RMR Monitoring Feasibility and Acceptability

NCT06467578 | Recruiting

• 1 other identifier: H23-03165
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolism; Obesity; Weight Loss

Keywords

resting metabolic rate; portable indirect calorimeter; feasibility; acceptability

Outcome Measures

Primary Outcomes (3)

• Adherence

  Qualtrics survey

  6 weeks

• RMR (portable indirect calorimeter - BreezingTM)

  Using Breezing device

  6 weeks

• Satisfaction & feedback (feasibility)

  In-person interview

  6 weeks

Secondary Outcomes (11)

• Resting metabolic rate (RMR) - metabolic cart indirect calorimeter

  6-8 weeks

• Dietary intake

  3 days

• Physical activity (accelerometry-derived patterns in moderate-to-vigorous activity)

  7 days post-baseline and 7 days pre-follow-up

• Self-regulation

  6-8 weeks

• Eating behaviours

  6-8 weeks

Study Arms (1)

Breezing Portable Indirect Calorimeter

OTHER

Use Breezing to assess RMR once a week for six weeks

Device: Breezing Portable Indirect Calorimeter

Interventions

Breezing Portable Indirect Calorimeter DEVICE

Indirect calorimeter with face mask and smartphone compatible application

Breezing Portable Indirect Calorimeter

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia - Okanagan Campus

Kelowna, British Columbia, V1V1V7, Canada

RECRUITING

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Central Study Contacts

Sarah Purcell, PhD

CONTACT

250 807 9827; sarah.purcell@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: June 21, 2024
• Study Start: April 19, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

CA (1)