RMR Monitoring Feasibility and Acceptability
NCT Number: NCT06467578
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolism|Obesity|Weight Loss
Interventions: DEVICE: Breezing Portable Indirect Calorimeter
Sponsor: University of British Columbia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-04-19
Completion Date: 2025-04-30
Locations: University of British Columbia - Okanagan Campus, Kelowna, British Columbia, V1V1V7, Canada

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.

Primary Outcome Measures: Adherence, Qualtrics survey, 6 weeks|RMR (portable indirect calorimeter - BreezingTM), Using Breezing device, 6 weeks|Satisfaction & feedback (feasibility), In-person interview, 6 weeks
Secondary Outcome Measures: Resting metabolic rate (RMR) - metabolic cart indirect calorimeter, Using Parvo device, 6-8 weeks|Dietary intake, Record of all food and beverages consumed, 3 days|Physical activity (accelerometry-derived patterns in moderate-to-vigorous activity), Using activPAL device, 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), 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), 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), 6-8 weeks|Weight management knowledge questionnaires- Obesity knowledge, Obesity Knowledge Questionnaire (percentage correct; 0-100%, higher scores indicate better outcome), 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), 6-8 weeks|Body weight, Digital scale (Min dependant on hight (Min BMI = 18.6), no Max, optimal outcome is subjective), 6-8 weeks|Weight management knowledge questionnaires- Nutrition knowledge, Weight Management Nutrition Knowledge Questionnaire (percentage correct; 0-100%, optimal outcome is subjective), 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), 6-8 weeks