Actively Recruiting

Phase Not Applicable
Age: 19Years - 65Years
All Genders
Healthy Volunteers
NCT06467578

RMR Monitoring Feasibility and Acceptability

Led by University of British Columbia · Updated on 2024-06-24

20

Participants Needed

1

Research Sites

53 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

RMR Monitoring Feasibility and Acceptability

Who Can Participate

Age: 19Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 19-65 years
  • Ability to read, understand, and speak English
  • Body mass index (BMI) over 18.5
  • Live within a 1-hour radius of UBCO
  • Sedentary or recreationally active with less than 300 minutes per week of moderate or greater intensity exercise over the past 12 weeks
  • Not currently pregnant or lactating and not planning pregnancy 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 visit and before weekly RMR measurements
  • Access to a smartphone or tablet with reliable Bluetooth and Wi-Fi for 6 weeks
  • For occasional cannabis users (less than once daily): willing to abstain from cannabis two days prior and morning of each visit
  • For daily cannabis users: willing to maintain usual cannabis use during study and prior to visits
Not Eligible

You will not qualify if you...

  • Current or past major health conditions including cardiovascular disease, diabetes (type 1, type 2, gestational), cancer, thyroid diseases, HIV or hepatitis B or C, renal diseases, polycystic ovary syndrome
  • Uncontrolled or untreated hypertension, dyslipidemia, sleep disorders, severe depression
  • Any other condition affecting energy balance
  • Use of medications affecting energy balance or sleep in past 6 months
  • Regular tobacco or nicotine use
  • Starting new prescription medication within 2 weeks before or during study
  • Working night shifts or traveling across more than two time zones within 2 weeks before or during study
  • History of weight loss surgery or extensive bowel resection
  • Current alcohol or substance abuse (AUDIT score ≥15)
  • Current or past eating disorders or high risk based on eating attitudes test
  • Current symptoms of depression (CES-D-10 score ≥10)
  • Weight loss over 5 kg in past 12 weeks or over 20 kg in past 3 years
  • Degree or work experience in energy balance-related fields in past 10 years

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of British Columbia - Okanagan Campus

Kelowna, British Columbia, Canada, V1V1V7

Actively Recruiting

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Research Team

S

Sarah Purcell, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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