Motivating Adolescent Fitness

Exercise Training Clinical Trial

— MOTAFIT  

Official title:

Motivating Adolescent Fitness

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06409793
• Other study ID #: UBC MOTAFIT
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: May 2024
• Source: University of British Columbia
• Contact: Jodie L Koep, PhD
• Phone: 1-250-807-9873
• Email: jodie.koep[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The researchers are investigating whether adding mobile technology to a home-based exercise counselling program makes it easier for youth to begin and maintain regular exercise. Participants who joins the study will receive exercise counselling from an exercise specialist, but half of all participants will receive mobile technology - a fitness watch - that links to a mobile phone App. The mobile App allows the exercise specialist to provide personalized feedback throughout the program via the fitness watch. The investigators are interested to know whether the fitness watch and mobile App will make it easier for youth to achieve their exercise goals. Both groups will be compared to an active control group, who will receive no exercise program.

Description:

Purpose: The investigators aim to undertake an experimental trial using exercise training in adolescents, evaluating a theoretical model where mHealth technology, allowing biometric informed feedback and coaching, is incorporated into a structured home-based exercise and physical activity (PA) intervention. The overall objective is to have an evidence-based exercise and PA intervention ready to evaluate in a future randomised controlled trial (RCT). Hypothesis: It is hypothesized that this approach will increase both habitual PA and adherence to structured exercise of the appropriate intensity to promote improvements in cardiorespiratory fitness and vascular function. Justification: Current physical activity guidelines suggest adolescents should accumulate at least 60 minutes of moderate to vigorous physical activity (MVPA) per day. Yet globally, more than 80% of adolescents fail to achieve the recommended level of daily MVPA, and less than 25% of Canadian adolescents are sufficiently physically active. Adolescence is a time when sedentary habits predominantly manifest. Sedentary time increases by approximately 100 minutes/day between the ages 12 and 16 years, and there is a disproportionate number of inactive adolescent girls (82%) compared to boys (71%). Clearly current strategies to encourage appropriate levels of physical activity in adolescence are inadequate. It is important to note that the current MVPA guidelines lack the intensity associated with the enhancement of cardiorespiratory fitness in youth (~85-90% of heart rate maximum).Further, the extant data show that habitual physical activity is not related, or at best weakly related to direct laboratory measures of cardiorespiratory fitness in youth. If we aspire to improve cardiorespiratory or vascular health in our younger population, we need to find ways to engage adolescents in sufficient exercise i.e., 40-60 minutes, 3 to 4 times per week at ~85-90% of heart rate maximum. Objectives: Primary Objective 1) Determine the number of sedentary adolescents that are eligible to participate, the proportion of these who would be willing to take part in this trial, and their characteristics, and the number of participants retained at 6-months. Secondary Objectives 1. Adherence to the exercise training. 2. Estimate precision of potential outcome measures required for sample size estimations for the definitive RCT. 3. Intervention acceptability Research Design: The study is a randomised controlled intervention, whereby participants will complete pre-randomisation baseline testing (T1) before a 3-month supported PA and exercise intervention is completed. Immediately post-intervention (T2) and 6-months after the intervention is completed Statistical Analysis: The proportion of eligible patients who consent to participate in the pilot will be presented, along with the proportions in each intervention group completing each follow up assessment and the reasons for withdrawal. Descriptive characteristics and outcome data will be summarized overall and by intervention group, as mean (standard deviation) for normally distributed continuous variables, median (interquartile range) for non-normally distributed continuous variables, and number (percentage) for categorical variables. Interview data will be analysed using thematic analysis, which will allow the research team to discuss emerging themes and help the research team to explore the barriers and facilitators to the intervention and refine the theoretical model, assessing which elements of the intervention. are most effective for participants. As this is a pilot study there will be no formal comparisons between groups in the intervention.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 16 Years

Eligibility

Inclusion Criteria:

• Male or Female
• Aged 13-16 years
• Be comfortable communicating in English

Exclusion Criteria:

• Aged <13 or >16
• Inability to increase level of activity or exercise
• Not owning a smartphone/ or having no data plan or access to Wi-Fi
• Currently meeting the recommended exercise guidelines
• Have congenital cardiac abnormalities (e.g., tetralogy of Fallot)
• Have a known respiratory disease (e.g., asthma)
• Have a known metabolic disease (e.g., Type 1 diabetes)
• Are pregnant

Related Conditions & MeSH terms

• Exercise Training

Intervention

Behavioral:
• mHealth
A 3-month structured exercise and PA intervention, supported by an exercise specialist, with a 3-month follow-up

Locations

Country	Name	City	State
Canada	University of British Columbia	Kelowna	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	MOSS ROCK PARK FOUNDATION

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eligibility to participate in the intervention	The number of adolescents approached and reasons for not joining the study; Number of participants approached to participate, percentage attending/ dropout throughout the intervention	Baseline, and follow up at weeks 4,8,12
Primary	Enrolment in the intervention	Percentage of adolescents attending at 3-month post and 6-month follow up and reasons for drop-out.	Baseline, week 12
Secondary	Adherence	Adherence to the exercise training. Assessed as the number of prescribed sessions completed (as a percentage), and as the percentage of each exercise session spent in desired heart rate zones (80-95% heart rate max).	12 weeks
Secondary	Precision of potential outcome measures of cardiorespiratory fitness	Estimate precision of potential outcome measures required for sample size estimations for the definitive RCT. Maximal oxygen uptake will be assessed on an bike ergometer ramp incremental test to exhaustion. This will be compared from pre compared to post intervention	Baseline, week 12, week 24
Secondary	Precision of potential outcome measures of peripheral vascular function	Estimate precision of potential outcome measures required for sample size estimations for the definitive RCT. This is assessed using ultrasound to assess peripheral endothelial function of the brachial artery at baseline compared to post intervention and follow up assessment.	Baseline, week 12, week 24
Secondary	Precision of potential outcome measures of cerebrovascular function	Cerebrovascular function will be assessed using ultrasound of the internal carotid artery and vertebral artery for measures of blood flow and shear rate. This will be compared from baseline to post intervention.	Baseline, week 12, week 24
Secondary	Acceptability of the exercise training program	This will be assessed using validated PACES 5-point likert scales for enjoyment of exercise sessions, self efficacy, positive and negative affect and perceived behavioural control. These will be assessed on a 5 point scale from 1-5 of participants subjective feelings throughout the intervention, and compared to participants between different arms of the intervention	baseline, week 6 and week 12