Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467578
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-05-13
Brief Title:
RMR Monitoring Feasibility and Acceptability
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Feasibility and Acceptability of 6-week Repeated Measures of Resting Metabolic Rate Using a Portable Indirect Calorimeter
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Personalizing weight management programs produces more weight loss than generic programs possibly through improved self-efficacy confidence in ones 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 n25 participants among which 10 participants will have a body mass index BMI of 30kgm2 classified as having obesity and the remaining 10 participants will have a body mass index BMI of 299kgm2 classified as not having obesity The baseline study visit will evaluate participants 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 timeweek 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 participants 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 3-35 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 httpwwwrandomizationcom in a 11 fashion for the order of RMR measurement device ie 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 3-35 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 participants 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 eg FM index FM kgheight m2 FFM will also be expressed in relation to FM FMFFM 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 minutesweek for six consecutive weeks post baseline study visit
Participants will be instructed to use Breezing one timeweek 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
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 3-35 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 httpwwwrandomizationcom in a 11 fashion for the order of RMR measurement device ie 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 3-35 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 participants 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 eg FM index FM kgheight m2 FFM will also be expressed in relation to FM FMFFM 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 minutesweek for six consecutive weeks post baseline study visit
Participants will be instructed to use Breezing one timeweek 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None