly Breezing measurements to study team via email. Breezing RMR results will be recorded in secure OneDrive, separate from personal identifying data and the email and pdf will be deleted. If the participants Breezing RMR values are outside of an error range of 15% lesser or greater than baseline values for two consecutive weeks a study team member will email the participant to check if the RMR measurement protocol is being adhered to and possibly schedule a Zoom call with study team member using UBC secure Zoom link to review the Breezing device measurement protocol. Each week participants will be emailed a link to a Qualtrics survey as a weekly check-in for measurement adherence. On weeks 1, 3 and 6 participants will be asked to complete the Systems Usability Scale 47 to assess the usability of the Breezing device and Breezing mobile application.
Physical activity behaviour:
Physical activity will be quantified using activPAL activity monitors (PALTechnologies: Glasgow, Scotland) worn on the mid-thigh for seven days after the baseline study visit and for seven days before the follow-up study visit. This device is a type of accelerometer that records information about time spent sitting, lying, standing, and stepping. Data on total step count, time spent in activities of different intensities, sedentary time, and sleep time will be delineated using the activPAL software, PALanalysis. Participants will be asked to track time in bed and napping, exercise and activPAL removal (if applicable) to help interpret the data.
Feasibility and acceptability outcomes will be assessed using descriptive statistics.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breezing Portable Indirect Calorimeter | Other | Device: Breezing Portable Indirect CalorimeterUse Breezing to assess RMR once a week for six weeks |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 19-65 years
- Ability to read, understand, and speak in English
- BMI over 18.5
- Live within a 1-hour radius of UBCO
- Sedentary or recreationally active, defined as: <300-minutes per week of self-reported voluntary exercise at moderate intensity or greater over the past 12-weeks
Key exclusion criteria (26 listed)
- Current or previous major comorbidities, by self-report, including:
- Cardiovascular disease
- Diabetes (type 1, type 2, pervious gestational)
- Cancer
- Thyroid diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breezing Portable Indirect CalorimeterIndirect calorimeter with face mask and smartphone compatible application | Device | Breezing Portable Indirect Calorimeter |
Primary outcome
Adherence
Time frame: 6 weeks
Qualtrics survey
RMR (portable indirect calorimeter - BreezingTM)
Time frame: 6 weeks
Using Breezing device
Satisfaction & feedback (feasibility)
Time frame: 6 weeks
In-person interview
11 secondary outcomes
Resting metabolic rate (RMR) - metabolic cart indirect calorimeter
Time frame: 6-8 weeks
Dietary intake
Time frame: 3 days
Physical activity (accelerometry-derived patterns in moderate-to-vigorous activity)
Time frame: 7 days post-baseline and 7 days pre-follow-up
Self-regulation
Time frame: 6-8 weeks
Eating behaviours
Time frame: 6-8 weeks
Subjective physical activity
Time frame: 6-8 weeks
Weight management knowledge questionnaires- Obesity knowledge
Time frame: 6-8 weeks
Weight management knowledge questionnaires- Physical activity knowledge
Time frame: 6-8 weeks
Body weight
Time frame: 6-8 weeks
Weight management knowledge questionnaires- Nutrition knowledge
Time frame: 6-8 weeks
Weight management knowledge questionnaires- Health beliefs and weight efficacy
Time frame: 6-8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breezing Portable Indirect Calorimeter in people with Metabolism and Obesity, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Purcell, PhD (250 807 9827, sarah.purcell@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.