Recruiting

Lifestyle Program

Sponsor:

University of British Columbia

Code:

NCT03096002

Conditions

PreDiabetes

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Lifestyle change

Study Details

Brief summary:

The purpose of this study is to address whether inactive individuals with prediabetes who take part in the Small Steps for Big Changes program, which is a 3-week supervised exercise and lifestyle change program with brief counseling, will be more adherent to regular exercise one year after program completion compared to before they took part in the program.

Conditions

PreDiabetes

Study ID

NCT03096002

Start date

Jun 12, 2017

Status verified date

May, 2018

Completion date

Apr, 2019

Anticipated

Primary completion date

Apr, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ability to speak and read English
  • BMI between 25-40 kg/m2 (as measured by body mass and height self-reporting),
  • blood pressure of <160/99 mm Hg assessed according to CHEP guidelines,
  • not diagnosed with type 2 diabetes
  • no prior history of cardiovascular disease
  • not on hormone replacement therapy
  • Cardiovascular medications (e.g., statins) will be allowed if the participant is on stable therapy (6 months on same dose).

Exclusion Criteria, if subjects:

  • take glucose-lowering medications that have changed within the past 6 months;
  • report any explicit contraindications to exercise (e.g., musculoskeletal injury, chest pain during exercise)
  • report having had a heart attack or stroke in the past;
  • report that they are pregnant or plan on becoming pregnant over the next 12 months;
  • have uncontrolled major depression;
  • have bone or joint problem (for example, back, knee, or hip) that could be made worse by a change in physical activity which a physician has not cleared them for to exercise;
  • report that a physician has not cleared their participant for exercise.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Lifestyle change (one-treatment group)

The lifestyle change program is a 3-week program that will introduce participants to a regular healthy lifestyle that includes exercising at least three times per week and the program will highlight simple dietary strategies. There is no randomization to this program - all individuals enrolled will partake in the same program and will be followed up for 12 months after the program has concluded.

Interventions

Lifestyle change

The 3-week lifestyle change program will introduce participants to a regular healthy lifestyle including exercise and dietary changes for reducing sugar intake, reducing refined/processed carbohydrate intake, increasing vegetable consumption. The 3-week program will include six supervised exercise sessions and three exercise sessions performed independently (e.g., at home or outside of the lab). The supervised session will include brief behavioral counseling sessions that teach participants self-regulatory skills to promote independence and long-term adherence to exercising and dietary changes.

Primary outcome measure

  • minutes of moderate to vigorous physical activity [ Time Frame: change from before participants begin the program to 52 weeks after they finish the program for 7 consecutive days ]
  • independent bouts of physical activity [ Time Frame: change from when participants begin the program to 52 weeks after they finish the program ]

Central Contacts and Locations

Central contacts

Mary E Jung, Ph.D.

250 807 9670mary.jung@ubc.ca

Jonathan P Little

250 807 9876jonathan.little@ubc.ca

Locations

YMCA of Okanagan

Recruiting

Kelowna, British Columbia, Canada, V1X 2M9

Contacts

Mary E Jung, PhD

250-807-8419mary.jung@ubc.ca

Principal Investigator:

Mary E Jung, PhD

More Information

Sponsor

University of British Columbia

Last update posted

May 9, 2018

Last verified

May, 2018

Keywords

  • PreDiabetes, Lifestyle intervention, Exercise Behavior, Adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2018-05-09.