Power of Choice on Autonomy, Motivation, Exercise Adherence, and Cardiorespiratory Fitness

Study Overview
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Brief Summary
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People with elevated blood sugar levels are at increased risk of developing chronic medical conditions such as obesity, type 2 diabetes, and cardiovascular disease. Improving cardiorespiratory fitness (CRF) in adults with elevated blood sugar levels is important for preventing the onset of such medical conditions. The primary aim of this study is to determine whether providing a choice between two different types of exercise in a diabetes prevention intervention improves perceived autonomy, exercise motivation, physical activity behavior, and subsequently CRF to a greater extent than imposed exercise among adults with elevated blood sugar.

Detailed Description
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This trial has been informed by self-determination theory. The theory states that individuals who choose their own activities report increased autonomy and internal reasons/motivations to change a behavior as opposed to external reasons (to satisfy another person's suggestions). Perceived autonomy support and internal motivation for performing a behavior are linked with improved long-term adherence to the behavior change, which subsequently leads to physiological adaptations such as an increase in CRF. The primary outcome of this study is participants' perceived autonomy support after a 4-week diabetes prevention program. The secondary outcomes are 1) changes in exercise-related motivation from baseline to immediately post-intervention and 6-months post-intervention, 2) physical activity behavior 6-months post-intervention while controlling for baseline values, and 3) CRF 6-months post-intervention while controlling for baseline values. Seventy-seven low-active adults between 18-75 years of age with elevated blood sugar levels (HbA1c between 5.7%-6.4% or American Diabetes Association risk assessment >5) have been randomized to a 4-week supervised intervention involving behavioral counseling and one of three exercise conditions: 1) imposed high-intensity interval training (HIIT; n=26); 2) imposed moderate-intensity continuous training (MICT; n=26), or 3) choice between MICT or HIIT (CHOICE; n=24). It is hypothesized that when compared to HIIT and MICT, the CHOICE condition will have greater perceived autonomy support immediately after the 4-week intervention, display more internal motivation immediately after the 4-week intervention, and show greater improvements in physical activity adherence and CRF 6-months post-intervention. This proposed trial will provide theory- and evidence-based information whether providing choice for engaging in HIIT or MICT is associated with greater improvements in perceived autonomy support, motivation regulation, physical activity behavior, and CRF.

Official Title
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The Power of Choice on Autonomy Support, Motivation, Exercise Adherence and Cardiorespiratory Fitness Among Adults With Elevated Blood Glucose

Conditions
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Elevated Blood Sugar

