Clinical trial NCT06924346: Exercise Snacks in Obesity
Official title: Efficacy of Exercise Snacks in Real-World Settings in Individuals Living With Obesity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2025-04-11
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To conduct a randomized control trial to determine the feasibility and preliminary efficacy of a 12-week technology-enabled exercise snacks intervention with behaviour change counselling for improving cardiorespiratory fitness and various markers of cardiometabolic health in previously inactive adults living with obesity.

Detailed description: Participants will be randomized into an Exercise Snacks or a Placebo Exercise group for 12 weeks. The former will involve bodyweight exercises performed with vigorous effort and the latter will involve low-intensity stretching and mobility exercises. Following baseline testing, individualized interventions will be delivered via a customized mobile application ("app") or web platform. Participants will be instructed to perform a minimum of 4 isolated bouts of prescribed exercises per day on at least 5 days per week. Each bout will be one minute in duration. The interventions will be individualized and consider exercise preferences and physical abilities (e.g., fitness, musculoskeletal issues), and be adaptable to multiple environments (e.g., home, work). To facilitate this, participants will have a pre-intervention meeting wherein any physical limitations will be documented, and a research assistant trained in health behaviour change techniques will provide a brief exercise counselling session designed to individualize the intervention to the participant's preferences, abilities, and lifestyle. After 12 weeks, participants will be asked to return to the lab for follow-up testing.

Eligibility criteria: Inclusion Criteria:

* Aged 35-64 years.
* Habitually engaging in \< 150 min moderate-to-vigorous physical activity per week.
* Body mass index 30-45 kg/m2 or 27.5-45 for participants who self-identify as being of Asian or Southeast Asian origin.
* Waist circumference: \>88cm for females and \>102cm for males, or \>80 cm for females and \>90 cm for male participants who self-identify as being of Asian or Southeast Asian.
* Not currently diagnosed with a cardiometabolic disease (e.g., coronary artery disease, stroke, diabetes, non-alcoholic fatty liver disease).
* Taking ≤2 commonly prescribed medications for the prevention of cardiometabolic diseases (e.g., statins, antihypertensives).
* Not a current smoker
* Cleared to engage in physical activity using the Get Active Questionnaire and, if applicable, consultation with a health care provider or Qualified Exercise Professional.
* Access to a computer, tablet or smartphone for intervention delivery and tracking.
* Ability to read and write in English.

Exclusion Criteria:

* Chronic musculoskeletal condition or recent (within 2 years) cardiovascular event preventing participation in exercise.
* Lack of internet access.
* Angina upon exertion assessed by the Rose Angina Questionnaire.
* Prescribed beta-blockers that can compromise the validity of heart rate measurements. during the exercise test.
* Have a scheduled surgical procedure within the next 3-4 months that would prevent exercise participation.
* Currently participating in another clinical trial that interferes with the study procedures.
* Currently pregnant or planning on becoming pregnant during the intervention (i.e., within the next 4 months).
* Uncontrolled high blood pressure (\>160/90 mmHg)

Primary outcomes:
measure: Determine the number of individuals living with obesity that are eligible to participate in the trial
timeFrame: through study completion, an average of 18 months
measure: Determine the number of eligible participants who would be willing to take part in this trial
timeFrame: through study completion, an average of 18 months
measure: Determine the number and percentage of participants retained after the 12-week intervention
timeFrame: after the 12-week intervention
measure: Determine the number of one-minute exercise bouts performed during the 12-week intervention
timeFrame: during the 12 weeks
Secondary outcomes:
measure: Change in cardiorespiratory fitness measured before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in lower body muscular endurance before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in upper body maximal strength before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in waist circumference before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in weight before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in body mass index before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in fasting glucose measured before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in fasting insulin measured before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in systolic blood pressure measured before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in diastolic blood pressure measured before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in physical activity assessed during the first and last weeks of the intervention
timeFrame: weeks 1 and 12
Other outcomes:
Locations:
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