Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06467578

RMR Monitoring Feasibility and Acceptability

Sponsor: University of British Columbia

View on ClinicalTrials.gov

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.

Official title: Feasibility and Acceptability of 6-week Repeated Measures of Resting Metabolic Rate Using a Portable Indirect Calorimeter

Key Details

Gender

All

Age Range

19 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-04-19

Completion Date

2025-04-30

Last Updated

2024-06-24

Healthy Volunteers

Yes

Conditions

Metabolism Obesity Weight Loss

Interventions

DEVICE

Breezing Portable Indirect Calorimeter

Indirect calorimeter with face mask and smartphone compatible application

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. * 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. Exclusion Criteria: * 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 * 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)

Locations (1)

University of British Columbia - Okanagan Campus

Kelowna, British Columbia, Canada