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Power of Choice on Exercise Adherence and Cardiovascular Health

Sponsor
University of British Columbia (Other)
Overall Status
Recruiting
CT.gov ID
NCT03576924
Collaborator
Heart and Stroke Foundation of Canada (Other)
201
Enrollment
1
Location
3
Arms
43
Anticipated Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

People with prediabetes have blood sugar levels that are higher than normal and is linked to the development of cardiovascular disease (CVD). Improving cardiorespiratory fitness (CRF) in adults with prediabetes is important for preventing CVD. The primary aim of this study is to improve the CRF among adults with prediabetes by improving exercise adherence through providing choice to self-select their own exercise type and intensity.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Imposed-MICT
  • Behavioral: Imposed-HIIT
  • Behavioral: CHOICE
 N/A

Detailed Description

This trial has been informed by self-determination theory. The theory states that individuals who choose their own activities report increased internal reasons/motivations, as opposed to external reasons (to satisfy another person's suggestions) for the behavior. Internal motivation for performing a behavior are linked with increased pleasure with the behavior and improved adherence.

The primary outcome is improvement in CRF from baseline to 12-months post-intervention. The secondary outcomes are changes in exercise adherence from baseline to 6- and 12-month post-intervention. Tertiary outcomes include self-reported changes in in-task affective responses during the exercise intervention, as well as baseline to 6- and 12-month post-intervention changes in exercise-related motivation and enjoyment in free-living, unsupervised exercise. A total of 201 low active adults (18 to 70 years) with prediabetes will be randomized to a 3-week supervised intervention involving behavioral counseling and one of three exercise conditions, either: 1) imposed high-intensity interval training (Imposed-HIIT; n=67/group); 2) imposed moderate-intensity continuous training (Imposed-MICT), or 3) choice between MICT or HIIT (CHOICE). It is hypothesized that the CHOICE condition will have higher improvements in CRF (primary outcome) from baseline to 12-month post-intervention, and exercise adherence (secondary outcome) from baseline to 6- and 12-months post-intervention, compared to individuals in the IM-MICT or IM-HIIT. For the tertiary outcomes, the CHOICE condition will show greater in-task affective responses during the exercise intervention. We further except greater changes in exercise-related motivation and enjoyment for the CHOICE condition from baseline to 6- and 12-months post-intervention compared to IM-HIIT and IM-MICT conditions. This proposed trial would provide theory- and evidence-based information whether providing choice for engaging in HIIT or MICT is associated with improvements in CRF, exercise adherence, and exercise enjoyment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
201 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a single-centre, parallel-group randomized controlled trial.This is a single-centre, parallel-group randomized controlled trial.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Power of Choice on Exercise Adherence and Cardiovascular Health in Prediabetes
Actual Study Start Date :
Feb 1, 2019
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Imposed-MICT

Continuous exercise for 30 minutes per session at 60-65% of heart rate max for five times per week, consistent with physical activity guidelines that advocate 150 minutes per week of moderate activity.

Behavioral: Imposed-MICT
Moderate-Intensity Continuous Training (MICT) is continuous exercise for 30 min/session at 60-65% of heart rate max for 5 times/week, consistent with the physical activity guidelines of 150 min/week of moderate activity. Individuals are asked to engage in MICT exercise only (IM-MICT) during the supervised and unsupervised exercise sessions. During the supervised exercise the intensity will be based on the HR monitors, and affective and psychophysiological responses of perceived exertion. The exercise training is paired with 30 min behavioural counselling that is identical for all three interventions.
Active Comparator: Imposed-HIIT

Five repeated vigorous intervals of 1-min duration at 85-90% of heart rate max with 1-min recovery periods, with 3-min warm-up and 2-min cool-down, making the total session duration 15 min for five times/week, equated to match the guidelines of 75 min of vigorous exercise per week.

Behavioral: Imposed-HIIT
Individuals randomized to IM-HIIT will be asked to engage in High-Intensity Interval Training (HIIT) exercise only, which is 5 repeated vigorous intervals of 1-min duration at 85-90% of heart rate max with 1-min recovery periods, with 3-min warm-up and 2-min cool-down. Total session duration is 15 min for 5/week and it matches the guidelines of 75 min of vigorous exercise per week. During the supervised and unsupervised exercise sessions participants will perform a 15 min bout of HIIT. During the supervised exercise the intensity will be based on the HR monitors, and affective and psychophysiological responses of perceived exertion. The exercise training is paired with 30 min behavioural counselling that is identical for all three interventions.
Experimental: CHOICE

Participants will always self-select the exercise type that they will do, either the IM-HIIT or the IM-MICT protocols, which will be matched to the parallel imposed conditions.

Behavioral: CHOICE
Participants will first be familiarized with HIIT and MICT in randomized, counter-balanced order and subsequently they will always self-select the exercise type for the supervised and unsupervised exercise sessions. The IM-HIIT and IM-MICT protocols will match to the parallel imposed conditions. During the supervised exercise the intensity will also be based on affective and psychophysiological responses of perceived exertion. Throughout the 3-week intervention as well as during the 12-month follow-up, participants in the CHOICE condition will be told to choose either HIIT or MICT each time they exercise. The exercise training is paired with 30 min behavioural counselling that is identical for all three interventions.

Outcome Measures

Primary Outcome Measures

  1. Cardiorespiratory fitness (VO2peak) [Approximately 12 months: Changes from baseline to 12-month post-intervention]

    Cardiorespiratory fitness (VO2peak) will be assessed by a maximal treadmill exercise test using a modified Bruce protocol.

Secondary Outcome Measures

  1. Exercise adherence [Approximately 6 and 12 months: Changes from baseline to 6- and 12-month post-intervention.]

    Exercise adherence will be objectively measured for 7 consecutive days at baseline, 6-months, and 12-months post-intervention using a tri-axial accelerometer (ActiGraphTM wGT3X-BT, LCC, Fort Walton Beach FL, USA).

Other Outcome Measures

  1. Exercise motivation [Approximately 6 and 12 months: Changes from baseline to 6- and 12-month post-intervention.]

    The Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) will be used to measure exercise-related motivation. The measure assesses amotivation, external, introjected, identified and intrinsic motivation based on the theoretical framework of self-determination theory.

  2. Exercise enjoyment [Approximately 6 and 12 months: Changes from baseline to 6- and 12-month post-intervention.]

    The Physical Activity Enjoyment Scale (PACES) will be used to assess perceived enjoyment of exercise.

  3. In-task affective responses [Changes during the 3-week supervised exercise intervention]

    The Feeling Scale (FS) is a single item measure that will be used to assess displeasure-pleasure during supervised exercise training sessions.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • BMI 22-45 kg/m2;

  • HbA1c score indicative of prediabetes (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;

  • 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;

  • fasting triglycerides ≥5.5 mmol/l;

  • any explicit contraindications to exercise (e.g., musculoskeletal injury)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of British Columbia Kelowna British Columbia Canada V1V 1V7

Sponsors and Collaborators

  • University of British Columbia
  • Heart and Stroke Foundation of Canada

Investigators

  • Principal Investigator: Mary E. Jung, PhD, University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mary Jung, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier:
NCT03576924
Other Study ID Numbers:
  • G-18-0022225
First Posted:
Jul 5, 2018
Last Update Posted:
Oct 28, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mary Jung, Associate Professor, University of British Columbia
Physical activity adherence
Exercise motivation
Exercise enjoyment
Prediabetes

Study Results

No Results Posted as of Oct 28, 2019