RMR Monitoring Feasibility and Acceptability

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-65
SponsorUniversity of British Columbia

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Age 19-65 years

Ability to read, understand, and speak in English

BMI over 18.5

Live within a 1-hour radius of UBCO

Disqualifiers

Cardiovascular disease

Diabetes (type 1, type 2, pervious gestational)

Cancer

Thyroid diseases

Trial design

Design model

Single group

Treatments tested in this trial

  • Breezing Portable Indirect Calorimeter

    Device

    Indirect calorimeter with face mask and smartphone compatible application

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Breezing Portable Indirect CalorimeterOther 1 intervention

Trial outcomes

Primary outcomes

1

Adherence

Qualtrics survey

Time frame
6 weeks
2

RMR (portable indirect calorimeter - BreezingTM)

Using Breezing device

Time frame
6 weeks
3

Satisfaction & feedback (feasibility)

In-person interview

Time frame
6 weeks

Secondary outcomes

1

Resting metabolic rate (RMR) - metabolic cart indirect calorimeter

Using Parvo device

Time frame
6-8 weeks
2

Dietary intake

Record of all food and beverages consumed

Time frame
3 days
3

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

Using activPAL device

Time frame
7 days post-baseline and 7 days pre-follow-up
4

Self-regulation

Exercise and Eating Self-Regulation Questionnaire (Exercise 350-420; Diet 10-50, optimal outcome is subjective)

Time frame
6-8 weeks

Other outcomes

Sponsors and contacts

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