Intervention / Treatment
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* Behavioral: MICT
* Behavioral: HIIT
* Behavioral: CHOICE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 22-45 kg/m2; HbA1c score indicative of elevated blood sugar (5.7-6.4%); Blood pressure of <160/99 mm Hg assessed according to Canadian Hypertension Education Program guidelines; Without diagnosed diabetes; No prior history of cardiovascular disease; Not on hormone replacement therapy; Not on beta-blockers; Cardiovascular medications (e.g., statins) will be allowed if patients are on stable therapy (6 months on same dose) Exclusion Criteria: Taking glucose-lowering medications (i.e. metformin); Any explicit contraindications to exercise (e.g., musculoskeletal injury)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single-centre, 3-arm parallel-group randomized trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MICT<br>Continuous exercise for 30 minutes per session at 60-70% of heart rate max for five times per week, consistent with physical activity guidelines that advocate 150 minutes per week of moderate activity. | Behavioral: MICT<br>* Individuals randomized to MICT will be asked to engage in only MICT 5 times/week for 30 min/session at 60-70% of heart rate max, consistent with physical activity guidelines of 150 min/week of moderate activity. Individuals are asked to engage in only MICT exercise during the 4-week supervised and unsupervised exercise sessions. During the supervised exercise the intensity will be based on the heart rate (HR) monitors and psychophysiological responses of perceived exertion. The exercise training is paired with 30-50 minutes of behavioral counselling that is identical for all three interventions.<br>|
| Active Comparator: HIIT<br>Five repeated vigorous intervals of 1-min duration at 80-90% of heart rate max interspersed with 1-min recovery periods; 3-min warm-up and 2-min cool-down, making the total session duration 15 minutes for five times/week, equated to match the guidelines of 75 min of vigorous exercise per week. | Behavioral: HIIT<br>* Individuals randomized to HIIT will be asked to engage in only HIIT 5 times/week for 4 weeks. HIIT consists of 5 repeated vigorous intervals of 1-min duration at 80-90% of heart rate max interspersed with 1-min recovery periods. A 3-min warm-up and 2-min cool-down are also included, for a total session duration of 15 minutes. This matches the guidelines of 75 min of vigorous exercise per week. During the supervised exercise sessions, intensity will be based on HR monitors and psychophysiological responses of perceived exertion. The exercise training is paired with 30-50 minutes of behavioral counselling that is identical for all three interventions.<br>|
| Experimental: CHOICE<br>Participants will be introduced to HIIT and MICT during sessions 1 and 2 of the 4-week intervention in a counterbalanced randomized order, and will thereafter self-select one of the two exercise types for remaining sessions. Exercise will be matched to the parallel imposed conditions. | Behavioral: CHOICE<br>* Participants will first be familiarized with HIIT and MICT in a randomized, counter-balanced order during supervised sessions 1 and 2, and will subsequently self-select the exercise type for the supervised and unsupervised exercise sessions. The HIIT and MICT protocols will match to the parallel imposed conditions. During the supervised exercise, intensity will also be based on HR monitors and psychophysiological responses of perceived exertion. The exercise training is paired with 30-50 minutes of behavioral counselling that is identical for all three interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Autonomy Support | Individual participants' perceived autonomy support will be measured using the Learning Climate Questionnaire (LCQ) adapted by Williams and Deci. The LCQ is a 15-item self-report questionnaire that measures perceived autonomy support and has been previously validated and shown to have strong internal reliability. The questionnaire uses a 7-point Likert scale ranging from 1 strongly disagree to 7 strongly agree. For this study, the anchoring questions are modified to replace the term instructor with coach. Scoring of individual results is done by averaging individual responses after reverse-coding item #13, with a minimum score of 1 and a maximum score of 7. Higher scores indicate a higher perception of autonomy support. | Four weeks post-intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Motivation Regulation | Participants' motivation regulation is measured using the Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2). The BREQ-2 is a 19-item self-report questionnaire that measures one's motivation to exercise. The questionnaire uses a 5-point Likert scale ranging from 0 not true for me to 4 very true for me. The relative autonomy index (RAI) is used to provide an index of the degree to which participants feel self-determined ranging from -24 to +20, with higher positive scores indicating more autonomous forms of motivation regulation. The RAI is calculated by first averaging each subscale, then multiplying each average by a subscale weighting, and subsequently summing the weighted subscale scores. Weighting for each subscale are as follows: amotivation (-3), external regulation (-2), introjected regulation (-1), identified regulation (+2), intrinsic regulation (+3). | Four weeks post-intervention and 6 months post-intervention while controlling for baseline values. | 
| Physical Activity Behavior (Self-Report) | Physical activity behavior will be measured using the Godin Leisure-Time Exercise Questionnaire (GLTEQ) to assess self-reported physical activity adherence. The GLTEQ requires individuals to report their frequency of engaging in strenuous, moderate, and mild exercise during a typical week in bouts of 15 minutes or longer. Scoring of the GLTEQ consists of first multiplying reported frequencies by their related metabolic equivalent (MET) values (strenuous: 9METs, moderate: 5METs, mild: 3METs), and then summing the products for a total score. Interpretation of the scores follows the categories proposed by Godin, where a score of 24 units or higher indicates an individual is active, a score between 14 and 23 indicates an individual is moderately active, and a score below 14 indicates an individual is insufficiently active. The GLTEQ has been previously validated and shown to be comparable to accelerometry data for measuring moderate-to-vigorous physical activity. | Six months post-intervention while controlling for baseline values. | 
| Physical Activity Behavior (Accelerometry) | Physical activity behavior will also be measured using 7-day triaxial accelerometry data. Participants wear an Actigraph GT3X-BT for seven consecutive days at the top of their right hip at a sampling rate of 100Hz. Accelerometry data is considered valid if the participant wears the accelerometer for a minimum of 10 hours/day and at least 4 of the 7 days of the week. Non-wear time is defined as any period of 60 minutes or longer with no recorded activity counts. Physical activity is measured by summing activity counts in 60-second epochs, and cut-off activity count thresholds for defining intensity follows Troiano and colleagues' convention. Free-living physical activity behavior is operationalized as average daily minutes of MVPA and is calculated by summing both moderate and vigorous activity count minutes and subsequently dividing by the number of valid wear days. | Six months post-intervention while controlling for baseline values. | 
| Physical Activity Behavior (Fitbit) | A wearable activity tracker (Fitbit Luxe™) is also provided to each participant to track physical activity behavior in free-living conditions. In congruence with previous research and similar to accelerometry-based parameters, we define a valid wear day as any day with a minimum of 10 hours of wear time determined by continuous minute-by-minute heart rate recordings. Non-wear time is defined as a period of 60 continuous minutes with no heart rate recordings. A minimum of 4 out of 7 consecutive days of the week are required for the week to be considered valid. Free-living physical activity behavior is operationalized as average daily minutes of MVPA and is calculated by summing the daily minutes spent in moderate and intense activities per day and subsequently dividing by the number of valid wear days. Activity intensity levels are determined by using the Fitbit-derived algorithms, and number of minutes per day at each level are imported into Fitabase. | Six months post-intervention while controlling for baseline values. | 
| Cardiorespiratory Fitness | Participants' cardiorespiratory fitness (CRF) is calculated based on the minutes and seconds participants are able to achieve in a submaximal 12-lead ECG stress test performed at a cardiac rehabilitation clinic. Calculation of CRF is conducted according to Bruce and colleagues' equation for estimated maximal volume of oxygen intake (VO2max) in mL/(kg*min). Calculations are stratified by biological sex, where w is the weighting factor for sex (1=men; 2=women) and t is the duration of the protocol in seconds: VO2max=6.70-2.82w+0.056t | Sex months post-intervention while controlling for baseline values. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autonomy Support, Exercise Motivation, Physical Activity Adherence, Cardiorespiratory Fitness, Prediabetes