NCT03576924

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
3.2 years until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 2, 2025

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

June 21, 2018

Results QC Date

March 3, 2025

Last Update Submit

April 14, 2025

Conditions

Keywords

Autonomy SupportExercise MotivationPhysical Activity AdherenceCardiorespiratory FitnessPrediabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in Exercise Motivation Regulation

    Baseline, four weeks post-intervention, and 6 months post-intervention

  • Change in Physical Activity Behavior (Self-Report)

    Baseline, 6-months after the intervention

  • Change in Physical Activity Behavior (Accelerometry)

    Baseline, 6 months after the intervention

  • Change in Physical Activity Behavior (Fitbit)

    Baseline, 6 months after intervention

  • Change in Cardiorespiratory Fitness

    Baseline, 6 months after intervention

Study Arms (3)

MICT

ACTIVE COMPARATOR

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

HIIT

ACTIVE COMPARATOR

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

CHOICE

EXPERIMENTAL

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

Interventions

MICTBEHAVIORAL

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.

MICT
HIITBEHAVIORAL

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.

HIIT
CHOICEBEHAVIORAL

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.

CHOICE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Taking glucose-lowering medications (i.e. metformin);
  • Any explicit contraindications to exercise (e.g., musculoskeletal injury)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Kelowna, British Columbia, V1V 1V7, Canada

Location

Related Publications (9)

  • Little JP, Safdar A, Wilkin GP, Tarnopolsky MA, Gibala MJ. A practical model of low-volume high-intensity interval training induces mitochondrial biogenesis in human skeletal muscle: potential mechanisms. J Physiol. 2010 Mar 15;588(Pt 6):1011-22. doi: 10.1113/jphysiol.2009.181743. Epub 2010 Jan 25.

    PMID: 20100740BACKGROUND
  • Little JP, Gillen JB, Percival ME, Safdar A, Tarnopolsky MA, Punthakee Z, Jung ME, Gibala MJ. Low-volume high-intensity interval training reduces hyperglycemia and increases muscle mitochondrial capacity in patients with type 2 diabetes. J Appl Physiol (1985). 2011 Dec;111(6):1554-60. doi: 10.1152/japplphysiol.00921.2011. Epub 2011 Aug 25.

    PMID: 21868679BACKGROUND
  • Hood MS, Little JP, Tarnopolsky MA, Myslik F, Gibala MJ. Low-volume interval training improves muscle oxidative capacity in sedentary adults. Med Sci Sports Exerc. 2011 Oct;43(10):1849-56. doi: 10.1249/MSS.0b013e3182199834.

    PMID: 21448086BACKGROUND
  • Kodama S, Saito K, Tanaka S, Maki M, Yachi Y, Asumi M, Sugawara A, Totsuka K, Shimano H, Ohashi Y, Yamada N, Sone H. Cardiorespiratory fitness as a quantitative predictor of all-cause mortality and cardiovascular events in healthy men and women: a meta-analysis. JAMA. 2009 May 20;301(19):2024-35. doi: 10.1001/jama.2009.681.

    PMID: 19454641BACKGROUND
  • O'Donovan G, Owen A, Bird SR, Kearney EM, Nevill AM, Jones DW, Woolf-May K. Changes in cardiorespiratory fitness and coronary heart disease risk factors following 24 wk of moderate- or high-intensity exercise of equal energy cost. J Appl Physiol (1985). 2005 May;98(5):1619-25. doi: 10.1152/japplphysiol.01310.2004. Epub 2005 Jan 7.

    PMID: 15640382BACKGROUND
  • Jung ME, Bourne JE, Little JP. Where does HIT fit? An examination of the affective response to high-intensity intervals in comparison to continuous moderate- and continuous vigorous-intensity exercise in the exercise intensity-affect continuum. PLoS One. 2014 Dec 8;9(12):e114541. doi: 10.1371/journal.pone.0114541. eCollection 2014.

    PMID: 25486273BACKGROUND
  • Jung ME, Bourne JE, Beauchamp MR, Robinson E, Little JP. High-intensity interval training as an efficacious alternative to moderate-intensity continuous training for adults with prediabetes. J Diabetes Res. 2015;2015:191595. doi: 10.1155/2015/191595. Epub 2015 Mar 30.

    PMID: 25918728BACKGROUND
  • National Research Council (US) Panel on Handling Missing Data in Clinical Trials. The Prevention and Treatment of Missing Data in Clinical Trials. Washington (DC): National Academies Press (US); 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK209904/

    PMID: 24983040BACKGROUND
  • Preacher KJ, Hayes AF. SPSS and SAS procedures for estimating indirect effects in simple mediation models. Behav Res Methods Instrum Comput. 2004 Nov;36(4):717-31. doi: 10.3758/bf03206553.

    PMID: 15641418BACKGROUND

MeSH Terms

Conditions

HyperglycemiaPrediabetic State

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Results Point of Contact

Title
Dr. Mary Jung
Organization
University of British Columbia

Study Officials

  • Mary E. Jung, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a single-centre, 3-arm parallel-group randomized trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 21, 2018

First Posted

July 5, 2018

Study Start

October 1, 2021

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

May 2, 2025

Results First Posted

May 2, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations