NCT06467578 RMR Monitoring Feasibility and Acceptability
| NCT ID | NCT06467578 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Metabolism |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-04-19 |
| Primary Completion | 2025-04-30 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 * 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