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RMR Monitoring Feasibility and Acceptability

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Contents

clinicaltrials.gov/study/NCT06467578
Is a
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Clinical study
0

Clinical Study attributes

NCT Number
NCT064675780
Health Conditions in Trial
Metabolism
Metabolism
0
‌
Obesity
0
Weight loss
Weight loss
0
Trial Recruitment Size
200
Trial Sponsor
University of British Columbia
University of British Columbia
0
Clinical Trial Start Date
April 19, 2024
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Primary Completion Date
April 30, 2025
0
Study Completion Date
April 30, 2025
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Other0
Intervention Type
Device0
Interventional Trial Phase
Not Applicable0
Official Name
Feasibility and Acceptability of 6-week Repeated Measures of Resting Metabolic Rate Using a Portable Indirect Calorimeter0
Last Updated
June 24, 2024
0
Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
Breezing Portable Indirect Calorimeter0
Study 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 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.

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